Unassociated Document
As filed with the Securities and Exchange Commission on April 10, 2008

Registration No. 333-_______

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

CHINA SKY ONE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Nevada
(State or other jurisdiction of incorporation or organization)

2833
 
87-0430322
(Primary Standard Industrial
 Classification Code Number)
 
(I.R.S. Employer
Identification Number)

Room 1706, No. 30 Di Wang Building, Gan Shui Road,
Nandang District, Harbin, People’s Republic of China 150001
86-451-53994073 (China)
(Address, including zip code, and telephone number, including area
code, of registrant’s principal executive offices)

(Name, address, including zip code, and telephone number,
including area code, of agent for service)

Copies to:

Jeffrey A. Rinde, Esq.
Hodgson Russ LLP
1540 Broadway, 24 th Floor
New York, NY 10036

As soon as practicable after the effective date of this Registration Statement
(Approximate date of commencement of proposed sale to the public)
 
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box: x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer o            Accelerated filer x
Non-accelerated filer o            Smaller reporting company  o


 
CALCULATION OF REGISTRATION FEE

Title of Each Class of Securities
to be Registered
 
Amount to be Registered (1)
 
Proposed Maximum Offering Price Per Unit (2)
 
Proposed Maximum Aggregate
Offering Price (2)
 
Amount of
Registration Fee
 
Common stock, $.001 par value per share
   
2,860,835 shares
 
$
10.20
 
$
28,449,452
 
$
1,120
 
 
                         
Common stock, $.001 par value per share (3)
   
750,000 shares
 
$
10.20
 
$
7,650,000
 
$
301
 
 
                         
Common stock, $.001 par value per share (4)
   
239,168 shares
 
$
10.20
 
$
2,439,483
 
$
97
 
                           
Common stock, $.001 par value per share (5)
   
50,000 shares
 
$
10.20
 
$
510,000
 
$
201
 
 
                         
Common stock, $.001 par value per share (6)
   
50,000 shares
 
$
10.20
 
$
510,000
 
$
201
 
 
                         
Total
   
3,950,003 shares
       
$
49,758,935
 
$
1,920
 
                           
 
(1) In accordance with Rule 416(a), the Registrant is also registering hereunder an indeterminate number of shares that may be issued and resold resulting from stock splits, stock dividends and similar transactions and anti-dilution provisions.
 
(2) Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457 under the Securities Act; calculated based on the average of the bid and ask price for the Registrant’s common stock on March 26, 2008, as reported on the OTC Bulletin Board.
 
(3) Represented by shares of common stock underlying Class A Warrants held by selling securityholders, exercisable at $12.50 per share, expiring July 31, 2011.
 
(4) Represented by shares of common stock underlying callable warrants exercisable at $3.50 per share, expiring on October 10, 2008.
 
(5) Represented by shares of common stock underlying consulting warrants issued to a former executive, exercisable at $3.00 per share, expiring December 20, 2008.
 
(6) Represented by shares of common stock underlying placement agent warrants exercisable at $3.50 per share, expiring on December 23, 2008.

THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.

 
 
SUBJECT TO COMPLETION, DATED APRIL 9, 2007

PROSPECTUS

China Sky One Medical, Inc.

3,950,003 Shares of Common stock

Offered by Selling Securityholders

This prospectus relates to the resale from time to time of up to 3,950,003 shares of the common stock of China Sky One Medical, Inc., a Nevada corporation, by the selling securityholders described in the section entitled “Selling Securityholders” beginning on page 40 in this prospectus. The shares being sold by the selling securityholders includes 2,860,835 shares and 1,089,168 shares of our common stock issuable upon exercise of various outstanding warrants.

China Sky One will not receive any proceeds from the sale of the shares by the selling securityholders to the public. If any of the warrants are exercised so that the underlying shares may be sold in this offering, we will receive the exercise price of these warrants, which exercise prices vary between $3.00 and $12.50 per share.

The selling securityholders may offer and sell any of the shares of our common stock from time to time at fixed prices, at market prices or at negotiated prices, and may engage a broker, dealer or underwriter to sell the shares. For additional information on the possible methods of sale that may be used by the selling securityholders, you should refer to the section entitled “Plan of Distribution” on page 55 of this prospectus.

Our common stock is approved for quotations on the OTC Bulletin Board quotation service under the symbol “CSKI”. The closing bid price of our common stock on March 26, 2008 was $9.00.

Brokers or dealers effecting transactions in the shares should confirm the registration of these securities under the securities laws of the states in which transactions occur or the existence of an exemption from registration.

Certain selling securityholders and any participating broker-dealers may be deemed to be “underwriters” within the meaning of the Securities Act of 1933, and any commissions or discounts given to any such broker-dealer may be regarded as underwriting commissions or discounts under the Securities Act of 1933. See “Selling Securityholders” and “Plan of Distribution”.

Investing in the common stock of China Sky One involves a high degree of risk. You should invest in the common stock only if you can afford to lose your entire investment. See “Risk Factors” beginning on page 5.

The information in this prospectus is incomplete and may be changed. The selling securityholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is _________, 2008


 
 
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE INFORMATION DIFFERENT FROM THAT CONTAINED IN THIS PROSPECTUS. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS ACCURATE ONLY AS OF THE DATE OF THIS PROSPECTUS REGARDLESS OF THE TIME OF DELIVERY OF THIS PROSPECTUS, OR OF ANY SALE OF OUR COMMON STOCK.
 
TABLE OF CONTENTS 
 
   
5
 
   
9
 
   
17
 
   
18
 
   
31
 
   
40
 
   
42
 
   
42
 
   
43
 
   
48
 
   
56
 
   
57
 
   
58
 
   
59
 
   
62
 
   
62
 
Change of Accountants
   
 
 
   
62
 
   
64
 
 
4

 
PROSPECTUS SUMMARY

This summary contains basic information about us and this offering. Because it is a summary, it does not contain all of the information that you should consider before investing in the common stock. You should carefully read this entire prospectus, including the section entitled “Risk Factors” and our financial statements and the notes contained in this prospectus, before making an investment decision.

China Sky One Medical, Inc.

China Sky One Medical, Inc. (“China Sky One”) , is a Nevada corporation formed on February 7, 1986, formerly known as Comet Technologies, Inc. (“Comet”).  On July 26, 2006, after our acquisition of a China based nutritional supplements business, we changed our name from “Comet Technologies, Inc.” to “China Sky One Medical, Inc.”  Our executive offices are located at Room 1706, No. 30 Di Wang Building, Gan Shui Road, Nandang District, Harbin, People’s Republic of China 150001, and our Phone number in the PRC is 86-451-53994073.

We are engaged, exclusively through our PRC based indirect subsidiaries described below, in the development, manufacture, marketing and sale of over-the-counter, branded nutritional supplements and over-the-counter plant and herb based pharmaceutical and medicinal products.   Our principal products are external use Traditional Chinese Herbal Remedies/ Medicines commonly referred to in the industry as “TCM.” We have evolved into an integrated manufacturer, marketer and distributor of external use Chinese medicine products sold primarily in PRC and through PRC domestic pharmaceutical chains and have been expanding our worldwide sales effort as well.  We sell both our own manufactured products, as well as medicinal and pharmaceutical products manufactured by others in the PRC.   

All of our business is conducted in the PRC, through our indirect subsidiary in the PRC, Harbin Tian Di Ren Medical Science and Technology Company (“TDR”), and TDR’s subsidiaries.

We acquired our current PRC based business on May 30, 2006 by acquiring all of the shares of common stock of American California Pharmaceutical Group, Inc., a California corporation formed on December 16, 2003 (“ACPG”), from its shareholders in exchange for 10,193,377 shares of our common stock (approximately 93% of our common stock at the time), resulting in a change of control of the Company, then known as Comet Technologies, Inc. This transaction is treated as a reverse merger for accounting purposes. At the time of this acquisition, ACPG had already owned TDR and its subsidiaries, which it acquired in 2005. ACPG does not have its own operations or revenues other then its ownership of TDR.

TDR, formerly known as “Harbin City Tian Di Ren Medical Co.,” was originally formed in 1994 and maintained its principal executive office in Harbin City of Heilongjiang Province, in the PRC. TDR was reorganized and incorporated as a limited liability company on December 29, 2000, under the “Corporation Laws and Regulations” of the PRC. At the time of the TDR Acquisition by ACPG in December of 2005, TDR had two wholly-owned subsidiaries, Harbin First Bio-Engineering Company Limited and Kangxi Medical Care Product Factory, until July, 2006, when the two were merged, with Harbin First Bio-Engineering Company Limited as the surviving subsidiary of TDR.

We have also recently organized Harbin Tian Qing Biotech Application Company as a wholly-owned PRC subsidiary of TDR, to conduct research and development in the areas of tissue and stem cell banks, which is described in more detail below.   

On October 16, 2006, the Company successfully entered into the field of research and development of tissue and stem cell banks, with the establishment of Harbin Tian Qing Biotech Application Company (“Harbin Biotech”).  The Health Department of Heilongjiang Province, on the basis of the evaluation of results from experts, issued a document approving and authorizing the Company to enter into the above-mentioned development areas.  Harbin Biotech, now a wholly-owned subsidiary of the Company, obtained legal operation rights in these fields, which prevents other companies from entering the same fields in Heilongjiang Province.

On April 3, 2008, TDR completed an acquisition pursuant to an Equity Transfer Agreement dated February 22, 2008, between TDR and Heilongjiang Tianlong Pharmaceutical, Inc., a corporation organized under the laws of the PRC (“Heilongjiang”), which is in the business of manufacturing external-use pharmaceuticals. Our TDR subsidiary previously acquired the Beijing sales office of Heilongjiang in mid 2006. Pursuant to the Equity Transfer Agreement, TDR acquired 100% of the issued and outstanding capital stock of Heilongjiang from Heilongjiang’s sole stockholder, in consideration for an aggregate of approximately $8,300,000, consisting of (i) $8,000,000 in cash, and (ii) shares of common stock of the parent company, China Sky One with a dollar value of $300,000(24,809 shares, $.001 par value per share).
 
5



Summary of Offering

General

The Company is not offering any securities in this registration statement and all securities will be sold by certain selling securityholders.

As of March 20, 2008, there were 14,852,214 shares of common stock outstanding, which includes 2,860,835 outstanding shares of our common stock being registered in this prospectus for resale by the selling securityholders. The sale of these shares and other shares may have an adverse effect on the market price for our common stock.
 
The common stock of China Sky One is traded on the OTC Bulletin Board under the trading symbol “CSKI”.

Securities Being Registered
 
Common stock
 
The Company is registering 3,950,000 shares of which 2,860,835 are outstanding shares of common stock being offered for resale by certain selling securityholders named in this prospectus. The Company will not receive any of the proceeds from the sales of these securities.
 
Common stock Underlying Warrants
 
We are also registering for resale by certain Selling Securityholders, 1,089,168 shares of common stock issuable upon exercise of warrants (but are not registering the warrants themselves) to held by them. We will receive proceeds only from the exercise of the warrants but will not receive proceeds from the sale of these securities by the selling securityholders. The warrants are exercisable at various prices. A summary of these warrants are as follows:
 
·
750,000 shares issuable upon exercise of Class A Warrants exercisable at $12.50 per share, issued to investors in connection with our private offering in January 2008, exercisable between July 31, 2008 and July 31, 2011,
   
·
239,168 shares issuable upon exercise of callable warrants exercisable at $3.50 per share (originally, 500,000 callable warrants, many of which have been exercised the shares of which are being registered hereby), expiring October 10, 2008 and held by certain investors in our private offering of securities in October of 2006,
   
·
50,000 shares of common stock issuable upon exercise of warrants exercisable at $3.00 per share, issued to Mr. Jack M. Gertino, a former executive of the Company, and expiring December 23, 2008, and
   
·
50,000 shares of common stock issuable upon exercise of warrants exercisable at $3.50 per share, issued to American Eastern Securities, Inc. (and its assigns) and expiring on October 10, 2008.
 
The above does not include 1,000,000 shares underlying warrants exercisable at $2.00 per share, issued to certain previous investment bankers of the Company in 2006, which are not being registered but which, if sold, could have a dilutive effect on the Company’s market price. The Company is required to register for re-sale all shares otherwise issuable upon exercise of certain of the above listed warrants. If a registration statement is not declared effective many of the foregoing warrants will become exercisable through a cashless exercise method.
 
Use of Proceeds
 
We will not receive any proceeds from the sale of common stock by the selling securityholders of China Sky One in this offering. However, we will receive proceeds from the exercise of warrants by the selling securityholders. In the extent warrants are exercised, we intend to use the proceeds for general working capital purposes.
 
Risk Factors
 
An investment in the shares involves various risks including, but not limited to, general econ omic and business conditions in China and the competitiveness of the over-the-counter nutritional supplement and the over-the-counter plant and herb-based pharmaceutical and medicinal products industry in China. Specific risk factors can be found commencing page 5.
 
6

 
SUMMARY CONSOLIDATED FINANCIAL DATA
 
The following table sets forth selected consolidated financial data of China Sky One for the years ended December 31, 2007 and 2006. Prior to such time the company was a “blank check” shell company, accordingly earlier financial information about the registrant may not be relevant. The table should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements, including the notes, appearing in elsewhere in this prospectus.

Consolidated Income Statement Data 
 
   
For the Years Ended
December 31,
 
 
 
2007
 
2006
 
Sales
 
$
49,318,308
 
$
19,881,715
 
Cost of goods sold
   
10,939,531
   
5,063,084
 
Research expenses
   
3,158,351
   
2,026,788
 
General & administrative
   
16,163,577
   
10,738,285
 
Depreciation
   
443,063
   
121,522
 
Other income
   
48,889
     
Gain on disposal of asset
         
Interest expense/finance costs
   
(10,557
)
 
(227,857
)
Minority interest
         
Income tax (provision) benefit
   
(3,319,173
)
 
(1,079,764
)
Net income
   
15,332,945
   
624,415
 
Other comprehensive income
   
1,849,724
   
364,565
 
Total comprehensive income
   
17,182,669
   
988,980
 
Basic net income per share
 
$
1.27
 
$
0.05
 
Weighted average basic shares outstanding
   
12,094,949
   
12,031,536
 
Diluted net income per common share
 
$
1.15
 
$
0.05
 
Weighted average diluted shares outstanding
   
13,370,528
   
12,941,283
 
 
Consolidated Balance Sheet Data

   
Year Ended December 31,
 
   
2007
 
2006
 
Total Assets
 
$
37,285,206
 
$
16,681,036
 
Total Current liabilities
   
5,040,393
   
2,370,194
 
Long term debt (1)
             
Minority interest
   
       
Total stockholders equity
   
32,244,813
   
14,310,842
 

7


Quarterly Financial Data for 2007 and 2006

 
 
March 31,
 
June 30,
 
September 30,
 
December 31,
 
Fiscal Year
 
 
 
2007
 
2007
 
2007
 
2007
 
2006
 
Total revenues
 
$
5,179,116
 
$
19,824,363
 
$
36,594,933
 
$
49,318,308
 
$
19,881,715
 
Gross profit
 
$
4,052,421
 
$
15,389,020
 
$
28,490,578
 
$
38,378,777
 
$
14,818,631
 
Gross Margin:
   
78
%
 
78
%
 
77
%
 
78
%
 
75
%
 
                               
Net income
 
$
1,549,321
 
$
5,781,644
 
$
11,227,915
 
$
15,332,945
 
$
624,415
 
Net earnings per common share:
                               
Basic
 
$
0.13
 
$
0.48
 
$
0.93
 
$
1.27
 
$
0.05
 
Diluted
 
$
0.12
 
$
0.46
 
$
0.90
 
$
1.15
 
$
0.05
 
 
[Remainder of Page Intentionally Left Blank]
 
8


RISK FACTORS

Our business and financial condition is subject to numerous and substantial risks including, without limitation, risks relating to our forward looking statements. A description of theses forward looking statements is contained in the forepart of this prospectus and incorporated by reference herein. These risks include those set forth below and elsewhere in this prospectus. Readers are encouraged to review these risks carefully before making any investment decision.  Additional risks and uncertainties not presently foreseeable to us may also impair business operations.   If any of the following risks occur, our business, financial condition or operating results could be materially and adversely affected.  In such case, the trading price of our common stock could decline, and an investor could lose all or part of his investment. Most of the risks set forth below pertain to the business relating to the businesses of our PRC based subsidiaries.

BUSINESS RISKS
 
Certain officers and directors have significant control over our company, and we do not have employment agreements with them.
 
Dr. Liu Yan-qing and Ms. Han Xiao-yan, who are officers and directors of China Sky One, also serve as officers and directors of ACPG and TDR.    Dr. Liu and Ms. Han own, in the aggregate, 50.4% of the issued and outstanding shares of our common stock.   As a result, these shareholders are effectively able to control certain corporate governance matters requiring shareholders’ approval.  Such matters may include transactions in which they have an interest other than as a shareholder of the Company, the approval of significant corporate transactions such as increasing the authorized number of our shares to complete acquisitions or raise capital, if necessary, and any other transactions requiring a majority vote without seeking other shareholders’ approval. These persons also have the ability to control other matters requiring shareholder approval including our election of directors which could result in the entrenchment of management. Dr. Liu has also deposited 3,000,000 shares into escrow which may be released to unaffiliated investors if certain performance thresholds are not met, which would greatly reduce such executive’s financial stake in our company.
 
Additionally, we do not have employment agreements with such management. Accordingly, if any of these persons should leave the company we would have no remedy or protections in place and would not be able to prevent them from competing with us or working for competitors.
 
Our expansion plan may not be successful.
 
Part of our strategy is to grow through increasing the distribution and sales of our products by penetrating existing markets in the PRC and Hong Kong, and entering new geographic markets in the PRC as well as Asia, the United States and other countries.  However, many obstacles to entering such new markets exist, including, but not limited to, international trade and tariff barriers, regulatory constraints, product liability concerns, shipping and delivery costs, costs associated with marketing efforts abroad and maintaining attractive foreign exchange ratios.  Moreover, our expansion strategy may be based on incorrect assumptions and may be flawed, and may even damage our performance, competitive position in the market and ultimately even our ability to survive in the marketplace.  Even if the strategy is correct, we may never be able to successfully implement our strategy. We cannot, therefore, assure shareholders that we will be able to successfully overcome such obstacles and establish our products in any additional markets.  Our inability to implement this growth strategy successfully may have a negative impact on growth, future financial condition, results of operations or cash flows.
 
There are many safety risks involved in our products and services that could expose us to liability or inhibit our ability to secure insurance.
 
Our products and services involve direct or indirect impact on human health and life. The drugs, products and services we manufacture and sell may be flawed and cause dangerous side effects and even fatality in certain cases, and lead to major business losses and legal and other liabilities and damages to our company. In the event that any of our products are alleged to have adverse side effects, we could be subject to product liability claims. In addition to the threat of liability, there may be insurance costs if we enter into certain markets or may not be able to obtain insurance for certain products in some countries. Some distributors may refuse to sell our products in certain countries if they perceive such products to have a high risk or to be uninsurable.

We are highly dependent upon the public perception and quality of our products. Additionally, anti-corruption measures taken by the government to correct corruptive practices in the pharmaceutical industry could adversely affect our sales and reputation.
 
We are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar products distributed by other companies. Thus, the mere publication of reports asserting that such products may be harmful could have a material adverse effect on our business, regardless of whether these reports are scientifically supported.
 
 The government has recently taken anti-corruption measures to correct corrupt practices. In the pharmaceutical industry, such practices include, among others, acceptance of kickbacks, bribery or other illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical distributors in connection with the prescription of a certain drug. Substantially all of our sales to our ultimate customers are conducted through third-party distributors. We have no control over our third-party distributors, who may engage in corrupt practices to promote our products. While we maintain strict anti-corruption policies applicable to our internal sales force and third-party distributors, these policies may not be effective. If any of our third-party distributors engage in such practices and the government takes enforcement action, our products may be seized and our own practices, and involvement in the distributors’ practices may be investigated. If this occurs, our sales and reputation may be materially and adversely affected.
 
9

 
Our success will depend on our research and the ability to develop new products.
 
Our growth depends on our ability to consistently discover, develop and commercialize new products and find new and improve on existing technologies, platforms and products.  As such, if we fail to make sufficient investments in research, to be attentive to consumer needs, or fail to focus on the most advanced technologies, our current and future products could be surpassed by more effective or advanced products of other companies.
 
Significant competition from existing and new entities could adversely affect revenues and profitability. 
 
We compete with other companies, many of which are offering and/or developing, or can be expected to develop and offer, products similar to ours.  Our market is a large market with many competitors.  Many of our competitors are more established than we are, and have significantly greater financial, technical, marketing and other resources than our company.  Some of our competitors have greater name recognition and a larger customer base.  These competitors may be able to respond more quickly to new or changing opportunities and customer requirements and may be able to undertake more extensive promotional activities, offer more attractive terms to customers, and adopt more aggressive pricing policies.   We cannot assure investors that we will be able to compete effectively with current or future competitors or that the competitive pressures we face will not harm our business.

We may not be able to obtain sufficient financing, and may not be able to develop our product candidates. 
 
We may need to incur debt or issue equity in order to fund research and other expenditures as well as to make acquisitions and other investments. We cannot assure you that debt or equity financing will be available to us on acceptable terms or at all. If we cannot or are limited in the ability to incur debt, issue equity or enter in strategic collaborations, we may be unable to fund discovery and development of our product candidates, address gaps in our product offerings or improve our technologies.
 
We anticipate that we will need to raise substantial amounts of money to fund a variety of future activities integral to the development of our business, which may include but are not limited to the following:
 
 
·
obtaining regulatory approval for our products and conducting research and development to successfully develop our stem cell and other technologies,
     
 
·
filing and prosecuting patent applications and defending and assessing patents to protect our technologies,
     
 
·
retaining qualified employees, particularly in light of intense competition for qualified scientists,
     
 
·
manufacturing products ourselves or through third parties,
     
 
·
marketing our products, either through building our own sales and distribution capabilities or relying on third parties, and
     
 
·
acquiring new technologies, licenses or products.
 
We cannot assure you that any needed financing will be available to us on acceptable terms or at all. If we cannot obtain additional financing in the future, our operations may be restricted and we may ultimately be unable to continue to develop and potentially commercialize our product candidates.

We are subject to market and channel risks.

Over 75% of our sales are made in the PRC, where we primarily sell our products through drug chain stores.  Because of this, we are dependent to a large degree upon the success of our PRC based distribution channel as well as the success of specific retailers in the distribution channel. Many of the drug stores are individual stores or very small chains, and only a few are large chain drug stores.  We rely on these distribution channels to purchase, market, and sell our products.  Our success is dependent, to a large degree, on the growth and success of the drug stores, which may be outside our control.  There can be no assurance that the drug store distribution channels will be able to grow or prosper as it faces price and service pressure from other channels, including the mass market.  There can be no assurance that retailers in the drug store distribution channel, in the aggregate, will respond or continue to respond to our marketing commitment in these channels.
 
We may have difficulty in defending intellectual property rights from infringement.
 
Our TCM products are generally not protected by patents but by trade secrets. Certain TCM license agreements are made on a non-exclusive basis. Our success depends, in large part, on our ability to protect current and future technologies and products and to defend our intellectual property rights.  If we fail to protect our intellectual property adequately, competitors may manufacture and market similar products.  We continually file, patent applications seeking to protect newly developed technologies and products in various countries, particularly in the PRC.  Some patent applications in the PRC are maintained in secrecy until the patent is issued.  Because the publication of discoveries tends to follow their actual discovery by many months, we may not be the first to invent, or file patent applications on any of its discoveries.  Patents may not be issued with respect to any of our patent applications and existing or future patents issued to or licensed by us may not provide competitive advantages for its products.  Patents that are issued may be challenged, invalidated or circumvented by competitors.  Furthermore, our patent rights may not prevent our competitors from developing, using or commercializing products that are similar or functionally equivalent to our products.
 
10

 
To the extent that we market products in other countries, we may have to take additional action to protect our intellectual property.   The measures we take to protect our proprietary rights may be inadequate, and we cannot provide any assurance that our competitors will not independently develop formulations and processes that are substantially equivalent or superior to our products or copy our products.

We also rely on trade secrets, non-patented proprietary expertise and continuing technological innovation that we seek to protect, in part, by entering into confidentiality agreements with licensees, suppliers, employees and consultants.  These agreements may be breached and there may not be adequate remedies in the event of a breach.  Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements.  Moreover, trade secrets and proprietary technology may otherwise become known or be independently developed by competitors.  If patents are not issued with respect to products arising from research, we may not be able to maintain the confidentiality of information relating to these products.
 
We will be subject to risks relating to third parties that may claim that we infringe on their proprietary rights and may prevent us from manufacturing and selling certain of our products.
 
There has been substantial litigation in the pharmaceutical and nutraceutical industries with respect to the manufacturing, use and sale of new products. These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties.  We may be required to commence or defend against charges relating to the infringement of patent or proprietary rights.  Any such litigation could involve or result in:
 
·
the incurrence of substantial expense, even if we are successful in the litigation;
 
·
a diversion of significant time and effort of technical and management personnel;
 
·
the loss of our rights to develop or make certain products; and
 
·
the payment of substantial monetary damages or royalties in order to license proprietary rights from third parties.
 
Although patent and intellectual property disputes within these industries have often been settled through licensing or similar arrangements, costs associated with these arrangements may be substantial and could include the long-term payment of royalties. These arrangements may be investigated by regulatory agencies and, if improper, may be invalidated. Also, the required licenses may not be made available to our company on acceptable terms.  Accordingly, an adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent our company from manufacturing and selling some of our products or increase costs to market these products.
 
In addition, when seeking regulatory approval for some of our products, we are required to certify to regulatory authorities, including the SFDA that such products do not infringe upon third party patent rights.  Filing a certification against a patent gives the patent holder the right to bring a patent infringement lawsuit against our company.  Any lawsuit would delay regulatory approval by the SFDA.  A claim of infringement and the resulting delay could result in substantial expenses and even prevent us from manufacturing and selling certain of our products.
 
The launch of a product prior to a final court decision or the expiration of a patent held by a third party may result in substantial damages to our company.  Depending upon the circumstances, a court may award the patent holder damages equal to three times their loss of income.  If our company is found to infringe a patent held by a third party and become subject to such treble damages, these damages could have a material adverse effect on our results of operations and financial condition.

Our failure to comply with accounting policies and regulations in making reasonable estimates and judgments could negatively impact our financial position and results of operation. 
 
We will be subject to critical accounting policies and actual results may vary from estimates.  We have followed, and will continue to follow, generally accepted accounting principles for the United States in preparing financial statements. As part of this work, we must make many estimates and judgments concerning future events. These affect the value of the assets and liabilities, contingent assets and liabilities, and revenue and expenses reported in such financial statements.  We believe that these estimates and judgments are reasonable, and we have made them in accordance with accounting policies based on information available at the time. However, actual results could differ from estimates, and this could require us to record adjustments to expenses or revenues that could be material to our financial position and results of operations in the future.
 
11

 
 Our business is subject to many governmental regulatory and policy risks.
 
Our business must be conducted in compliance with various government regulations and in particular, the PRC State Food and Drug Administration (“SFDA”) regulations. Government regulations may have material impact on our operations, increase costs and could prevent or delay the manufacturing and selling of our products.  Research, development, testing, manufacturing and marketing activities are subject to various governmental regulations in China, including health and drug regulations.  Government regulations, among other things, cover the inspection of and controls over testing, manufacturing, safety and environmental considerations, efficacy, labeling, advertising, promotion, record keeping and sale and distribution of pharmaceutical products.  We will not be able to license, manufacture, sell and distribute the vast majority of its products without a proper approval from government agencies and in particular the SFDA.  There is no assurance that we will obtain such approvals.
 
In addition, delays or rejections may be encountered based upon additional government regulation from future legislation, administrative action or changes in governmental policy and interpretation during the period of product development and product assessment.  Although we have, so far, obtained the rights to sell our products in the PRC, we may not continue to receive and maintain regulatory approvals for the sales of these products.  Our marketing activities are also subject to government regulations with respect to the prices that it intends to charge or any other marketing and promotional related activities.  Government regulations may substantially increase the costs for developing, licensing, manufacturing and selling products, impacting negatively our operations, revenue, income and cash flow. For more specific risks relating to doing business in the PRC see “China Related Risks” below.
 
There could be changes in government regulations towards the pharmaceutical and nutraceutical industries that may adversely affect our business.
 
The manufacture and sale of pharmaceutical and nutraceutical products in the PRC is heavily regulated by many state, provincial and local authorities.  These regulations significantly increased the difficulty and costs involved in obtaining and maintaining regulatory approvals for marketing new and existing products.  Our future growth and profitability depends to a large extent on our ability to obtain regulatory approvals.
 
The SFDA of China implemented new guidelines for licensing of pharmaceutical products. All existing manufacturers with licenses, which are currently valid under the previous guidelines, were required to apply for the Good Manufacturing Practices “GMP” certifications by June 30, 2004, and to receive approvals by December 31, 2004.  We received certifications for our current products.  However, should we fail to maintain the GMP certifications under the new guidelines in the future, or for new products, our businesses would be materially and adversely affected.
 
Moreover, the laws and regulations regarding acquisitions of the pharmaceutical and nutraceutical industries in the PRC may also change and may significantly impact our ability to grow through acquisitions. For more specific risks relating to doing business in the PRC see “China Related Risks” below.
 
We need to manage growth in operations to maximize our potential growth and achieve our expected revenues.
 
Our success depends on our ability to achieve continued growth.  In order to maximize potential growth in current and potential markets, we believe that we must expand our manufacturing and marketing operations.  This expansion will place a significant strain on management and operational, accounting and information systems and will require substantial additional capital.  We will need to continue to improve financial controls, operating procedures, and management information systems if and as we grow.  We will also need to effectively train, motivate, and manage our employees.  A failure to manage our growth could disrupt operations and ultimately prevent us from generating the revenues we expect.
 
International operations require our company to comply with a number of U.S. and international regulations.  
 
We are required to comply with a number of international regulations in countries outside of the United States.  In addition, we must comply with the Foreign Corrupt Practices Act, or FCPA, which prohibits U.S. companies or their agents and employees from providing anything of value to a foreign official for the purposes of influencing any act or decision of these individuals in their official capacity to help obtain or retain business, direct business to any person or corporate entity or obtain any unfair advantage.  Any failure to adopt appropriate compliance procedures and ensure that our employees and agents comply with the FCPA and applicable laws and regulations in foreign jurisdictions could result in substantial penalties and/or restrictions in our ability to conduct business in certain foreign jurisdictions. The U.S. Department of The Treasury's Office of Foreign Asset Control, or OFAC, administers and enforces economic and trade sanctions against targeted foreign countries, entities and individuals based on U.S. foreign policy and national security goals.  As a result, we are restricted from entering into transactions with certain targeted foreign countries, entities and individuals except as permitted by OFAC which may reduce our future growth.
 
We may incur significant costs to ensure compliance with U.S. corporate governance and accounting requirements.  
 
We are a public reporting company, and, as such, we will incur significant costs associated with public company reporting requirements, costs associated with newly applicable corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the U.S. Securities and Exchange Commission.  We also will be deemed an “Accelerated Filer” for SEC reporting purposes, for the first time, which will require our preparation and filing of more detailed reports on a quicker schedule, which we have never done before. All of these applicable rules and regulations can be expected to increase legal and financial compliance costs and to make some activities more time consuming and costly.  Management also expects that these applicable rules and regulations may make it more difficult and more expensive to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for our company to attract and retain qualified individuals to serve on our board of directors or as executive officers.
 
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We may have difficulty raising necessary capital to fund operations as a result of market price volatility for our shares of common stock.
 
In recent years, the securities markets in the United States have experienced a high level of price and volume volatility, and the market price of securities of many companies have experienced wide fluctuations that have not necessarily been related to the operations, performances, underlying asset values or prospects of such companies.  For these reasons, our shares of common stock can also be expected to be subject to volatility resulting from purely market forces over which we will have no control.  If our business development plans are successful, we may require additional financing to continue to develop and exploit existing and new technologies and to expand into new markets.  The exploitation of existing and new technologies may, therefore, be dependent upon our ability to obtain financing through debt and equity or other means.
 
 We are obligated to indemnify our officers and directors for certain losses they suffer. 
 
To the fullest extent permitted by Chapter 78 of the Nevada Revised Statues, we may, if and to the extent authorized by our board of directors, indemnify our officers and any other persons who we have power to indemnify against liability, reasonable expense or other matter whatsoever. If we are required to indemnify any persons under this policy, we may have to pay indemnity in a substantial amount which we may be unable to recover at all.

CHINA RELATED RISKS
 
Our business will be affected by the government regulation and Chinese economic environment because most of our sales will be in the China market.
 
The manufacture and sale of pharmaceutical products in China is heavily regulated by many state, provincial and local authorities. The SFDA of China requires pharmaceutical manufacturers to obtain Good Manufacturing Practices, or GMP, certifications. We currently have the certifications needed for our current operations. However, should we fail to receive or maintain the GMP certifications in the future, we would no longer be able to manufacture pharmaceuticals in China, and our businesses would be materially and adversely affected. These regulations significantly increase the difficulty and costs involved in obtaining and maintaining regulatory approvals for marketing new and existing products. Our future growth and profitability depend to a large extent on our ability to obtain regulatory approvals. Additionally, the law could change so as to prohibit the use of certain pharmaceuticals. If one of our products becomes prohibited, this change would cease the productivity of that product. The China National Development and Reform Commission, or CNDRC, has recently implemented price adjustments on many marketed pharmaceutical products. We have no control over such governmental policies, which may impact the pricing and profitability of our products.
 
Although we have started exporting products to other countries, most of our sales are in the PRC and Hong Kong.  It is anticipated that our products in the PRC will continue to represent a significant portion of sales in the near future.  As a result of our reliance on the PRC markets, our operating results and financial performance could be affected by any adverse changes in economic, political and social conditions in the PRC.

The modernization of regulations for the pharmaceutical industry is relatively new in the PRC, and the manner and extent to which it is regulated will continue to evolve.   As a pharmaceutical company, we are subject to the Pharmaceutical Administrative Law, which governs the licensing, manufacture, marketing and distribution of pharmaceutical products in the PRC, and sets penalty provisions for violations of provisions of the Pharmaceutical Administrative Law.  In addition as a  “Foreign Owned Enterprise,” we will be subject to the Foreign Company provisions of the Company Law of the PRC.  Changes in these laws or new interpretations of existing laws may have a significant impact our methods and our cost of doing business.  For example, if legislative proposals for pharmaceutical product pricing, reimbursement levels, approval criteria or manufacturing requirements should be proposed and adopted, such new legislation or regulatory requirements may have a material adverse effect on our financial condition, results of operations or cash flows.  In addition, we are subject to varying degrees of regulation and licensing by governmental agencies in China. At this time, we are unaware of any China legislative proposals that could adversely affect our business. There can be no assurance that future regulatory, judicial and legislative changes will not have a material adverse effect on our operations, that regulators or third parties will not raise material issues with regard to compliance or non-compliance with applicable laws or regulations, or that any changes in applicable laws or regulations will not have a material adverse effect on our business.
 
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Certain political and economic considerations relating to China could adversely affect our company.
 
China is transitioning from a planned economy to a market economy. While the PRC government has pursued economic reforms since its adoption of the open-door policy in 1978, a large portion of the Chinese economy is still operating under five-year plans and annual state plans. Through these plans and other economic measures, such as control on foreign exchange, taxation and restrictions on foreign participation in the domestic market of various industries, the PRC government exerts considerable direct and indirect influence on the economy. Many of the economic reforms carried out by the PRC government are unprecedented or experimental, and are expected to be refined and improved. Other political, economic and social factors can also lead to further readjustment of such reforms. This refining and readjustment process may not necessarily have a positive effect on our operations or future business development. Our operating results may be adversely affected by changes in China’s economic and social conditions as well as by changes in the policies of the PRC government, such as changes in laws and regulations, or the official interpretation thereof, which may be introduced to control inflation, changes in the interest rate or method of taxation, and the imposition of additional restrictions on currency conversion.
 
Accordingly, government actions in the future, including any decision not to continue to support recent economic reforms and to return to a more centrally planned economy or regional or local variations in the implementation of economic policies, could have a significant effect on economic conditions in China or particular regions thereof, and could require us to divest ourselves of any interest we then hold in Chinese properties or joint ventures.
 
There are risks inherent in doing business in China.
 
The PRC is a developing country with a young market economic system overshadowed by the state under heavy regulation and scrutiny. Its political and economic systems are very different from the more developed countries.  China also faces many social, economic and political challenges that may produce major shocks and instabilities and even crises, in both its domestic arena and in its relationship with other countries, including but not limited to the United States. Such shocks, instabilities and crises may in turn significantly and adversely affect our performance.
 
The recent nature and uncertain application of many PRC laws applicable to our company create an uncertain environment for business operations and they could have a negative effect on our business and operations.
 
The PRC legal system is a civil law system. Unlike the common law system, the civil law system is based on written statutes in which decided legal cases have little value as precedents. In 1979, the PRC began to promulgate a comprehensive system of laws and has since introduced many laws and regulations to provide general guidance on economic and business practices in the PRC and to regulate foreign investment. Progress has been made in the promulgation of laws and regulations dealing with economic matters such as corporate organization and governance, foreign investment, commerce, taxation and trade. The promulgation of new laws, changes of existing laws and the abrogation of local regulations by national laws could have a negative impact on our business, business prospects and operations.  In addition, as these laws, regulations and legal requirements are relatively recent, their interpretation and enforcement involve significant uncertainty.
 
It may be difficult to effect service of process and enforcement of legal judgments upon our company and its officers and directors because they reside outside the United States.
 
As our operations are presently based in the PRC and our directors and officers reside in the PRC, service of process on our company and such directors and officers may be difficult to effect within the United States.  Also, substantially all of our assets are located in the PRC and any judgment obtained in the United States against our company may not be enforceable outside the United States.

Our business may be affected by unexpected changes in regulatory requirements in the jurisdictions in which we operate.

Our company, and its subsidiaries, are subject to many general regulations governing business entities and their behavior in China and in other jurisdictions in which we and our subsidiaries have, or plan to have, operations and market products.  In particular, we are subject to laws and regulations covering food, dietary supplements and pharmaceutical products.  Such regulations typically deal with licensing, approvals and permits.  Any change in product licensing may make our products more or less available on the market.  Such changes may have a positive or negative impact on the sale of our products and may directly impact the associated costs in compliance and our operational and financial viability.  Such regulatory environment also covers any existing or potential trade barriers in the form of import tariff and taxes that may make it difficult for us to import our products to certain countries and regions, such as Hong Kong, which would limit its international expansion.
 
We may have difficulty attracting talent in foreign countries.
 
Currently, over 75% of our sales are in the PRC and in Hong Kong.  We are in the process of attempting to establish marketing and sales presence in the United States and other countries.  We expect to establish an office in the United States for investor relations.  In the future, we may explore expanding its operations in the United States, as well as other countries throughout the world.  Upon effecting any such expansion, we may not be able to identify and retain qualified personnel due to its lack of understanding of different cultures and lack of local contacts. This may impede international expansion.
 
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Currency conversion and exchange rate volatility could adversely affect our financial condition, by making acquisitions in China or of Chinese products ore expensive.
 
The PRC government imposes control over the conversion of RMB into foreign currencies. Under the current unified floating exchange rate system, the People’s Bank of China publishes an exchange rate, referred to as the PBOC exchange rate, based on the previous day’s dealings in the inter-bank foreign exchange market. Financial institutions authorized to deal in foreign currency may enter into foreign exchange transactions at exchange rates within an authorized range above or below the PBOC exchange rate according to market conditions.
 
Pursuant to the Foreign Exchange Control Regulations of the PRC issued by the State Council which came into effect on April 1, 1996, and the Regulations on the Administration of Foreign Exchange Settlement, Sale and Payment of the PRC which came into effect on July 1, 1996, regarding foreign exchange control, conversion of RMB into foreign exchange by Foreign Investment Enterprises, or FIE’s, for use on current account items, including the distribution of dividends and profits to foreign investors, is permissible.  FIEs are permitted to convert their after-tax dividends and profits to foreign exchange and remit such foreign exchange to their foreign exchange bank accounts in the PRC.
 
Conversion of RMB into foreign currencies for capital account items, including direct investment, loans, and security investment, is still subject to certain restrictions. On January 14, 1997, the State Council amended the Foreign Exchange Control Regulations and added, among other things, an important provision, which provides that the PRC government shall not impose restrictions on recurring international payments and transfers under current account items. These rules are subject to change.

Enterprises in the PRC (including FIEs) which require foreign exchange for transactions relating to current account items, may, without approval of the State Administration of Foreign Exchange, or SAFE, effect payment from their foreign exchange account or convert and pay at the designated foreign exchange banks by providing valid receipts and proofs.

Convertibility of foreign exchange in respect of capital account items, such as direct investment and capital contribution, is still subject to certain restrictions, and prior approval from the SAFE or its relevant branches must be sought.

Our company is a FIE to which the Foreign Exchange Control Regulations are applicable. There can be no assurance that we will be able to obtain sufficient foreign exchange to pay dividends or satisfy other foreign exchange requirements in the future.

Since 1994, the exchange rate for RMB against the United States dollars has remained relatively stable, most of the time in the region of approximately RMB8.00 to US$1.00. However, in 2005, the Chinese government announced that would begin pegging the exchange rate of the Chinese RMB against a number of currencies, rather than just the U.S. dollar.  Currently, exchange rates are approximately RMB 7.006 to US$1.00 resulting in the increase in price of Chinese products to U.S purchasers. As our operations are primarily in China, any significant revaluation of the Chinese RMB may materially and adversely affect cash flows, revenues and financial condition.  For example, to the extent that we need to convert United States dollars into Chinese RMB for operations, appreciation of this currency against the United States dollar could have a material adverse effect on our business, financial condition and results of operations.  Conversely, if we decide to convert Chinese RMB into United States dollars for other business purposes and the United States dollar appreciates against this currency, the United States dollar equivalent of the Chinese RMB that we convert would be reduced.

We are required to be in compliance with the registered capital requirements of the PRC.
 
Under the Company Law of the PRC, our company will be required to contribute a certain amount of  “registered capital” to our wholly owned subsidiary.  By law, our subsidiaries are required to contribute at least 10% of after tax net income (as determined in accordance with Chinese GAAP) into a statutory surplus reserve until the reserve is equal to 50% of the Company and its subsidiaries’ registered capital, and between 5% and 10% of its after tax net income, as determined by our board of directors, into a public welfare fund. These reserve funds are recorded as part of shareholders’ equity but are not available for distribution to shareholders other than in the case of liquidation.  As a result of this requirement, the amount of net income available for distribution to shareholders will be limited.
 
Since most of our assets are located in the PRC, any dividends or proceeds from liquidation are subject to the approval of the relevant PRC government agencies. We are not likely to declare dividends in the near future and would need regulatory approval to do so.
 
Because our assets are predominantly located inside the PRC, we will be subject to the law of the PRC in determining dividends. Under the laws governing foreign invested enterprises in the PRC, dividend distribution and liquidation are allowed but subject to special procedures under the relevant laws and rules.  Any dividend payment will be subject to the decision of the board of directors and subject to foreign exchange rules governing such repatriation. Any liquidation is subject to both the relevant government agency’s approval and supervision as well the foreign exchange control.   This may generate additional risk for investors in case of dividend payment and liquidation.
 
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RISKS RELATED TO COMMON STOCK

There are substantial risks of lack of liquidity and volatility risks.
 
Our common stock is quoted in the OTC Bulletin Board market under the symbol “CSKI.”  The liquidity of our common stock may be very limited and affected by its limited trading market. The OTC Bulletin Board market is an inter-dealer market much less regulated than the major exchanges, and is subject to abuses and volatilities and shorting. There is currently no broadly followed and established trading market for our common stock. An established trading market may never develop or be maintained. Active trading markets generally result in lower price volatility and more efficient execution of buy and sell orders.  Absence of an active trading market reduces the liquidity of the shares traded there.
 
The trading volume of our common stock may be limited and sporadic.  As a result of such trading activity, the quoted price for our common stock on the OTC Bulletin Board may not necessarily be a reliable indicator of its fair market value.  In addition, if our shares of common stock cease to be quoted, holders would find it more difficult to dispose of, or to obtain accurate quotations as to the market value of, our common stock and as a result, the market value of our common stock likely would decline.
 
We do not plan to declare or pay any dividends to our shareholders in the near future and would need regulatory approval to do so.
 
We have not declared any dividends in the past, and we do not intend to distribute dividends in the near future. The declaration, payment and amount of any future dividends will be made at the discretion of the board of directors and subject to PRC law, and will depend upon, among other things, the results of operations, cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and if dividends are paid, there is no assurance with respect to the amount of any such dividend.

Sales of our common stock may have an adverse effect on the market price of our common stock. Additionally, we may issue shares upon exercise of outstanding warrants that are exercisable at prices that are below current market prices which will be dilutive to the common stock.

As of March 20, 2008, there were 14,852,214 shares of common stock outstanding, which includes 2,500,000 shares of our common stock we sold in January 2008 private offering, many of which will become freely transferable under Rule 144 in July 2008 as well as 100,000 shares issued in connection with the recent exercise of warrants at $3.00 per share and 260,835 callable warrants exercised at $3.50 per share all of which are required to be registered, along with other shares underlying warrants listed below, in this registration statement. The sale of these shares may have an adverse effect on the market price for our common stock.

The exercise of options and warrants at prices below market price of our common stock could adversely affect the price of our common stock and on our ability to obtain future private or public financings. Additional dilution may result from the issuance of shares of our capital stock in connection with outstanding warrants or shares issued in connection with financing or other share for service arrangements.

          Specifically, the following shares underlying warrants are outstanding which include:

 
·
1,000,000 shares (which are not being registered herein) issuable upon exercise of warrants exercisable at $2.00 per share via cashless exercise, and expiring July 31, 2009, originally issued to American Eastern Group, Inc. (500,000 warrants) and Schenzen DRB (500,000 warrants) as partial consideration for consulting and investment banking services relating to our October 2006 offering and reverse merger,
     
 
·
750,000 shares issuable upon exercise of Class A Warrants exercisable at $12.50 per share, issued to investors in connection with our private offering in January 2008, exercisable between July 31, 2008 and July 31, 2011,
     
 
·
239,168 shares issuable upon exercise of callable warrants exercisable at $3.50 per share (originally, 500,000 callable warrants, many of which have been exercised the shares of which are being registered hereby), expiring October 10, 2008 and held by certain investors in our private offering of securities in October of 2006,
     
 
·
50,000 shares of common stock issuable upon exercise of warrants exercisable at $3.00 per share, issued to Mr. Jack M. Gertino, a former executive of the Company, and expiring December 23, 2008, and
     
 
·
50,000 shares of common stock issuable upon exercise of warrants exercisable at $3.50 per share, issued to American Eastern Securities, Inc. (and its assigns), and expiring on October 10, 2008.
 
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The Company is required to register for re-sale and is registering for resale hereby, all of the above listed common stock. If a registration statement is not declared effective many of the foregoing warrants will become exercisable through a cashless exercise method.

Certain Protective Provisions Relating to 2,500,000 shares issued in our January 2008 private offering may have an adverse effect on the price of our common stock.
 
In addition to the above mentioned registration rights, holders of the 2,500,000 shares of common stock acquired in our recently completed private offering (January 2008) have certain put rights and rights to receive 3,000,000 additional shares from a key shareholder, as well as additional shares from us, in the event that certain earnings thresholds are not met or if we issue low priced securities. Specifically, these investors have:
 
 
·
The right to receive additional shares from us in the event that we issue shares (or convertible securities or warrants convertible into or exercisable for common stock) prior to January 31, 2009 at per share price (or conversion or exercise price) of less than $10.00, in such amount so as to reduce the average price paid by such shareholder to the price per share being paid by the new investors,
 
 
·
The right to receive up to 3,000,000 shares deposited into escrow by our principal shareholder, in the event that the Company fails to attain Earnings Per Share, as adjusted of at least (i) $1.05 per share for fiscal year ended December 31, 2007 based on fully diluted shares outstanding before the January 2008 offering (an aggregate of 13,907,696), and/or (ii) $1.75 per share for fiscal year ending December 31, 2008 based on fully diluted shares outstanding after the January 2008 Offering (an aggregate of 16,907,696 shares). While the Company has satisfied the criterion of (i) above for 2007, no assurance can be made that we will satisfy our earnings goal next year.

The occurrence of either of the above would result in the issuance of additional shares to these investors and would have a material adverse effect on the market price or liquidity of our common stock. The foregoing could also result in a decrease in our principal shareholder’s financial stake in the company.

FORWARD-LOOKING STATEMENTS
 
This prospectus contains forward-looking statements that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as “may”, “expect”, “plans”, “intends”, “anticipate”, “believe”, “estimate” and “continue” or similar words and are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should read statements that contain these words carefully because they discuss our future expectations, contain projections of our future results of operations or of our financial condition or state other “forward-looking” information. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control. The factors listed above in the section captioned “Risk Factors”, as well as any cautionary language in this prospectus, provide examples of risks, uncertainties and events that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Before you invest in the common stock, you should be aware that the occurrence of the events described as risk factors and elsewhere in this prospectus could have a material adverse effect on our business, operating results and financial condition.
 
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BUSINESS

We are engaged, through our China based indirect subsidiaries described below, in the development, manufacture, marketing and sale of over-the-counter, branded nutritional supplements and over-the-counter plant and herb based pharmaceutical and medicinal products.   Our principal products are external use Traditional Chinese Herbal Remedies/ Medicines commonly referred to in the industry as “TCM.” We have evolved into an integrated manufacturer, marketer and distributor of external use Chinese medicine products sold primarily in China and through Chinese domestic pharmaceutical chains and have been expanding our worldwide sales effort as well.  We sell both our own manufactured products, as well as medicinal and pharmaceutical products manufactured by others in China.   
 
Corporate History
 
China Sky One Medical, Inc. (“China Sky One”) , is a Nevada corporation formed on February 7, 1986, formerly known as Comet Technologies, Inc. (“Comet”).  On July 26, 2006, after our acquisition of a China based nutritional supplements business, we changed our name to “China Sky One Medical, Inc.”

ACPG, our non operating United States holding company subsidiary, was incorporated on December 16, 2003, in the State of California, under the name “QQ Group, Inc.” It changed its name to “American California Pharmaceutical Group, Inc.” in anticipation of the Stock Exchange Agreement with China Sky One (then known as “Comet Technologies, Inc.”) and TDR, described herein. On December 8, 2005, ACPG completed a stock exchange transaction with TDR a PRC based operating company and TDR’s subsidiaries (the “TDR Acquisition”), each of which were fully operating companies in the PRC. Under the terms of the agreement, ACPG exchanged 100% of its issued and outstanding common stock for 100% of the capital stock of TDR and its subsidiaries, described below.

Thereafter, on May 11, 2006, ACPG entered into a Stock Exchange Agreement (the “Exchange Agreement”) with the shareholders of China Sky One. The terms of the Exchange Agreement were consummated and the acquisition was completed on May 30, 2006. As a result of the transaction, the Company issued a total of 10,193,377 shares of its common voting stock to the stockholders of ACPG, in exchange for 100% of the capital stock of ACPG resulting in ACPG becoming our wholly-owned subsidiary.

TDR, formerly known as “Harbin City Tian Di Ren Medical Co.,” was originally formed in 1994 and maintained its principal executive office in Harbin City of Heilongjiang Province, in the PRC. TDR was reorganized and incorporated as a limited liability company on December 29, 2000, under the “Corporation Laws and Regulations” of the PRC. At the time of the TDR Acquisition by ACPG in December of 2005, TDR had two wholly-owned subsidiaries, Harbin First Bio-Engineering Company Limited and Kangxi Medical Care Product Factory, until July, 2006, when the two were merged, with Harbin First Bio-Engineering Company Limited as the surviving subsidiary of TDR.

We have also recently organized Harbin Tian Qing Biotech Application Company as a wholly-owned PRC subsidiary of TDR, to conduct research and development in the areas of tissue and stem cell banks, which is described in more detail below.   

On April 3, 2008, TDR completed an acquisition pursuant to an Equity Transfer Agreement dated February 22, 2008, between TDR and Heilongjiang Tianlong Pharmaceutical, Inc., a corporation with a multitude of SFDA approved medicines and new medicine applications, organized under the laws of the PRC (“Heilongjiang”), which is in the business of manufacturing external-use pharmaceuticals. Our TDR subsidiary previously acquired the Beijing sales office of Heilongjiang in mid 2006. Pursuant to the Equity Transfer Agreement, TDR acquired 100% of the issued and outstanding capital stock of Heilongjiang from Heilongjiang’s sole stockholder Wu Jiechen, a resident of China, in consideration for an aggregate purchase price of approximately $8,300,000, consisting of (i) approximately $8,000,000 in cash, and (ii) approximately $300,000 of shares of common stock (24,809 shares, $.001 par value per share) of the Registrant. The seller had no material relationship with the Registrant or any of its affiliates, or any director or officer of the registrant, or any associate of any such director or officer. Additional information relating to this entity can be found elsewhere in this “Business” section and in “Recent Developments” at the end of this section below.

Principal Products and Markets

We are engaged, through TDR and its respective subsidiaries in the PRC, in the development, manufacture, marketing and sale of over-the-counter, branded nutritional supplements and over-the-counter plant and herb based pharmaceutical and medicinal products.   We have evolved into an integrated manufacturer, marketer and distributor of external use Chinese medicine products sold primarily to and through China domestic pharmaceutical chains.  The Company sells both its own manufactured products, and medicinal and pharmaceutical products manufactured by others in the PRC.   
 
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Our manufacturing and sales facilities are in the City of Harbin, Heilongjiang Province and we have sales offices in Beijing.  
 
Our principal products are external use Traditional Chinese Herbal Remedies/ Medicines (“TCM”). Using various formulas, we produce a number of TCM products with several forms of delivery including creams and ointments, powders, sprays, various medicated skin patch products, and herbs believed to have complimentary effects. We intend to concentrate many of our efforts during the next several years on development, production and sales of TCM products and biological test kits and in particular, tissue and our stem cell research as described more fully below.

Our principal operations are in China, where TDR and its subsidiaries have manufacturing facilities and sales distribution covering most of China and the Hong Kong Special Administration Region.   Our overall revenues in 2007 was $49,318,308, most of which was from sales in China, of which, export sales for our main countries of export (in order of revenues during the year ended 2007) were as follows:

 
  2007 Revenues
 
Malaysia
   
93,016,227 RMB
 
United Kingdom
   
540,364 RMB
 
Hong Kong
   
319,064 RMB,
 
United Arab Emirates
   
46,215 RMB
 
United States
   
45,884 RMB
 
Russia
   
20,160 RMB
 
Sweden
   
4,458 RMB
 
Ireland
   
3,346 RMB
 

          TDR has also established several long-term relationships with well-known universities and enterprises in the PRC, as described below under “Current Research and Development.”  Through these relationships, we hope to develop a number of additional products that we will be able to manufacture and market both in the PRC and in other countries.  
Below is a chart depicting the corporate organization of the Company and all related subsidiaries.
 
graph
 
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SFDA Licenses

The State Food and Drug Administration of the government of Heilongjiang, China (“SFDA”) issues the licenses and petitions for permission to manufacture and market pharmaceutical products in the PRC.  Our licenses relate primarily to medical machine producing licenses which are needed mainly for topical products, ointments and external test kits. TCM products also require a permit for sales, which permits are generally granted on a non-exclusive basis for four to five years depending on the TCM. TDR has been granted 11 product licenses and permits, inclusive of our recently approved Cardiac Arrest Early Examination and kidney disease testing kits, which have allowed TDR to commercialize a total of 38 products. TDR is undertaking efforts to develop a series of 8 new products, and is planning to register these products with the SFDA over the next 5 years.   TDR has also registered 7 patents with the State Intellectual Property Rights Bureau of the PRC, which includes packing design patents as well as product ingredients patents.  TDR plans to continue registering patents resulting from its ongoing product research and development.

In addition to the above, as a result of the acquisition by TDR of Heilongjiang in April of 2008,  TDR acquired all of Heilongjiang’s assets, which included, among other things, sixty-nine (69) SFDA-approved medicines, and an additional thirty-eight (38) new medicines, which have been submitted for approval to the State Food and Drug Administration of China (SFDA).

Our TDR Subsidiary Owns the Following Subsidiaries in China

Harbin Bio-Engineering; Enzyme Immunity and Colloid Gold Production

Harbin First Bio-Engineering Company Limited (often referred to herein as “Harbin Bio-Engineering”), was formed in Heilongjiang Province, in the PRC by TDR as its wholly owned subsidiary, on September 26, 2003 with an authorized capital of $241,546 (RMB 2 million).  Harbin Bio-Engineering focuses on research and development of the use of natural medicinal plants and biological technology products, such as Endothelin-1. Harbin Bio-Engineering is one of the first companies in Heilongjiang Province conducting research and development of high technology biological products.  Harbin Bio-Engineering has two production lines:  an enzyme immunity reagent kit production line, and a colloid gold production line.  Harbin Bio-Engineering officially put its facility into production on July 21, 2006.  

Kangxi Medical; Topical Applications

Kangxi Medical Care Product Factory (referred to herein as “Kangxi Medical”) was formed on July 20, 2001, in the City of Harbin, Heilongjiang Province, in the PRC, with an authorized capital of $60,386 (RMB 500,000).  Kangxi Medical manufactures and sells branded external use Chinese medicine and other natural products under the registered trademark “Kangxi.”  Our Kangxi Medical division has four production lines: spray, ointment and cream, powder, and patch.   In July 2006 Kangxi Medical was merged into Harbin Bio-Engineering with Harbin Bio-Engineering as the surviving subsidiary of TDR.   

Harbin Tian Qing Biotech Application Company; Research and Development

We have also recently organized Harbin Tian Qing Biotech Application Company as a wholly-owned PRC subsidiary of TDR, to conduct research and development in the areas of tissue and stem cell banks, which is described in more detail below. (See “Research and Development” below.)  

Heilongjiang Pharmaceuticals; External Use Pharmaceuticals

On April 3, 2008, our TDR subsidiary completed the acquisition, pursuant to an Equity Transfer Agreement entered into on February 22, 2008 between TDR and Heilongjiang Tianlong Pharmaceutical, Inc., a corporation organized under the laws of the PRC (referred to herein as “Heilongjiang”), which is in the business of manufacturing external-use pharmaceuticals. TDR previously, in 2006, acquired the Beijing office of this company. Additional information about the terms of this acquisition and the business of Heilongjiang Pharmaceuticals is contained in “Recent Developments” below. Heilongjiang’s assets include, among other things, GMP-certified manufacturing facilities, state-of-the-art manufacturing equipment, an research and development center, approximately $500,000 in inventory, sixty-nine (69) SFDA-approved medicines, and an additional thirty-eight (38) new medicines, which have been submitted for approval to the State Food and Drug Administration of China (SFDA). In addition, approximately 130 employees of HTP have agreed to continue in their current capacities as employees of HTP. The acquisition was approved by China’s Department of Industry and Commerce as of April 3, 2008.

Product Line

We manufacture over thirty-eight (38) branded products, which management believes enables us to maintain better control over product quality and availability while also reducing production costs.   We also sell a total of eight (8) products manufactured by other firms (See “Other Products,” below).  Our manufacturing operations are conducted in our indirect subsidiaries’ facilities located in Harbin City, China.  Additionally, we maintain a working relationship with a number of outside manufacturers, including softgel manufacturers and packagers, and utilize these outside sources from time to time.  
 
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We sell our products under three basic categories:  cosmetics  (4 items); medical devices (4 items); and external use medicinal or pharmaceutical external use products (over 22 items).  We sell these products in four main different forms, including, without limitation, sprays, ointments and creams, powders, and patches.  A description of our main product lines follows.

Sumei Slim Patch

The Sumei Slim Patch is marketed and sold in the PRC as a more natural way to lose weight.  The Sumei Slim Patch uses Saponin, believed to regulate and restrain the excessive secretion of certain hormones, while promoting others. The Sumei Slim Patch is also believed to foster weight loss and prevent weight gain.

Pain Killer Patch

A pain killer patch applied to the neck, shoulder and waist, this product is a treatment to fend off fever, promote well-being and to relieve diarrhea.  The patch is used for a number of ailments, including fever, headache, dysentery of a heat type, diarrhea and stiffness and pain in the neck caused by hypertension.

Anti-Hypertension Patch

The anti-hypertension patch is based on five thousand years of Chinese herbal vein therapy that has been adapted to a modern trans-dermal therapeutic system (TTS).  The product utilizes a Body-Yong-Guan point technique, which is believed to maximize the effectiveness of the medicinal ingredients.  The product is believed to stimulate blood capillaries and is believed to be effective in improving circulation and in reducing blood pressure.

Dysmenorrheal Patch

This is a soft patch, applied externally, for pain relief from dysmenorrheal (menstrual cramps) that combines traditional Chinese point therapy and modern trans-dermal technology.   This product contains a pure herb formula selected from rare Chinese herbs or plants which is refined to extract the effective ingredients.  This product is believed to be effective in regulating microcirculation, in balancing the functions of the human body and in enhancing the immunity response of women.  It is believed to be effective in treating the dysmenorrheal (cramping) in a woman’s critical days, and in regulating pain and catamenia (menstruation period).  

Yin Ke Psoriasis Spray

Psoriasis is a skin disease that is difficult to treat.  Our research scientists have focused their efforts in finding treatments for this disease.  Yin Ke Psoriasis Spray is a spray that contains Chinese herbal ingredients that are believed to be effective in killing pathogenic ringworms inside or under the skin, causing scale-like skin to fall off, and allowing healthy skin to grow.

Wart Removing Spray

This product has been developed to eliminate the viruses in a tumors or warts.  The product is effective in removing warts, through a strong permeation and sterilization process.  The product is a highly concentrated washing liquid that is applied topically to the affected area.  
 
Chilblain Ointment

This product contains Rhizoma Paridis, Rhizoina Bletilae and Camphor, and is refined from Chinese herbal materials.   It is believed to be effective in improving blood circulation, and in eliminating various symptoms of Chilblain (a cold injury that appears as an inflamed swelling on the extremities), including itching and swelling.   

Hemorrhoids Ointment

This product contains Acetate, Radix notoginseng, and Rhizoma coptidis.  The product is made in a soft ointment that is effective in sterilizing and relieving hemorrhoid symptoms, including itching, distending pain, burning, and bleeding.  
 
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Tinea Pedis Spray, Ointment and Powder

This product contains Cortex Pseudolaricis and Cortex Phellodendri, and is a treatment for killing various pathogens on the skin surface and subcutaneously, such as mycete (a fungus), trichopytic, staphylococcal bacteria aureus, bacillus coli, and candida albicans (thrush).  

Dermatitis Spray

This product is effective in sterilization and in relieving itching in various kinds of skin pruritis (intense itching condition) caused by eczema, urticaria (hives), seborrheic dermatitis (flaking of skin, dandruff), herpes zoster (shingles), neurodermitis and allergic dermatitis.   

Dandruff Treatment Herbal Shampoo

This product has been specifically designed to treat dandruff, and is not intended for use as an ordinary shampoo.   The product is believed to be effective in killing fungi and providing nutrition to pallium cells.

Runze Eye Drop

This product is refined from active ingredients extracted from natural herbs or plants, and functions as a protection from infection, tiredness of optic nerves and myopia.

Testing Kits Approved and Brought to Market in 2007

Cardiac Arrest Early Examination Kit

This product is used for early stage diagnosis of myocardial infarction (heart attacks). We completed SFDA clinical testing of the Cardiac Arrest Early Examination Kit and began sales of this product in 2007. This kit is patented in PRC.
 
Kidney Disease Testing Kit
 
The Urinate Micro Albumin Examination Testing Kit is used in connection with early stage diagnosis for primary kidney disease, hypertension and diabetes. We completed SFDA clinical testing for the Urinate Micro Albumin Examination Testing Kit and commenced sales of this product in 2007. This kit is patented in PRC.

Other Products

TDR offers a number of additional products made from Chinese herbs and plants, including a leukoderma ointment, rheumatism spray, Coryza powder, Hircus removing spray, gonorrheal cleaning spray, a snoring retardant, deodorants, diet tea, cough arresting patch, pharyngitis spray, and others.   

Historically we have sold only products that we manufactured. However, during the 2007 fiscal year, we began an initiative to sell medicinal products manufactured by other companies under exclusive sales and marketing arrangements.   Set forth in the table below is information concerning these products and the intended treatment applications.  

Product Name
 
Treatment Applications
 
Main Component
Ofloxacin Eye Drops
 
Conjunctivitis, keratitis
 
Ofloxacin
Ribavirin Nasal Drops
 
Influenza
 
Ribavirin
Econazole Nitrate Suppositories
 
Colpitis (inflammation of the vagina)
 
Econazole Nitrate
Qianliming Nasal Drops
 
Coryza (head cold)
 
Ethyl ester hydroxybenzene, etc.
Terbinafine Hydrochloride Liquor
 
Tinea (scalp ringworm)
 
Terbinafine Hydrochloride
Compound Camphor Cream
 
Eczema, dermatitis, etc.
 
Camphor, menthol, methyl salicylate
Terbinafine Hydrochloride Cream
 
Tinea (scalp ringworm)
 
Terbinafine Hydrochloride
Sulfasalazine Suppositories
 
Colonitis
 
Sulfasalazine

Total sales in 2007 from products manufactured by other companies under exclusive sales arrangements totaled approximately $12,998,000 or approximately 26% of total sales in the year ended December 31, 2007, as compared to $6,383,000, for the year ended December 31, 2006.   We market and sell these products through our existing distribution channels to our customers throughout the world and primarily in China.   We intend to expand our product line under sales and manufacturing contracts with third-party manufacturers with a goal of increasing sales revenue from current and new pharmaceutical and medicinal products manufactured by other companies.  
 
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Revenues by General Product Lines
 
Management believes that the most accurate benchmark of revenue breakdown is based on the method of application as different applications have different sales channels. Below is a breakdown of revenues for 2007 based on application and application usage.
 
Revenues based on Application Category
 
Our revenues during 2007 were $49,318,308. The following table sets forth our principal product categories based on application type and the approximate amount and percentage of revenue from each of such product categories, during the fiscal year ended December 31, 2007:

 
 
Revenue in 2007
 
 
Product Category
 
Approx.
Amount (U.S.$)
 
Approx.
% of Revenue
 
Sprays
 
$
8,742,088
   
18
%
Patches
   
1,402,736
   
3
%
Ointments
   
3,269,732
   
7
%
Liquids, Creams and Powders
   
1,704,979
   
3
%
Miscellaneous Health and Beauty and Products Manufactured by others (43 items)
   
34,198,773
   
69
%
Total Gross Sales From Above Categories
 
$
49,318,308
   
100
%
 
Research and Development

We currently conduct all of our research and development (“R&D”) activities, either internally or through collaborative arrangements with universities and research institutions in the PRC.   We have our own research, development and laboratory facilities located at TRD’s principal headquarters in the city of Harbin, Heilongjiang Province.   We have also recently organized Harbin Tian Qing Biotech Application Company (“Harbin Biotech”) as a wholly-owned PRC subsidiary of TDR, to conduct research and development in the areas of tissue and stem cell banks, which is described in more detail below.   In all, our internal R&D team currently consists of approximately 35 people, of which 25 are full time researchers and 10 are part time technical experts. Many of our team members are professors affiliated with universities in the PRC.

Additionally, we have established several long-term partnerships with well-known universities and enterprises in the PRC.  We have built a gene medicine laboratory through a collaborative effort with Harbin Medical University; established a cell laboratory with North East Agricultural University; and founded a monoclonal antibody laboratory with Jilin University.   Under our partnership arrangements with other universities and research institutions, we will generally hold the intellectual property rights to any developed technology.   As a result of one of these collaborations with Harbin Medical University, a product known as “Endothelin-1” is currently under development as a cancer suppressing product. Additional information relating to this product and other products being developed is set forth under “Products Under Development” below and under the general product descriptions throughout this prospectus.

During the year ended December 31, 2007 we invested $3,158,351 in our own internal R&D with approximately $2,707,679 (18,970,000 RMB) (unaudited) invested by our R&D partners. Our R&D investments in 2006 were $2,026,788. Additional information about our R&D investments is included in the financial statements to this prospectus (and notes thereto) and our “Management Discussion and Analysis on Financial Condition and Results of Operations” section below.

Products Under Development

At present, our ongoing research is divided into five general areas:  (1) the development of an enzyme linked immune technique to prepare extraneous diagnostic kits (see table below); (2) the development of an enzyme linked gold colloid technique to prepare extraneous rapid diagnostic test strip; (3) the development of a gene recombination technique to prepare gene drug; (4) the development of a biology protein chip for various tumor diagnostic applications; and (5) the development of a cord blood stem cell bank described below.
 
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Biological Products - Examination and Diagnosis Kits

We currently have various biological products under development at various stages of clinical testing and development.  The development of some of these products are expected to be completed as early as 2008 or beyond for other products.   A summary of each of these products is set forth in the table below.  
Testing Kits Name
 
Clinical Experiment and Status
 
 
 
Application Area
 
Patent or
Intellectual Property (IP)
AIDS Early Examination Kit
 
Completed clinical testing; application for manufacturing certificate submitted.
 
Early stage diagnosis for AIDS
 
Method of Anti-body preparation is our IP.
             
Carcinoma Cervix Early Examination Kit
 
Research completed and application for manufacturing certificate submitted.
 
Early stage diagnosis for Carcinoma Cervix
 
Anti-body preparation is our IP.
             
Breast Cancer Early Examination Kit
 
Research on product formula completed; and application for production permit submitted.
 
Early stage diagnosis for Breast Cancer.
 
Anti-body preparation is our IP.
             
Liver Cancer Early Examination Kit
 
Research on product formula completed; clinical experiment in process.
 
Early stage diagnosis for Liver Cancer.
 
Anti-body preparation is our IP.
             
Rectal Cancer Early Examination Kit
 
Research on product formula completed; clinical experiment in process.
 
Early stage diagnosis for Rectal Cancer.
 
Anti-body preparation is our IP.
             
Stomach Cancer Early Examination Kit
 
Product research completed; clinical experiment in process.
 
Early stage diagnosis for Stomach Cancer.
 
Anti-body preparation is our IP.
             
Multi-tumor Marker Protein Chip Assay Kit
 
Product research in process.
 
Early stage diagnosis for multiple cancers.
 
Anti-body preparation is our IP.
             
New Endostatin
 
Toxicology test, teratogenicity test and quality standard completed; product research in process.
 
Early stage diagnosis for cancer.
 
Anti-body preparation is our IP.

New Products

We are currently conducting toxicology experiments, quality standard measurement and other experimentation for our products under development.  It is estimated that the experimental time takes about another seven to eight months for each product. We also hope to commence with clinical testing of 8 testing kit products in 2008 for: Uterine cancer, cervical cancer, ovulatory cancer, liver cancer, breast cancer and neisseria gonorrhea.  We cannot predict whether, and when, these efforts will be successful, or the likelihood and/or timing of receiving SFDA approval of each product.

Research and Development

Research and Development for Endothelin-1

One of our various products under development is Endothelin-1. As of the date of this prospectus, we have already completed oxicology and teratogenicity testing, and have established quality standards, and further developments are underway to improve the product quality of Endothelin-1.   In collaboration with Harbin Medical University, we have completed a laboratory experimental study pertaining to Endothelin-1, which is required prior to clinical trials, and is currently applying for approval to enter clinical experiments. At such time as development and clinical testing is successfully completed, we will commence efforts to market Endothelin-1 in the PRC and where legal, as a new anti-cancer medicine.  There can be no assurance, of course, that these development efforts, or that any subsequent efforts to obtain SFDA approval (or other foreign drug regulatory authority approval where we may wish to market this drug) of the product, will be successful. We hope to develop Endothelin-1 as a cancer treatment drug that works by “starving” cancer cells by restricting the generation of blood vessels around cancer lesions, thereby inhibiting, to a degree, the source of nutrients upon which the cancer cells survive. Endothelin-1 has been recognized by the PRC medical industry as a “Top Category in New Medicine.” In order to qualify as the “Top Category in New Medicine,” a company must have intellectual property rights, high technology involvement, strong innovation, and the medicine must be the first of its kind to be introduced to the PRC.   TDR has ownership of the intellectual property rights pertaining to this technology, and has obtained an invention patent in China for Endothelin-1.   We expect that research and development and testing will be completed for manufacturing in 2009. To date we have expensed over approximately $2,278,047 (15,690,000 RMB) (unaudited) on research and development for Endothelin-1.
 
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Research and Development for Cord Blood Stem Cell Bank
 
In 2006, we began implementing a plan to establish a cord blood stem cell bank in the PRC, for the treatment of various diseases such as leukemia, lymphoma and rebirth anemia. We are now in the process of perfecting our cultivation methods and freezing/storage of stem cells. It is expected that these efforts will continue over the next two years or more in particular in the research and development of technology, applications and methodology for the establishment of a cord blood stem cell bank.  We have recently organized Harbin Tian Qing Biotech Application Company (referred to herein as “Harbin Biotech”) as a wholly-owned subsidiary, to conduct research and development in the areas of tissue and stem cell banks.   This project will involve substantial expense and involve numerous risks.   We entered into a development agreement with the Heilongjiang Provincial Red Cross out-patient department for purposes of defraying the costs of developing and marketing this product and are seeking additional R&D partners with laboratories having substantial experience in this area for this purpose as well.

Exclusive Regional License for Stem Cell Research

Research in biotechnology areas such as tissue and stem cell banks has historically been controlled tightly by the government of the PRC.   Recently, however, the PRC government has altered its policies to allow one company per each geographic area in China to become actively engaged in research in these areas, with the result that many companies have applied to become engaged in this area of research and development, including the Company.  

In August, 2006, we applied with the Ministry of Health of the PRC to become engaged in the research and development of stem cell and tissue banks and related biotechnology areas.   Following an extensive review by the applicable local office of the Health Department of Heilongjiang Province, our application was approved on October 16, 2006, granting us, through our subsidiary, the exclusive right and license to become engaged in tissue and stem cell bank activities in the Heilongjiang Province of the PRC, through December 2010 and currently intend to renew this license from time to time as necessary.  The Company organized Harbin Biotech to conduct these business operations, as required by Heilongjiang Province.  Cord blood stem cells have been shown to be effective in treating a number of diseases, including but not limited to:   (a) various forms of blood diseases, including Mediterranean anemia, Dresbach’s anemia, hypoplastic anemia, inborn cell deficiency, Evan’s syndrome, Fanconi’s anemia, Kostmann’s syndrome, and Blackfan-Diamond’s anemia; (b) various malignant diseases, including encephaloma, lymphoma, acute and chronic leukemia, Ewing myoma, Neuoblastoma, germ cell tumor, and multiple myeloma; (c) metabolism defects, including congenital dyskeratosis, Gunter’s disease, and Lesch-Nyhan’s disease; (d) immunodeficiency disease, including chronic granuloma disease and Wiskott-Aldrich syndrome; and (e) various auto-immune diseases.   

Our Stem Cell Research

There are numerous advantages of cord blood stem cell banks over traditional marrow transplants, including:  a high success rate; low rejection rate; rich source of cord blood; absence of suffering of recipient; simple inspection and quick application; and low matching requirements.   While we are not aware of a method to calculate the size of the stem cell market, management believes that the market for this business in PRC and elsewhere is potentially very large.  The entry into this business will require strict examination and approval by PRC and local governmental agencies and will require close collaboration with medical institutions and academies.      

Blood from umbilical cords—a byproduct of normal childbirth—is a good source of potentially life-saving stem cells, called Hematopoietic progenitor cells (HPCs), the type of stem cells also found in bone marrow and mobilized peripheral blood that give rise to various kinds of blood cells.   Transplants of these stem cells have been effective in treating diseases of the blood and immune system, such as anemia and leukemia. Consequently, in many parts of the world, cord blood, once seen as a waste to be discarded after a birth, is now viewed as a valuable resource.   

Over the past decade, several public and private cord blood banks have been established in other parts of the world to provide for the collection and preservation of these cells.   The PRC is now making these activities available to a limited number of private enterprises in different parts of the PRC, including the Heilongjiang Province where the Company conducts its principal operations.   As indicated, our Harbin Biotech subsidiary will have the exclusive right and license to establish a research and development business in this area in northeast China through 2010. 

Typically, public cord blood banks collect and store umbilical cord blood donated by women at the birth of a child.   This blood is preserved and stored and made available for a significant fee to anyone who needs it in the future.   The children of the donor may, in turn, be able to use the stored stem cells to fight various diseases, immune deficiencies and genetic disorders.   Storing the stem cells will come at a cost to the donor, consisting of a sizable initial fee and an annual maintenance fee for each year of storage.  
 
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Through Harbin Biotech, we are in the process of implementing a plan to establish a cord stem cell and tissue bank at our newly established facility outside Harbin, Heilongjiang Province, PRC, which is expected to be completed in 2008 or 2009.  Management estimates that the total expected project costs to complete the project will be US $30 million.

This project is a substantial commitment by the Company, and consequently involves a number of significant risks, including, without limitation:

·
our need to raise substantial additional capital to fund our stem cell R&D project over the next two or more years, through borrowings, the sale of equity or from income from operations, which, if not obtained on a timely basis, the could severely compromise this project and our rights,
   
·
our continued compliance with laws and requirements of the PRC and reliance on a license from the PRC government to engage in these research and business operations in northeast China on an exclusive basis,
   
·
the developing nature of stem cell banking and research, and numerous technical and development challenges, including issues pertaining to the long-term viability of cryogenically frozen cord blood, and  
 
·
our reliance on the efforts of management, in particular Liu Yan-Qing, our President to continue to manage our stem sell research.   

There can be no assurance we will be successful in obtaining capital when needed, or on favorable terms or that the PRC government will not restrict or cancel our rights, or allow other competitors to become engaged in this business in northeast China, which would make it more difficult for us to compete.  

While we do not expect that our research and development in this area will have a negative impact on our current core business - the manufacture, marketing and sale of nutritional and medicinal products - the development of this business will require substantial managerial, technical and financial resources.   

During the 2007 fiscal year, the Company had capital expenditures of over $10,671,398 (74,763,814RMB) on equipment and construction; $3,427,979 (24,016,420 RMB) on R&D and $256,922 (1,800,000RMB) on initiating and continuing the stem cell bank program as well as additional costs in previous periods on equipment, construction and R&D as described in this prospectus.
 
Sales Approach
 
We have established a domestic marketing network for our products covering most of the PRC mainland, and have employed sales agents in these areas.  Our target customers are chain drug stores and hospitals in all cities.  We use distributors to sell products in those countries and remote regions where we do not have sales agents.  We have established a marketing network through independent agents to develop an international market.  At present, while our primary initial growth focus remains mainland PRC, we have also established over 20 international agents to sell our products, and are expanding our overseas sales efforts.
 
Materials and Suppliers
 
We employ a purchasing staff with extensive knowledge of our products who work with marketing, product development, and formulations and quality control personnel to source raw materials for products and other items.   Raw materials are sourced principally in the PRC, and are generally available from a variety of suppliers.  No one supplier accounts for more than 20% of our total raw material purchases.  We seek to mitigate the risk of a shortage of raw materials, through identification of alternative suppliers for the same or similar raw materials, where available. We manufacture bulk branded products to allow more extensive vertical integration and to improve the quality and consistency of raw materials.
 
Customers and Distribution
 
Currently, our products are sold primarily in the PRC and, to a lesser extent, in Hong Kong and in eleven other countries as listed above.  Approximately 75% of our revenues in 2007 were from the sale of products in China and Hong Kong with Malaysia marking our largest country of export.   

Over the past several years, we have continuously expanded our distribution channels for our products.   As a result, we have established representative sales offices in 22 provinces and 125 municipalities, and deployed sales managers and representatives in each of these markets.  

Our products are sold directly to retail stores, including pharmacies and drug store chains, and through independent distributors.   We currently have 943 customers, not including branches of retail and drug supply chains. Only two customers accounted for more than 5% of our total revenues in 2007.  
 
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As a means of accelerating our distribution into other countries, we expect that we will enter into strategic marketing arrangements with firms that have distribution channels, brand name recognition or other unique marketing strengths.  Under a typical arrangement we expect to will grant limited exclusivity to a sales agent or distributor to certain products in a specified territory(ies), subject to the agent meeting specified minimum monthly or annual sales numbers.  Consistent with this approach, in March, 2007, we entered into an exclusive strategic agreement with Takasima Industries (“Takasima”), under the terms of which Takasima has been engaged as the exclusive sales agent of our patch products in Malaysia.  Takasima will offer our Slim Patch products in Malaysia, under Takasima’s name brand.  (See “Item 6.  Management’s Discussion and Analysis”).  

We also export a number of its products to various countries, including Malaysia, United Arab Emirates, United Kingdom, Hong Kong, the United States, and others, and utilize agents and independent distributors for these marketing and sales efforts.  

We will continue efforts to expand our markets into other provinces and larger cities in the PRC, and to other markets worldwide.  
 
Competition

Competition in the TCM, pharmaceutical, and over-the-counter nutraceutical business is intense in China and throughout the world.  We compete with various firms, many of which produce and market products similar to our products, and many of which have greater resources than us in terms of manufacturing and marketing capabilities, management expertise and breadth, and financial wherewithal.  Some of these competitors are far larger, have more resources then us and have stronger sales and distribution networks.

Our direct competitors are other domestic firms engaged in developing, manufacturing and marketing TCM and nutraceutical products. There are many of these companies in the PRC, in Heilongjiang Province and even in the city of Harbin.     

We expect that the competition for medicinal products in the PRC and other world markets will become more intense over the next few years both from existing competitors and new market entrants.  We will also face competition from foreign companies who may have established products, a strong proprietary pipeline and strong financial resources.   Our management believes that we have certain competitive advantages in introducing new products to market due to key focus areas for development, our existing distribution channels, research and development capabilities and our relationship with certain universities and other research institutions.   However, there can be no assurance that we will be able to compete and continue to grow in this highly competitive environment. Additional information relating to Competition in the PRC can be found in the “Risk Factors” section above.

Properties

Our facilities are located on approximately 92,000 square meters of land, including two buildings in the city of Harbin, Heilongjiang Province. We also have a sales and marketing facility in Beijing, PRC.

Under Chinese law, the government owns all of the land in the PRC and companies and individuals are authorized to use the land only through land use rights granted by the PRC government.   The PRC has granted TDR a land use grant covering the land and facilities in which its headquarters are located in downtown Harbin City, which expires in 2046.  The PRC has granted land use rights on TDR’s two production and warehouse facilities, expiring in 2048 and 2053, respectively.  TDR’s two buildings contain GMP production certified facilities, and are used for manufacturing office, warehousing and staff operations.  

Description of Production and Other Facilities

We have two separate facilities, headquartered in the city of Harbin in the Heilongjiang Province of China.  The older facility includes 3,000 square meters of production space, and 1,000 square meters of warehouse.  The facility also includes an extraction workshop (approximately 1,200 square meters) and filling workshop (approximately 500 square meters) for traditional Chinese medicines; a patches production line (approximately 500 square meters), packing workshop (approximately 500 square meters), testing workshop (approximately 50 square meters), examination laboratory (approximately 100 square meters), sample laboratory (approximately 50 square meters), refining room (approximately 100 square meters), and a work-in-process warehouse (approximately 300 square meters); finished product warehouse (approximately 200 square meters), materials warehouse (approximately 100 square meters) and a packing warehouse (approximately 400 square meters).

The newer facility consists of a four floor office building (1,500 square meters for office purpose, 1,200 square meters for R&D center, 800 square meters for central examination lab, dormitory and eatery 1,000 square meters), total 4,500 square meters construction area, and a factory of 3,500 square meters.   The facilities also include: an enzyme immunity reagent kit production workshop (1,500 square meters) and a colloid gold production workshop (600 square meters); a packing workshop (800 square meters); and an examination lab (500 square meters). The newer facility also includes a research center covering approximately 1,200 square meters, for research pertaining to the development of various products, including traditional Chinese medicinals (TCM), biological medicine, gene medicine, immune body research, and vitro diagnosis reagent.  These facilities also include an electricity room, heating and boiler room and garage.  Our enzyme immunity examination reagent kit production workshop includes antigen and immune body areas, disinfection room, aseptic clothes room, cushion room, weighing room, separation room, cleaning equipment room, a Wan Ji flow cushion room, and antigen and immune body sign room.  The enzyme sign processing area has cushion room, cloth cleaning room, cleaning equipment room, packing material temporary storage room, raw material temporary storage room, equipment storage room, weighing room, seal protection room, seal foster room, drying room, packing room, and middle cooler room.  The work fluid separation loading room includes a disinfection clean room, storage room, weighting room, loading room, and immune body purification room.  The colloid gold production workshop has a darkroom, sample room, seal room, cementation room, cutting room, and a packing room.  The packing workshop includes a central equipment room, a cooler room, material relay room, label and temporary storage room, a packing material temporary storage room, two examination cooler rooms, and two finished product cooler rooms.
 
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We also have a sales office in Beijing, which TDR acquired in December of 2006, when it completed the acquisition of the products, dealership and marketing network of Heilongjiang. In addition to the above, our properties include GMP-certified manufacturing facilities of Heilongjiang and manufacturing equipment which was acquired on April 3, 2008. (See “Corporate History” above and “Recent Developments” and “Management’s Discussion and Analysis or Plan of Operation” below).

Our production facilities are operated in accordance with “good manufacturing practices” (“GMP”).    

Government Regulation

Regulatory Environment

Our  principal sales market is in the PRC.   We are subject to the Pharmaceutical Administrative Law of the PRC, which governs the licensing, manufacturing, marketing and distribution of pharmaceutical products in the PRC, and sets penalties for violations.   Our business is subject to various regulations and permit systems of the government of the PRC. Additionally, we are subject to government licensing rights and regulations, which relating to our stem cell R&D license. Permits we attain for TCM products are granted on a non-exclusive basis and one limited for four to five years.

The governmental approval process in the PRC for a newly developed health product can be lengthy and difficult.   A product sample is first sent to a clinical testing agent designated by the Ministry of Health, which conducts extensive clinical testing and examinations of the product to verify if it has the specified functions as stated by the company producing the product.   A report will then be prepared and issued by the clinical testing agent confirming or negating such functions.   It generally takes six months to one year for a report to be issued by the testing agent, after submittal to the agent.   The report must then be submitted to a provincial Health Management Commission for approval.   Following this submittal, a letter of approval issued by such commission will be submitted to the Ministry of Health for the issuance of a certificate that authorizes sale and marketing of the product in the PRC.  

This entire process will generally take between eighteen months and two years.   The approval process will depend to a certain extent on whether a specified product is a plant based pharmaceutical (“PBP”) or a plant based nutraceutical (“PBN”).   PBPs are products composed of herbs, roots and plants that do not use synthetic chemicals, with certain medicinal functions for treatment of one or more illnesses.  PBPs are generally prescription-based but in some cases may be sold over-the-counter.   PBNs, also frequently known as “dietary supplements” or “nutritional supplements,” are also composed of herbs, roots and plants, but are essentially prophylactic or preventive in nature.  All PBNs are available over-the-counter without a prescription.   In the PRC, PBPs require the approval of the SFDA, and PBNs only require the approval of state and local governments prior to manufacturing and sale.   Obtaining the approval from the SFDA is generally more complex and lengthy.  

 Because we and our subsidiaries are wholly-owned enterprises, we are subject to the law of foreign investment enterprises in the PRC, and the foreign company provisions of the Company Law of China, which governs the conduct of our wholly-owned subsidiaries and their officers and directors, and also limits our ability to pay dividends.   

Compliance with Environmental Law

We comply with the Environmental Protection Law of the PRC, as well as applicable local regulations.   In addition to compliance with the PRC law and local regulations, we consistently undertake active efforts to ensure the environmental sustainability of our operations.   Because the manufacturing of herb and plant-based products does not generally cause significant damage or pollution to the environment, the cost of complying with applicable environmental laws is not material.   In the event we fail to comply with applicable laws, we may be subject to penalties.    
  
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Intellectual Property

We regard our service marks, trademarks, trade secrets, patents and similar intellectual property (“IP”) as critical to our business.  We have relied, and will continue to rely, on patent, trademark and trade secret law, as well as confidentiality and license agreements with certain of our employees, consultants, customers and others, to protect our proprietary rights.  

Under the PRC State Protection law, certain herbal medicine products which have received approval from the SFDA, have automatic protected IP rights for a seven-year period from the date of grant of such approval.  An application can be submitted to extend such protection for up to three consecutive seven-year periods.   Once this protection period has expired, an applicant may apply for patent protection in the PRC which lasts for up to 20 years for traditional medicines depending on the type of patent, and is renewable for indefinite number of times. Patents for arts and crafts and packaging have 10 year patent protection periods which are also renewable.   To a large extent, we rely on such State Protection law to protect our IP rights with respect to our products. In addition, as of the date of this filing, we own a total of 6 patents and one patent application (Endothelin-1) in the PRC, pertaining to our TCMs and biotech diagnostic kits and drugs, as follows:

 
·
Package foil bag design patent of Sumei slim patch, registered December 4, 2001;
     
 
·
Package box design patent for all TCM products, registered December 4, 2001;
     
 
·
Arts and crafts patent of Human Urinary Albumin Elisa Kit, registered August 24, 2004;
     
 
·
Arts and crafts patent of Sumei slim patch, registered in 2001;
     
 
·
Arts and crafts design patent of myocardial infarction testing kit, registered March 16, 2004;
     
 
·
Arts and crafts patent of Suning cough removing patch, initially registered December 4, 2001; and
     
 
·
Endothelin-1 patent relating to anti-tumor technology (application for public instruction made), registered October 4, 2006;

We have received awards and grants from the government of the PRC for R&D in 2007 for the below listed products, resulting in a total amount of $2,141,022 (15,000,000 RMB) of which $42,492 (300,000 RMB) has been paid with the remaining amount anticipated to be available to us in 2008:

 
·
High Technology products certificates by Heilongjiang High Technology Products Committee covering the following products:
     
 
·
The Coryza Spray;
     
 
·
Dermatitis Spray;
     
 
·
Pharyngitis Spray;
     
 
·
Tinea Pedis spray;
     
 
·
Gonorrhea Cleaning Spray;
     
 
·
Wart-removing liquid;
     
 
·
Sumei Slim patch;
     
 
·
Suning Cough removing patch; and
     
 
·
Psoriasis Spray.
     
 
·
National Class Torch Project (pertaining to the Sumei slim patch);
     
 
·
Excellence Products Award for Human Urinary Albumin Elisa Kit by The 6th New & High Technology Fruits Fair Shen Zhen and National Commercial Department;
     
 
·
100 important pre-phase projects in Heilongjiang Province covering various medical diagnostics kits;
     
 
·
Material Medical Technology Research and Development Company (by Heilongjiang provincial Science and Technology Bureau); and
     
 
·
High Technology Industrialized Base of Medical Area, by Heilongjiang Provincial Development and Reform Committee (March of 2006).
 
Trademarks
 
We have registered “Kang Xi” as our trademark, which is used for all of our TCM products.
29

 
Employees
 
The number of our employees has increased over the past two years, due to growth, increased research and development and expanded marketing and distribution of products   Currently we have a total of approximately 1,443 full time employees and manufacturers’ representatives, generally falling into the following categories:  

By subsidiary company:  

Company
 
Number of 
Employees
 
TDR  (includes Harbin Biotech)
   
1,269*
 
Harbin Bio-Engineering
   
174
 
TOTAL: 
   
1,443
 
 
By nature of job (TDR and Harbin Bio-Engineering combined):       

Type of Job    
Number of Employees
 
Executives and Managers
   
26
 
Production and clerical
   
170
 
Sales and Marketing
   
1,222
 
Research and Development, Technology
   
25
 
TOTAL:
   
1,443
 

* Includes manufacturers’ representatives.
 
** Does not include 10 part time technical researchers.

In addition to the above, approximately 130 employees of Heilongjiang have agreed to continue in their current capacities as employees of Heilongjiang as a result of our acquisition of them in April 2008.

We do not have employment agreements in place with our executive management.  None of the employees are covered by a collective bargaining agreement, however, we believe our relationship with employees is good.   

Legal Proceedings.

We are not a party to any material pending legal proceedings, and to the best of our knowledge, no such proceedings by or against the Company have been threatened.

Recent Developments

On January 31, 2008 China Sky One entered into a Securities Purchase Agreement with certain accredited investors, for the purchase and sale of 2,500,000 units of securities at $10.00 per unit, pursuant to which we sold an aggregate of (i) 2,500,000 shares of common stock, and (ii) Class A Warrants to purchase 750,000 additional shares of common stock, at an exercise price of $12.50 per share, for an aggregate purchase price prior to expenses and fees of $25,000,000. Holders of the 2,500,000 shares of common stock sold in this offering have certain put rights and rights to receive additional shares from certain key shareholders in the event that certain thresholds are not met. Additional information relating to the securities sold in this offering and to the put or make whole rights of the investors may be found in the Risk Factors of this prospectus, in the section under the caption “Item 5. Market for Common Equity and Related Stockholder Matters” and in the section titled “Item 6. Management’s Discussion and Analysis or Plan of Operation” and other sections below and are incorporated by reference.

As of February 22, 2008, the board of directors of China Sky One authorized an increase in the number of directors on the Board from three (3) to seven (7), and appointed Song Chun Fan, Jiang Qi Feng, Zhao Jie and Qian Xu Feng to fill the vacancies created as a result of such increase, to serve until such time as their successors shall be duly elected, unless they resign, are removed from office, or are otherwise disqualified from serving as directors of the Corporation. The biographies of Song Chun Fan, Jiang Qi Feng, Zhao Jie and Qian Xu Feng as well as additional information relating to these committees is also provided below in the section captioned “Item 9. Directors, Executive Officers and Corporate Governance”.

On April 3, 2008, TDR completed an acquisition pursuant to an Equity Transfer Agreement dated February 22, 2008, between TDR and Heilongjiang Tianlong Pharmaceutical, Inc., a corporation with a multitude of SFDA approved medicines and new medicine applications, organized under the laws of the PRC (“Heilongjiang”), which is in the business of manufacturing external-use pharmaceuticals. Our TDR subsidiary previously acquired the Beijing sales office of Heilongjiang in mid 2006. Pursuant to the Equity Transfer Agreement, TDR acquired 100% of the issued and outstanding capital stock of Heilongjiang from Heilongjiang’s sole stockholder Wu Jiechen, a resident of China, in consideration for an aggregate purchase price of approximately $8,300,000, consisting of (i) approximately $8,000,000 in cash, and (ii) approximately $300,000 of shares of common stock (24,809 shares, $.001 par value per share) of the Registrant. The seller had no material relationship with the Registrant or any of its affiliates, or any director or officer of the registrant, or any associate of any such director or officer. Additional information relating to this entity can be found elsewhere in this “Business” section and in “Recent Developments” at the end of this section below.
 
As a result of its purchase of the existing business of Heilongjiang, TDR acquired all of Heilongjiang’s assets, including, without limitation, land use rights, GMP-certified manufacturing facilities, state-of-the-art manufacturing equipment, an research and development center, approximately $500,000 in inventory, sixty-nine (69) SFDA-approved medicines, and an additional thirty-eight (38) new medicines, which have been submitted for approval to the State Food and Drug Administration of China (SFDA). In addition, approximately 130 employees of Heilongjiang have agreed to continue in their current capacities as employees of Heilongjiang. The acquisition was approved by China’s Department of Industry and Commerce as of April 3, 2008. The foregoing is a summary and additional information relating to this acquisition can be found in our Current Report on Form 8-K/A dated February 22, 2008, and Current Report dated April 3, 2008 including the
 
30

 
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
 
FORWARD LOOKING STATEMENTS
 
The following discussion should be read in conjunction with the information contained in the consolidated financial statements of the Company and the notes thereto appearing elsewhere herein and in the risk factors and “Forward Looking Statements” summary set forth in the forepart of this prospectus as well as the “Risk Factors” section above and are afforded the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Readers should carefully review the risk factors disclosed in this prospectus and other documents filed by us with the SEC.

DISCUSSION

We acquired our current PRC based business on May 30, 2006 by acquiring all of the shares of common stock of American California Pharmaceutical Group, Inc., a California corporation formed on December 16, 2003 (“ACPG”), from its shareholders in exchange for 10,193,377 shares of our common stock (approximately 93% of our common stock at the time), resulting in a change of control of the Company, then known as Comet Technologies, Inc. The transaction is treated as a reverse merger for accounting purposes. At the time of this acquisition, ACPG had already owned TDR and its subsidiaries, which it acquired in 2005. ACPG does not have its own operations or revenues other then its ownership of TDR.

We primarily generate revenues and income and generate cash from sales by our PRC based subsidiaries, of products in the areas of external-Chinese medicine and over-the counter non-prescription health care products in the PRC.  Our principal products include spray, ointment, powder, patch, cream, and miscellaneous health and beauty products. Our principal products are categorized as external use Traditional Chinese Herbal Remedies/ Medicines commonly referred to in the industry as “TCM.” We have evolved into an integrated manufacturer, marketer and distributor of external use Chinese medicine products sold primarily in China and through PRC domestic pharmaceutical chains and have been expanding our worldwide sales effort as well.  We sell both our own manufactured products, as well as medicinal and pharmaceutical products manufactured by others in the PRC.   

The Company achieved continuing growth on the sale of both our own product line and a contract service line of manufacturer’s products which we sell through our distribution channel.  For the year ended December 31, 2007, total revenue was $49,318,308, a 148% increased over 2006, and 2007 net income was $15,332,945, or $1.15 per share on a diluted basis compared to net income of $624,415, or $0.05 per share on a diluted basis in 2006.

All of our business is conducted through our wholly-owned subsidiary, ACPG which, in turn, wholly owns Harbin Tian Di Ren Medical Science and Technology Company (referred to herein as “TDR”) a company organized in the PRC and TDR’s subsidiaries, described above and below.

We have also recently organized Harbin Tian Qing Biotech Application Company as a wholly-owned PRC subsidiary of TDR, to conduct research and development in the areas of tissue and stem cell banks, which is described in more detail below.   

On April __, 2008, TDR completed an acquisition pursuant to an Equity Transfer Agreement dated February 22, 2008, between TDR and Heilongjiang Tianlong Pharmaceutical, Inc., a corporation organized under the laws of the PRC (“Heilongjiang”), which is in the business of manufacturing external-use pharmaceuticals. Our TDR subsidiary previously acquired the Beijing sales office of Heilongjiang in mid 2006. Pursuant to the Equity Transfer Agreement, TDR acquired 100% of the issued and outstanding capital stock of Heilongjiang from Heilongjiang’s sole stockholder in consideration for an aggregate of approximately (i) $8,000,000 in cash, and (ii) shares of common stock of the parent company, China Sky One with a dollar value of $300,000.

Tianlong’s Beijing office had revenues of approximately US$1.5 million from January to November of 2006, with 20% in net profits.  We expect sales to increase by 30% in 2007, which means the purchase of Tianlong would increase 2007 sales to approximately US$1.98 million. 

We currently conduct all of our research and development (“R&D”) activities, either internally or through collaborative arrangements with universities and research institutions in the PRC. We have our own research, development and laboratory facilities located at TRD’s principal headquarters in the city of Harbin, Heilongjiang Province. In all, our internal R&D team currently consists of approximately 35 people, of which 25 are full time researchers and 10 are part time technical experts. Many of our team members are professors affiliated with universities in the PRC.

Additionally, we have established several long-term partnerships with well-known universities and enterprises in the PRC. We have built a gene medicine laboratory through a collaborative effort with Harbin Medical University; established a cell laboratory with North East Agricultural University; and founded a monoclonal antibody laboratory with Jilin University. Under our partnership arrangements with other universities and research institutions, we will generally hold the intellectual property rights to any developed technology. As a result of one of these collaborations with Harbin Medical University, a product known as “Endothelin-1” is currently under development as a cancer suppressing product. Additional information relating to this product and other products being developed is set forth under “Products Under Development” below and under the general product descriptions in the “Description of Business” section above, which is incorporated by reference herein .
 
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In collaboration with Harbin Medical University, we have completed a laboratory experimental study pertaining to Endothelin-1, which is required prior to clinical trials, and we are currently applying for approval to enter clinical experiments.  This medicine has been recognized by the PRC as the “Top Category in New Medicine.”  In order to qualify as the “Top Category in New Medicine,” a company must have intellectual property rights, high technology involvement, strong innovation, and the medicine must be the first of its kind to be introduced to the PRC.  We hold the intellectual property rights pertaining to this technology, and we have obtained an invention patent to this intellectual property in the PRC.  Under our partnership arrangements with other universities and research institutions, we will generally hold the intellectual property rights to any developed technology.

At present, our ongoing research is divided into five general areas: (1) the development of an enzyme linked immune technique to prepare extraneous diagnostic kits (see table below); (2) the development of an enzyme linked gold colloid technique to prepare extraneous rapid diagnostic test strip; (3) the development of a gene recombination technique to prepare gene drug; (4) the development of a biology protein chip for various tumor diagnostic applications; and (5) the development of a cord blood stem cell bank, as described under “Item 1. Description of Business.”

We currently have eight biological products under development:   HIV detection kit; a uterus cancer diagnostic kit; a breast cancer diagnostic kit; a liver cancer diagnostic kit; a rectum cancer diagnostic kit; a gastric cancer diagnostic kit; a gene recombination drug; and a multi-tumor marker protein chip detection kit.  We are also working to establish two sales networks and cell banks covering domestic and international markets.

In addition, we also have three products: AMI Diagnostic Kit, Human Urinary Albumin Elisa Kit and Early Pregnancy Diagnostic Kit that have passed the final stages of national inspection in 2006 or 2007. These diagnostic kits are being sold through drug stores, hospitals, examination stations and independent sales agents throughout the PRC.  We also plan to market these products in Vietnam, Indonesia, Philippines and eventually in Africa. (See “Item 1. Description of Business - Biological Products - Examination and Diagnosis Kits”)

Our AMI Diagnostic Kit, which reached markets in 2007, is used for early diagnosis of Myocardial Infarction (MI), also known as heart disease. All the test kits require users to place a blood or urine sample on the marker and a positive (+) or negative (-) reaction signal will result, showing if a user should consult his or her doctor for further testing.  According to the China Medical Newspaper, several million people die from MI every year.  MI often occurs to people who are, but not limited to, smokers, over-weight and diabetic.  There are approximately 8 million new MI patients in China every year.  Recent medical studies have shown that heart failure or heart attacks are increasing among younger people in China.  This is a result from a more modern life style, the fast pace of city life and increased pressure from work or school.  The use of AMI Diagnostic Kits will help in early detection that can help in reducing these statistics.

Our Human Urinary Albumin Elisa Kit is used for early diagnosis of nephropathy, or kidney problems.  According to the China Medical Newspaper, early kidney impairment does not present obvious symptoms, but causes irreversible impairments to the kidney. There are billions of people who suffer from diabetes, hypertension, cardiovascular disease and nephritis all over the world.  We developed this diagnostic kit to inform users of any major changes their kidney may be experiencing.

Our Early Pregnancy Diagnostic Kit uses monoclonal antibody technology to inform users if they are pregnant. With this type of technology, a monoclonal antibody is created to specifically bind to a hormone, Human Chorionic Gonadotropin (HCG), that a pregnant woman produces after conception. This process allows for the detection of pregnancy.  The ability to determine early pregnancy is important in avoiding the absorption of harmful chemicals or drugs that can directly affect an infant.

In March, 2007, we entered into a strategic agreement with Takasima. As a result of this agreement, Takasima has been engaged as the sole agent of China Sky One's patch products in Malaysia.  Takasima has commenced marketing and sales efforts of China Sky One's Slim Patch product line. The Slim Patch is a weight loss product that is currently sold in China under the "Tian Di Ren" brand. The Slim Patch will be repackaged and sold in Malaysia under the "Takasima" brand name. The strategic agreement also requires that Takasima will generate sales revenue of approximately US$1.0 million per month. Since the signing of the agreement, Takasima has fulfilled its monthly obligation. Management anticipates that this strategic agreement could result in up to US$12 million in additional annual sales revenue in 2007, with a net profit margin of approximately 20%. The agreement also provides that Takasima has a first right of refusal to become the sole distributor of the Slim Patch in all of Southeast Asia.
 
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  During the second quarter of 2007, TDR entered into an agreement with the Development and Construction Administration Committee of Harbin Song Bei New Development district to purchase the land use rights for 50 years for development of a new biotech engineering project. Terms of the agreement called for a deposit of 30% of the total land price within 15 days after signing the agreement, 40% payment 7 days prior to the start of construction and the balance 7 days after getting the formal land use right.

The project consists of two phases:
 
(1) Main workshop, R&D center and office using land area of 30,000 square meters, construction started in May 2007 projected to be completed by June 2008.
 
(2) Second workshop and show room using land area of 20,000 square meters, Construction starting in September 2008 to be completed by December 2009.

TDR has committed to the Development and Construction Administration Committee of Harbin Song Bei New Development District that the minimum investment per square meter will be $394.

Significant Accounting Estimates and Policies
 
The discussion and analysis of our financial condition and results of operations is based upon our financial statements which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities. On an on-going basis, we evaluate our estimates including the allowance for doubtful accounts, the salability and recoverability of our products, income taxes and contingencies. We base our estimates on historical experience and on other assumptions that we believes to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
 
Property and equipment are evaluated for impairment whenever indicators of impairment exist. Accounting standards require that if an impairment indicator is present, we must assess whether the carrying amount of the asset is unrecoverable by estimating the sum of the future cash flows expected to result from the asset, undiscounted and without interest charges. If the recoverable amount is less than the carrying amount, an impairment charge must be recognized, based on the fair value of the asset.
 
As part of the process of preparing our consolidated financial statements, we are required to estimate our income taxes. This process involves estimating our current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities. We must then assess the likelihood that our deferred tax assets will be recovered from future taxable income, and, to the extent we believe that recovery is not likely, we must establish a valuation allowance. To the extent that we establish a valuation allowance or increase this allowance in a period, we must include a tax provision or reduce our tax benefit in the statements of operations. We use our judgment to determine our provision or benefit for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets. We believe, based on a number of factors including historical operating losses, which we will not realize the future benefits of a significant portion of our net deferred tax assets and we have accordingly provided a full valuation allowance against our deferred tax assets. However, various factors may cause those assumptions to change in the near term.
 
We cannot predict what future laws and regulations might be passed that could have a material effect on our results of operations. We assess the impact of significant changes in laws and regulations on a regular basis and update the assumptions and estimates used to prepare our financial statements when we deem it necessary.
 
We have determined the significant principles by considering accounting policies that involve the most complex or subjective decisions or assessments. Our most significant accounting policies are those related to intangible assets and research and development.
 
Intangible assets - Intangible assets consist patents, distribution rights and customer lists. Patent costs are being amortized over the remaining term of the patent. Distribution rights and customer lists are being amortized over 10 years.

Intangible assets are accounted for in accordance with Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible Assets (“SFAS 142”).  Intangible assets with finite useful lives are amortized while intangible assets with indefinite useful lives are not amortized. As prescribed by SFAS 142, goodwill and intangible assets are tested periodically for impairment. The Company adopted SFAS No. 144, "Accounting for the Impairment or Disposal of Long- Lived Assets," effective January 1, 2002. Accordingly, the Company reviews its long-lived assets, including property and equipment and finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine recoverability of its long-lived assets, the Company evaluates the probability that future undiscounted net cash flows will be less than the carrying amount of the assets. Impairment costs, if any, are measured by comparing the carrying amount of the related assets to their fair value.
 
33


Research and development—Research and development expenses include the costs associated with the Company’s internal research and development as well as research and development conducted by third parties. These costs primarily consist of salaries, clinical trials, outside consultants, and materials. All research and development costs discussed above are expensed as incurred.  

Third-party expenses were reimbursed under non-refundable research and development contracts, and are recorded as a reduction to research and development expense in the statement of operations.

The Company recognizes in-process research and development in accordance with FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method and the AICPA Technical Practice Aid, Assets Acquired in a Business Combination to be used in Research and Development Activities:  A Focus on Software, Electronic Devices, and Pharmaceutical Industries. Assets to be used in research and development activities, specifically, compounds that have yet to receive new drug approval and would have no alternative use, should approval not be given, are immediately charged to expense when acquired.

For the year ended December 31, 2007, the Company incurred $3,158,351 in research and development expenditures, and $2,026,788 for year 2006.

RESULTS OF OPERATIONS  

Year Ended December 31, 2007 as compared to Year Ended December 31, 2006

Our principal business operations are conducted through our wholly owned subsidiary, Harbin Tian Di Ren Medical Science and Technology Company (“TDR”), and TDR’s subsidiaries.  The results of operations of TDR have been included in the below financial statements since the acquisition date.

 
 
December 31
 
 
 
2007
     
2006
 
REVENUES
 
 
 
Variance 
 
 
 
Product Sales (net of sales allowance)
 
$
36,320,156
   
171
%
$
13,386,223
 
Contract Sales
   
12,998,152
   
104
%
 
6,382,737
 
Government Grant
   
-
         
112,755
 
Total revenues
 
$
49,318,308
   
148
%
$
19,881,715
 
 
             
COST OF GOOD SOLD
             
Cost of good sold
   
10,939,531
   
116
%
 
5,063,084
 
Gross Profit
 
$
38,378,777
   
159
%
$
14,818,631
 

Total sales increased by 148% in 2007 compared to 2006.  The $29,436,593 million increase in sales is attributable to strong performances from our sales distribution channel.

Product sales increased by 171% in the year ended December 31, 2007, to $36,320,156 from $13,386,223 in 2006.  This growth in sales is attributable to volume and continuing efforts to develop our distribution channels by hiring direct territory managers and sales agents to assure that our products and their associated benefits are seen by those making or influencing the purchasing decisions. A new series named Bio-Chemical Products were launched on 2007. It increased the sales amount by $3 million for the year ended December 31, 2007. The company opened the overseas market on this year and the unit selling price is higher than local market. The overseas market generated sales amount of $12.4 million in this year.

Contract and Other Revenue

The following table summarizes the period over period changes in our contract and other revenues:

  
 
2007
 
Change
 
2006
 
Contract and other revenue
 
$
12,998,152
   
104
%
$
6,382,737
 

34

 
Contract and other revenue was $12,998,152 in 2007, or a significant increase of $ 6,615,415 over sales of $6,382,737 in 2006. In 2007, contract and other revenue increased primarily due to net product distribution service revenue from sales of other manufactured brands through our distribution channel, which constitutes approximately 22% of total sales in 2007.

 Cost of Goods Sold and Product Gross Margin
 
 
 
  December 
 
 
 
2007
 
Variance
 
2006
 
Total sales
 
$
49,318,308
   
148
%
$
19,881,715
 
Cost of goods sold
 
$
10,939,531
   
116
%
$
5,063,084
 
Product gross margin
   
78
%
     
75
%

Our product’s gross margin for 2007 was 78%, compared to 75% for 2006. The increased gross margin was primarily due to the overseas sales that had a profit margin around 80%. The profit margin of local sales was stable compared to last year’s.

Selling, General and Administrative Expenses.
 
The following table summarizes the period over period changes in our selling, general and administrative (SG&A) expenses over the last two years:

 
 
December 31
 
 
 
2007
 
Variance
 
2006
 
Operating Expenses
 
 
 
 
 
 
 
R&D Expenses
 
$
3,158,351
   
56
%
$
2,026,788
 
General, administrative and selling expenses
   
16,163,577
   
51
%
 
10,738,285
 
Depreciation and amortization
   
443,063
   
265
%
 
121,522
 
Total operating expenses
   
19,764,991
   
53
%
 
12,886,595
 
 
             
Other Income (Expenses)
             
Other income
   
48,889
         
-
 
Interest expense
   
(10,557
)
       
(227,857
)
Total other income (expenses)
 
$
38,332
     
$
(227,857
)

Gross sales increased approximately $29,436,593 million in 2007 and corresponding, selling, general and administrative expenses (“SG&A”) for 2007 increased by $5,425,292 over 2006. Selling expenses increased significantly due to the increase of sales. Advertising expenses increased by $2,808,264 to $4,385,045, or 178%, in 2007 from $1,576,781 in 2006. Salaries, commissions, and incentives paid to sales persons increased 122% in 2007 compared to 2006. General and administrative expenses increased 50% compare to 2006.
 
Research and development (“R&D”) expenses were $3,158,351 for 2007 compared to $2,026,788 for 2006.  We anticipate R&D expenses will increase as we conduct additional clinical trials and seek out additional patents and claims for our products.

Finance costs decreased by $217,300 from 2006, primary due to the paid off of the short term notes in 2007.

LIQUIDITY AND CAPITAL RESOURCES

The following table summarizes our cash, cash equivalents and marketable securities, our working capital, and our cash flow activity as of the end of, and for each of, the last two years:

   
December 31
 
 
 
2007
 
2006
 
Cash, cash equivalents and marketable securities
 
$
9,190,870
 
$
6,586,800
 
Working capital
 
$
15,447,162
 
$
7,797,928
 
 
         
Year Ended December 31:
         
Cash provided by (used in):
         
Operating activities
 
$
11,601,480
 
$
5,182,539
 
Investing activities
 
$
(10,260,933
)
$
(4,596,507
)
Financing activities
 
$
(32,516
)
$
2,930,832
 
 
35


 
As of December 31, 2007, cash and cash equivalents were $9,190,870 , an increase of 40% over December 31, 2006. The increase of $ 2,604,070 in 2007 was primarily due to: an increase net income of $14.7 million, and increase of accounts payable balance of $2.0 million and effect of the foreign currency translation of $1.3 million. The increase was partially offset by an increase of accounts receivable of $7.5 million and land deposit prepayment of $8.0 million.

The Company’s current ratio at December 31 was 4.06, and quick ratio was 3.99.  Its primary sources of funds include cash balances, cash flow from operations, and potentially the proceeds of borrowing and sales of equity.  Management endeavors to ensure that funds are available to take advantage of new investment opportunities and that funds are sufficient to meet future liquidity and capital needs.  Management considers current working capital and borrowing capabilities adequate to cover the Company's current operating and capital requirements.

There was no restrictive bank deposit pledged as of December 31, 2007. Therefore, the Company did not have to maintain any minimum balance in the relevant deposit account as security.

Cash flows provided by operating activities were $11.60 million for the year ended December 31, 2007 compared to cash provided by operating activities of $5.18 million for the comparable 2006 period. The increase in cash provided by operating activities of $6.42 million was attributable primarily to the longer accounts receivable collection period compared to year ended December 31, 2006.

Working capital at December 31, 2007 was $15.4 million, compared to $7.8 million at December 31, 2006. Significant factors that resulted in an increase in 2007 working capital were: a $2.6 million increase in cash, cash equivalents, and a $7.5 million increase in accounts receivable primarily due to increased sales of $40.5 million in 2007.

These increases were partially offset by:  a $1.0 million increase in income taxes payable primarily due to higher profitability; a $2.0 million increase in accounts payable, and other accrued liabilities including increases in accruals in wages.

Inventories increased by $93,110 to $371,672 as of December 31, 2007, from $278,562 as of December 31, 2006.  The Company has a small inventory on hand primarily due to the enhanced productivity of newly purchased equipment and machinery, and the popularity of Company products in the market.
 
Year Ended December 31, 2006 as compared to Year Ended December 31, 2005
  
 
 
December 31
 
 
 
2006 
 
 
 
2005
 
REVENUES
      
Variance
      
Product Sales (net of sales allowance)
 
$
13,386,223
   
78.42
%
$
7,502,682
 
Contract Sales
   
6,382,737
   
101975
%
 
6,253
 
Government Grant
   
112,755
   
-44.38
%
 
202,706
 
Total revenues
 
$
19,881,715
       
$
7,711,641
 
 
                   
COST OF GOOD SOLD
                   
Cost of good sold
   
5,063,084
   
129
%
 
2,213,667
 
Gross Profit
 
$
14,818,631
   
170
%
$
5,497,974
 

36

 
Total sales increased by 158% in 2006 compared to 2005.  The $12.17 million increase in sales is attributable to strong performances from our sales distribution channel, as well as the addition of a new line of contract sale service in 2006 to sell other manufactured brands through our distribution channel.  

Product sales increased by 78.42% in the year ended December 31, 2006, to $13,386,233 from $7,502,682 in 2005.  This growth in sales is attributable to volume and continuing efforts to develop our distribution channels by hiring direct territory managers and sales agents to assure that our products and their associated benefits are seen by those making or influencing the purchasing decisions.

Government grant was recognized of $112,755 in 2006 compared to $202,706 in 2005. The government grant was issued to support our research and development, and the production of new medicines.  The grant is recognized as income over the period necessary to match the related costs.  This decrease in government grant received was also due to the expansion in our size and an increase in revenue and capital which made us less qualified for certain government grant that are issued to small businesses.
 
Contract and Other Revenue
 
The following table summarizes the period over period changes in our contract and other revenues:

  
 
2006
 
Change
 
2005
 
Contract and other revenue
 
$
6,382,737
   
101975
%
$
6,253
 

Contract and other revenue was $6,382,737 in 2006, or a significant increase of $6,376,484 over nominal sales of $6,253 in 2005. In 2006, contract and other revenue increased primarily due to net product distribution service revenue from sales of other manufactured brands through our distribution channel, which constitutes approximately 32% of total sales in 2006.
 
 Cost of Goods Sold and Product Gross Margin
 
The following table summarizes the period over period changes in our product sales and cost of goods sold and product gross margin:
 
 
 
2006
 
Variance
 
2005
 
Total sales
 
$
19,881,715
   
158
%
$
7,711,641
 
Cost of goods sold
 
$
5,063,084
   
129
%
$
2,213,667
 
Product gross margin
   
75
%
       
71
%

Our product gross margin for 2006 was 75%, compared to 71% for 2005. The lower gross margin was primarily due to the launch of a new sales line of other manufactured brands through our distribution channel, the gross margin for this contract service line is around 80% with a corresponding impact to our product gross profit.
 
Operating Expenses.
 
The following table summarizes the period over period changes in our operating and interest expenses over the last two years:

 
 
December 31
 
 
 
2006
 
Variance
 
2005
 
Operating Expenses
 
 
 
 
 
 
 
R&D Expenses
 
$
2,026,788
   
3079
%
$
63,749
 
General and administrative expenses
   
10,738,303
   
268
%
 
2,914,190
 
Depreciation and amortization
   
121,522
   
111
%
 
57,563
 
Total operating expenses
 
$
12,886,595
       
$
3,035,502
 
 
                   
Interest expense
 
$
227,857
   
1197
%
$
17,563
 
 
Gross sales increased approximately $12.17 million in 2006, and corresponding, selling, general and administrative expenses (“SG&A”) for 2006 increased by $7,824,095 over 2005. Higher expenses were primarily driven by higher headcount which increased compensation and benefits by $1.12 million including employee stock-based compensation expense of $65,604 from our adoption of SFAS 123R on January 1, 2006.  In addition, this increase is attributable to an increase in advertising costs of $648,225; $2.5 million related to a general expansion of our sales and marketing activities; our promotional program relating to our business growth; business development activities; and the sales force expansion planned for the anticipated launch in our new contract service line.  The increase in SG&A was also impacted by the inclusion of approximately of $1.8 million in professional and advisory fees related to the reverse merger with Comet.
 
37

 
Research and development (“R&D”) expenses were $2,026,788 for 2006 compared to $63,749 for 2005.  We anticipate R&D expenses will increase as we conduct additional clinical trials and seek out additional patents and claims for our products.

Finance costs increased by $210,299 from 2005, associated with bank loans of $511,642 and preferential conversion feature expense of $177,803.   
 
LIQUIDITY AND CAPITAL RESOURCES
 
The following table summarizes our cash, cash equivalents and marketable securities, our working capital, and our cash flow activity as of the end of, and for each of, the last two years:
 
 
 
2006
 
2005
 
As of December 31:
 
 
 
 
 
Cash, cash equivalents and marketable securities
 
$
6,586,800
 
$
2,937,333
 
Working capital
   
7,797,928
   
2,935,221
 
 
             
Year Ended December 31:
             
Cash provided by (used in):
             
Operating activities
   
5,182,539
   
1,089,769
 
Investing activities
   
(4,596,507
)
 
(776,488
)
Financing activities
   
2,930,832
   
590,635
 

As of December 31, 2006, cash and cash equivalents were $6,586,800, an increase of 124% over December 31, 2005. The increase of $3,649,467 in 2006 was primarily due to: an approximately $5.18 million was generated from operations in China tax jurisdictions; net proceeds generated from a private common stock issuance of $2,715,000, and notes of $215,832.  These increases were partially offset by capital expenditures of $4.23 million in 2006.

The Company’s current ratio at December 31 was 4.29, and quick ratio was 4.17.  Its primary sources of funds include cash balances, cash flow from operations, and potentially the proceeds of borrowing and sales of equity.  Management endeavors to ensure that funds are available to take advantage of new investment opportunities and that funds are sufficient to meet future liquidity and capital needs.  Management considers current working capital and borrowing capabilities adequate to cover the Company's current operating and capital requirements.

There was no restrictive bank deposit pledged as of December 31, 2006. Therefore, the Company did not have to maintain any minimum balance in the relevant deposit account as security.

Our total outstanding liabilities were $2.37 million as of December 31, 2006.

Cash flows provided by operating activities were $5.18 million for the year ended December 31, 2006 compared to cash provided by operating activities of $1.09 million for the comparable 2005 period. The increase in cash provided by operating activities of $4 million was attributable primarily to sales growth, which is also enhanced by a $1.94 million increase in accounts receivable, and offset by increased inventories of approximately $103,000 plus an increase of approximately $0.7 million increase in accounts payable and accrued expenses.

Working capital at December 31, 2006 was $7.8 million, compared to $2.94 million at December 31, 2005. Significant factors that resulted in an increase in 2006 working capital were: a $3.65 million increase in cash, cash equivalents; a $1.70 million of non cash share-based compensation; and a $1.94 million increase in accounts receivable primarily due to increased sales of $12.26 million in 2006, offset by higher collection activity.
 
These increases were partially offset by:  a $420,795 increase in income taxes payable primarily due to higher profitability; a $1,688,896 increase in liabilities reflecting the share-based compensation pursuant to the requirement of SFAS 123R; a $519,531 increase in accounts payable, and other accrued liabilities including increases in accruals in wages.
 
38


Accounts receivables increased by $1,940,913 or 154% to $3,199,026 as of December 31, 2006, compared to $1,258,113 as of December 31, 2005.  This increase is primarily due to an increase in sales of $12,260,025.  More than ninety percent of the Company’s receivables are aged less than 90 days.

Inventories decreased by $102,578 to $278,562 as of December 31, 2006, from $381,140 as of December 31, 2005.  The Company has a small inventory on hand primarily due to the enhanced productivity of newly purchased equipment and machinery, and the popularity of Company products in the market.
 
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
As of December 31, 2007, the Company had no material derivative instruments. The Company may enter into derivative financial instrument transactions in order to mitigate its interest rate risk on a related financial instrument in the future.

Our balance sheet includes amount of assets and liabilities whose fair values are subject to market risk. Market risk is the risk of loss arising from adverse changes in market prices or interest rates. Generally, the Company’s borrowing is short to medium term in nature and therefore approximates fair value. The Company currently has interest rate risk as it relates to its fixed maturity mortgage participation interest. The Company seeks to limit the impact of interest rate changes on earnings and cash flows and to lower its overall borrowing costs by closely monitoring its interest rate debt.

The Company has certain equity risks as it relates to its marketable equity securities, and foreign currency risks as it relates to investments denominated in foreign currencies. The Company and its subsidiaries are mainly located in China, and there were no significant changes in exchange rates, during the reported periods.  However, unforeseen developments may cause a significant change in exchange rates.  The Company is subject to commodity price risks arising from price of construction materials.

The Company is subject to market and channel risks. Over 90% of the Company’s sales are made in the PRC, where the Company primarily sells its products through drug chain stores. Because of this, the Company is dependent to a large degree upon the success of that distribution channel as well as the success of specific retailers in the distribution channel. Many of the drug stores are individual stores or very small chains, and only a few are large chain drug stores.  The Company relies on these distribution channels to purchase, market, and sell its products.  The Company’s success is dependent, to a large degree, on the growth and success of the drug stores, which may be outside its control. There can be no assurance that the drug store distribution channels will be able to grow or prosper as it faces price and service pressure from other channels, including the mass market.  There can be no assurance that retailers in the drug store distribution channel, in the aggregate, will respond or continue to respond to the Company’s marketing commitment in these channels.
 
The Company is highly dependent upon the public perception and quality of its products, consumers’ perception of the safety and quality of its products, as well as similar products distributed by other companies.  Thus, the mere publication of reports asserting that such products may be harmful could have a material adverse effect on the Company, regardless of whether these reports are scientifically supported.  Adverse publicity may have a material adverse effect on the Company’s business, financial condition, and results of operations.  There can be no assurance of future favorable scientific results and media attention, or of the absence of unfavorable or inconsistent findings.
 
Currency Exchange Fluctuations
 
All of Company’s revenues and majority of the expenses in 2007 were denominated primarily in Renminbi (“RMB”), the currency of China, and was converted into US dollars at the exchange rate of 7.006 RMB to 1 U.S. Dollar. In the third quarter of 2005, the Renminbi began to rise against the US dollar. There could be no assurance that RMB-to-U.S. dollar exchange rates will remain stable. A devaluation of RMB relative to the U.S. dollar would adversely affect our business, financial condition and results of operations. We do not engage in currency hedging.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that are currently material or reasonably likely to be material to our financial position or results of operations.
 
39


MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information - Common stock

Our common stock (“Common stock”) is traded on the OTC Bulletin Board under the symbol “CSKI.”  The range of high and low sales prices for each quarter during the last two fiscal years, as quoted on the OTC Bulletin Board for the periods discussed above, is set out in the table that follows. These quotations reflect inter-dealer prices, without retail mark-up, mark-down, or commission and may not necessarily represent actual transactions.

 
 
Year Ended December 31, 2007
 
Year Ended December 31, 2006
 
 
 
High
 
Low
 
High
 
 Low
 
1st Quarter
 
$
10.00
 
$
7.00
 
$
5.50
 
$
1.81
 
2nd Quarter
 
$
14.20
 
$
6.00
 
$
3.50
 
$
3.50
 
3rd Quarter
 
$
14.35
 
$
10.00
 
$
7.55
 
$
3.40
 
4th Quarter
 
$
15.50
 
$
9.00
 
$
8.50
 
$
4.25
 
 
As of March 26, 2008, the closing bid price for our Common stock was $10.20.  

Since its inception, no dividends have been paid on our Common stock.   We intend to retain any earnings for use in our business, so it is not expected that any dividends on the Common stock will be declared and paid in the foreseeable future.    We do not currently have any restrictions that would limit our ability to pay dividends, and we are not currently aware of any restrictions that are likely to limit our ability to pay dividends in the future.   

At March 20, 2008, there were approximately 431 holders of record of the Company's Common stock, with 14,852,214 shares outstanding.

EQUITY COMPENSATION PLAN INFORMATION

 
 
(a)
 
(b)
 
(c)
 
Plan Category
 
Number of securities to be issued upon exercise of outstanding options, warrants and rights
 
Weighted-average exercise price of outstanding options, warrants and rights
 
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
 
Equity compensation plans approved by security holders (1)
   
113,500
   
3.65
   
1,386,500
 
Equity compensation plans not approved by security holders (2)
   
None
   
n/a
   
-0-
 
Total
   
113,500
   
n/a
   
1,386,500
 

(1)   The Company’s board of directors adopted a 2006 Stock Incentive Plan (the “Plan”), to be effective on July 31, 2006.   The Plan was approved by the shareholders on July 31, 2006.
 
(2)   We do not have any equity compensation plans not approved by the security holders.
 
40

 
Sales of Unregistered Securities
 
On January 31, 2008 China Sky One entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors, for the purchase and sale of units consisting of: (i) one (1) share of the Company’s common stock, $.001 par value per share (“Common stock”); and (ii) 750,000 Class A Warrants exercisable at $12.50 per share, and expiring on July 31, 2011 (the “Class A Warrants”), for a purchase price of $10.00 per Unit (the “January 2008 Offering”), and gross offering proceeds of $25,000,000.
 
Holders of the 2,500,000 shares of common stock sold in our January 2008 Offering have certain put rights and rights to receive additional shares from the Company if we sell low priced securities or from certain key shareholders in the event that certain thresholds are not met, in addition to registration rights. Specifically, these investors have:
 
 
·
The right to receive additional shares of common stock from China Sky One in the vent that we sell shares (or convertible securities or warrants convertible into or exercisable for common stock) prior to January 31, 2009 at per share price (or exercise or conversion price) of less than $10.00, in such amount so as to reduce the average price paid by such shareholder to the price per share being paid by the new investors,
 
 
·
The right to receive up to 3,000,000 shares deposited into escrow by our principal shareholder, in the event that the Company fails to attain Earnings Per Share, as adjusted of at least (i) $1.05 per share for fiscal year ended December 31, 2007 based on fully diluted shares outstanding before the January 2008 offering (an aggregate of 13,907,696), and/or (ii) $1.75 per share for fiscal year ending December 31, 2008 based on fully diluted shares outstanding after the January 2008 Offering (an aggregate of 16,907,696 shares). While the Company has satisfied the criterion of (i) above for 2007, no assurance can be made that we will satisfy our earnings goal next year.

The Class A Warrants represent the right to purchase an aggregate of 750,000 shares of common stock, at an exercise price of $12.50 per share, and have the following additional characteristics:
 
 
·
The Class A Warrants are exercisable beginning on the six-month anniversary of the closing of the January 2008 Offering and will expire July 31, 2011.
 
 
·
Commencing on one-year anniversary of the Closing Date, in the event the Warrant Shares may not be freely sold by the holders of the Class A Warrants due to the Company’s failure to satisfy its registration requirements, and an exemption for such sale is not otherwise available to the Warrant-holders under Rule 144, the Class A Warrants will be exercisable on a cashless basis.
 
 
·
The Exercise Price and number of Warrant Shares will be subject to adjustment for standard dilutive events, including the issuance of Common stock, or securities convertible into or exercisable for shares of Common stock, at a price per share, or conversion or exercise price per share less than the Class A Warrant exercise price of $12.50 per share.
 
 
·
At anytime following the date a Registration Statement covering the Warrant Shares is declared effective, we will have the ability to call the Class A Warrants at a price of $0.01 per Class A Warrant, upon thirty (30) days prior written notice to the holders of the Class A Warrants, provided (i) the closing price of the Common stock exceeded $18.75 for each of the ten (10) consecutive trading days immediately preceding the date that the call notice is given by the Company, and (ii) the Company has attained an Adjusted EPS of at least $1.75 per share for the fiscal year ending December 31, 2008, as set forth in our audited financial statements of the Company.
 
 
·
If, among other things, we fail to cause a Registration Statement covering the Warrant Shares to be declared effective prior to the applicable dates set forth in the Registration Rights Agreement, the expiration date of the Class A Warrants shall be extended one day for each day beyond the Effectiveness Deadlines.
 
 
·
If a Warrant-holder exercises its Put Right under the Put Agreement (defined in Item 1.01 above), such Warrant-holder’s right to exercise the Class A Warrants shall be suspended, pending the satisfaction of our obligations to pay the Warrant-holder the applicable Repurchase Price. Upon receipt of the Repurchase Price in full by the Warrant-holder, the Warrant-holder’s right to exercise the Class A Warrants shall automatically and permanently terminate and expire, and the Class A Warrants shall be immediately cancelled on the books of the Company.

41


USE OF PROCEEDS

Each of the selling securityholders will receive all of the net proceeds from the sale of shares by that securityholder. We will not receive any of the net proceeds from the sale of the shares. The selling securityholders will pay any underwriting discounts and commissions and expenses incurred by the selling securityholders for brokerage, accounting, tax or legal services or any other expenses incurred by the selling securityholders in offering or selling their shares. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares covered by this prospectus, including, without limitation, all registration and filing fees, OTC Bulletin Board fees, blue sky registration and filing fees, and fees and expenses of our counsel and accountants.

A portion of the shares covered by this prospectus are, prior to their sale under this prospectus, issuable upon exercise of Class A warrants. Upon the exercise of warrants by payments of cash, we will receive the exercise price of the warrants, which, subject to any future adjustment, is currently $12.50 per share. To the extent that we receive cash upon the exercise of the warrants, we expect to use that cash for general corporate purposes.

DILUTION

We are not selling any of the shares of common stock in this offering. All of the shares sold in this offering will be held by the selling securityholders at the time of the sale, so that no dilution will result from the sale of the shares. However, in the event that any or our warrants which are exercisable at below market prices are exercised, shareholders will suffer dilution.
 
42

 
SELLING SECURITYHOLDERS

The following table presents information regarding the selling securityholders based upon information furnished by them.

In accordance with various agreements, we have agreed with the selling securityholders to register shares of common stock presently owned by them. Our registration of the shares does not necessarily mean that the selling securityholders will sell all or any of the shares, however, the following table assumes that all shares registered will be sold.

The shares offered by this prospectus may be offered from time to time by the selling securityholders listed in the following table. Each selling securityholder will determine the number of shares to be sold and the timing of the sales. Because the selling securityholders may offer all, some or none of their shares, no definitive estimate as to the number of shares thereof that will be held by the selling securityholders after such offering can be provided, and the following table has been prepared on the assumption that all shares of common stock offered under this prospectus will be sold

In addition to the 2,860,835 already outstanding shares of common stock held by selling securityholders that are being registered for resale hereby, the following additional shares which may be issued upon exercise of warrants are being registered for resale by the selling securityholders in this registration statement:

 
·
750,000 shares issuable upon exercise of Class A Warrants to purchase, at an exercise price of $12.50 per share, issued to investors in connection with our private offering in January 2008, exercisable between July 31, 2008 and July 31, 2011,
 
 
·
239,168 shares issuable upon exercise of callable warrants at $3.50 per share (originally, 500,003 callable warrants, many of which have been exercised, the underlying shares of which are being registered hereby) and expiring October 10, 2008 (the “Callable Warrants”), held and being resold by certain investors in our private offering of securities in October of 2006,
 
·
50,000 shares of common stock issuable upon exercise of warrants issued to Mr. Jack M. Gertino, a former executive of the Company, at $3.00 per share and expiring December 23, 2008 (the “Consulting Warrants”), and
 
  · 50,000 shares of common stock issuable upon exercise of warrants issued to American Eastern Securities, Inc. (and its assigns), exercisable at $3.50 per share and expiring on October 10, 2008 (the “AES Offering Warrants”). The selling securityholders purchased their shares or, in some cases, were issued their shares in exchange for services rendered, all in private placements.
   
     
Shares Beneficially Owned Prior
to Offering
   
Number of
Shares
         
Shares Beneficially Owned
After Offering
 
Name
   
Number
         
Percent
   
Offered
         
Number
   
Percent
 
Abington Company Ltd. (2) (1)
   
100,000
   
(2) (1)
       
100,000
   
(2) (1)
 
-0-
   
-0-
 
Dominic Jr. and Virginia Albo(2)
   
2,500
   
(2)
       
2,500
   
(2)
       
-0-
 
Alder Capital Partners I LP(3)
   
136,500
   
(3)
  %  
136,500
   
(3)
 
-0-
   
-0-
 
Alder Offshore Master Fund LP(4)
   
58,500
   
(4)
  %  
58,500
   
(4)
 
-0-
   
-0-
 
Bilau, LLC (2) (5)
   
8,334
   
(2) (5)
       
8,334
   
(2) (5)
 
-0-
   
-0-
 
Brummett Family Trust, John B and Nancy Brummett TTEE (2) (6)
   
2,500
   
(2)(6)
       
2,500
   
(2(6)
 
-0-
   
-0-
 
Byron B. Barkley IRA (2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Kenneth Block (2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
James T. and Katy H. Chang JTTEN (2)
   
15,000
   
(2)
       
15,000
   
(2)
 
-0-
   
-0-
 
Dong Feng Chen (2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Julie Hsu Chen (2)
   
15,000
   
(2)
       
15,000
   
(2)
 
-0-
   
-0-
 
Wei Qiang Chen (2)
   
10,000
   
(2)
       
10,000
   
(2)
 
-0-
   
-0-
 
Michael Chu (2)
   
5,317
   
(2)
       
5,317
   
(2)
 
-0-
   
-0-
 
Clearview Investments LTD(7)
   
65,000
   
(7)
       
65,000
   
(7)
 
-0-
   
-0-
 
Rene V. and Jacqueline J. Cote JTTEN(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Mike Crawford (8)
   
6,500
   
(8)
       
6,500
   
(8)
 
-0-
   
-0-
 
Denison Casing Corp Def Ben Pen Pi & Trust UA(2) (9) 
   
5,000
   
(2) (9)
       
5,000
   
(2) (9)
 
-0-
   
-0-
 
Michael S. Done(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Joseph S. and Betty A. Franey JTTEN(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
James Gaddis IRA(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Jack M. Gertino(10)
   
50,000
   
(10)
       
50,000
   
(10)
 
-0-
   
-0-
 
Jeff M. and Mary Jane Gertino JTTEN(2)
   
10,000
   
(2)
       
10,000
   
(2)
 
-0-
   
-0-
 
Guerilla Partners LP(11)
   
130,000
   
(11)
       
130,000
   
(11)
 
-0-
   
-0-
 
 
43

 
 
     
Shares Beneficially Owned Prior
to Offering
   
Number of
Shares
         
Shares Beneficially Owned
After Offering
 
     
Number
         
Percent
   
Offered
         
Number
   
Percent
 
Kenneth Hankawa(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Heller Capital Investments(12)
   
78,000
   
(12)
       
78,000
   
(12)
 
-0-
   
-0-
 
Derrick Ho(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Clayton S. Hovivian(2)
   
15,000
   
(2)
       
15,000
   
(2)
 
-0-
   
-0-
 
Jack Hsieh(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Hua-Mei 21st Century Partners, LP(13)
   
195,000
   
(13)
       
195,000
   
(13)
 
-0-
   
-0-
 
Investment Hunter, LLC(14)
   
195,000
   
(14)
       
195,000
   
(14)
 
-0-
   
-0-
 
Jayhawk Private Equity Co-Invest Fund, LP(15)
   
1,925
   
(15)
       
1,925
   
(15)
 
-0-
   
-0-
 
Jayhawk Private Equity Fund, LP(16)
   
30,575
   
(16)
       
30,575
   
(16)
 
-0-
   
-0-
 
Jeli Properties, LLC (2)(17)
   
7,500
   
(2) (17)
       
7,500
   
(2) (17)
 
-0-
   
-0-
 
J.M.G. Corporation (2) (18)
   
7,500
   
(2) (18)
       
7,500
   
(2) (18)
 
-0-
   
-0-
 
Hui-Lan Lee(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Jian Ping Li(2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Jin Chun (2)
   
5,000
   
(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Lian Xiao Li(2)
   
5,000
   
2(2)
       
5,000
   
(2)
 
-0-
   
-0-
 
Peter Shih-Hsiang and Melissa Pi-Chuan Liao JTTEN(2)
   
8,334
   
(2)
       
8,334
   
(2)
 
-0-