According to Frost & Sullivan, the global autoimmune disease drug market is expanding steadily, estimated to increase from US$138.9 billion in 2024 to US$176.7 billion in 2030, with a CAGR of 4.1%. By contrast, China’s market demonstrates explosive growth momentum. The market size in China is estimated to surge from US$5.1 billion in 2024 to US$19.0 billion in 2030, with a remarkable CAGR of 24.5%, far outpacing the global average and embracing vast market opportunities.

LongBio Pharma (Suzhou) Co., Ltd. ("Longbio Pharma" or the "Company", Stock Code: 01779.HK), a leading player in the sector, officially launched its Public Offering on 28 May, marking the final countdown to its Hong Kong listing. The Company is poised to embark on a new chapter of commercialisation and scaled development empowered by the capital market. 

Focused on Premium Therapeutic Track, Premium Innovative Pipeline Builds Core Barriers

Founded in 2020, Longbio Pharma is a clinical-stage innovative biopharmaceutical company with full in-house capabilities for drug discovery and development, focusing on allergic and autoimmune diseases. Since inception, the Company has consistently prioritised unmet clinical needs and specialised in differentiated innovative tracks, building a well-structured, tiered and high-potential innovative product pipeline.

The Company has established a three-tier product layout featuring breakthrough core product + leading flagship product + robust pipeline reserves. Its portfolio includes core product LP-003 and flagship product LP-005, alongside multiple innovative drug candidates covering high-value indications such as allergic diseases and complement-mediated autoimmune diseases, underpinning promising long-term growth prospects.

Longbio Pharma’s core product LP-003 is a differentiated Anti-IgE monoclonal antibody with an innovative sequence design. It precisely targets the core pathogenesis of allergic diseases, indicated for the targeted treatment of seasonal allergic rhinitis (AR), chronic spontaneous urticaria (CSU), allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and food allergies. Its primary function is to specifically block free IgE in human blood and tissues, and thus inhibiting the occurrence of IgE-driven allergic reactions.

Compared with conventional therapies, LP-003 efficiently binds to free IgE and prohibits those excessive IgEs from binding to the high-affinity IgE receptor, FcεRI. Boasting a precise mechanism of action, strong targeting capability and a broad spectrum of indications, it delivers distinct competitive edges and substantial market potential. 

Clinical data have fully validated its robust product strength. As at the Latest Practicable Date, Longbio Pharma has initiated eight clinical trials in China for LP-003, of which two have been completed and the other six are still ongoing. Top-line results from the Phase II clinical trial for CSU showed that LP-003 demonstrated promising efficacy (fast onset of action, good efficacy and long-acting) compared to omalizumab in the treatment of CSU. LP-003 also showed favorable efficacy and safety profile in its Phase II clinical trial for moderate-to-severe seasonal AR that is inadequately controlled by standard treatment. A Phase III clinical trial for the treatment of seasonal AR is currently underway in China.

With the steady advancement of clinical trials and continuous release of key clinical data, LP-003 is expected to reshape the treatment landscape for allergic diseases and fill the domestic market gap for high-efficiency, long-acting differentiated anti-IgE drugs. Upon commercialisation, it is set to capture a substantial share of the allergic disease treatment market and become a core driver of the Company’s performance growth.

LP-005, the Company’s flagship product, is the first innovative drug developed on its Bi-functional Antibody Development Platform and a bi-functional antibody fusion protein targeting C5 and C3b complement. By acting on multiple key nodes in the complement cascade simultaneously, it comprehensively blocks complex pathological mechanisms of diseases and achieves synergistic multi-pathway inhibition. Outperforming conventional single-target drugs in therapeutic potential and indication coverage, it boasts prominent technological and clinical value.

LP-005 has obtained IND approvals in China for various indications, including paroxysmal nocturnal hemoglobinuria (PNH), complement-mediated kidney diseases (including but not limited to IgAN, C3G and LN), and other complement related indications, covering a range of major diseases with high clinical demand and limited curative options.

The Company is steadily advancing several clinical trials of LP-005 for PNH and complement-mediated kidney diseases. Interim data from Phase II clinical trial (CTR20242478) have yielded encouraging results. From the data collected, LP-005 has shown encouraging efficacy in PNH patients, including two PNH patients who were previously treated with omalizumab but inadequately controlled, still have benefitted continuously from LP-005 treatment throughout the trial period. LP-005 demonstrated favorable safety and tolerability in the Phase I study in China involving healthy subjects, laying a solid foundation for subsequent large-scale clinical development and commercial application.

With continuous breakthroughs in clinical trials, LP-005 is expected to become China’s first novel multi-target complement drug, filling the huge unmet medical need for refractory autoimmune diseases and securing a first-mover advantage in the complement inhibitor segment. It will open up a new growth curve for the Company.

While advancing its core and flagship products, Longbio Pharma continues to expand its pipeline reserves to sustain long-term growth. The Company has developed multiple promising candidates, including LP-00A, a bi-functional autoimmune antibody targeting allergic diseases, LP-00C, a bi-functional B-cell inhibitor targeting B-cell mediated autoimmune diseases and LP-00D, a bi-functional antibody or fusion protein complement inhibitor optimized for specific tissues/organs and indications. The diversified pipelines currently in development precisely target segmented disease areas, forming a rich and diverse pipeline that underpins the Company’s sustained innovation and steady growth.

Self-developed Technology Platforms Empower R&D Strength for Long-term Innovation

Innovative technology platforms are the cornerstone for biopharmaceutical enterprises to continuously deliver high-quality pipelines. With years of expertise in innovative drug R&D, Longbio Pharma has built two proprietary, industry-leading technology platforms: the High-Affinity Antibody Discovery Platform and the Bi-functional Antibody Development Platform. Supported by standardised and systematic R&D workflows, the platforms empower the entire process of candidate drug early discovery and structural optimisation, establishing a solid technical barriers.

The two core R&D platforms cover key links across the biologic drug development value chain. They enable early identification and mitigation of potential risks in clinical development and industrial production. Leveraging platform strengths, the Company efficiently screens high-value candidates with clinical value, cost advantages and commercial potential, achieving optimal allocation of R&D resources and sustainable delivery of premium pipeline products.

The High-Affinity Antibody Discovery Platform features industry-leading antibody screening and optimisation capabilities. Compared with conventional R&D technologies, it significantly enhances the targeting affinity, specificity and stability of antibody drugs. LP-003, developed via this platform, achieves iterative superiority over traditional analogue drugs in efficacy and targeting performance, validating the platform’s technological advancement and reliability.

The Bi-functional Antibody Development Platform breaks the structural limitations of conventional single-target antibodies. It features structural flexibility, broad applicability, high druggability and strong scalability, enabling rapid development of multi-target and multi-mechanism innovative drugs to address complex autoimmune conditions. Pipeline candidates including LP-005, LP-00A, LP-00C and LP-00D are all developed on this platform, demonstrating its robust sustainable output capacity.

Backed by its proprietary core technology platforms, Longbio Pharma has built an proprietary innovative drug R&D system, covering target discovery, molecular optimisation, preclinical research and clinical development. The Company has achieved full independence in R&D and freed itself from external technological reliance. Supported by favourable industry policies, expanding market demand and continuous technological breakthroughs, the Company’s pipeline value keeps unlocking with clear growth logic and strong momentum.

Overall, Longbio Pharma is strategically positioned in the high-growth autoimmune and allergy track. With a portfolio of differentiated core candidates and self-built cutting-edge R&D platforms, it has established solid and profound competitive barriers.

Following its Hong Kong listing, the Company will leverage capital market resources to accelerate the translation of innovative achievements and expand industrial boundaries. It is well-positioned to continuously capture market opportunities in segmented sectors, fully unlock growth potential and boast promising long-term development prospects.