中国抗体(03681) - 2025 - 中期财报

Company Information This section provides key corporate details including board composition, administrative services, and professional advisors Board of Directors and Management This chapter details the board of directors' composition, including executive, non-executive, and independent non-executive directors, and reports changes during the period - Executive Directors include Dr. Liang Ruian (Chairman and CEO) and Mr. Wang Shanchun (President, China Region)[3] - Mr. Wang Shanchun ceased to be President, China Region from June 6, 2025, and resigned as an Executive Director from June 9, 2025[3] - Independent Non-executive Director Mr. Dylan Carlo TINKER passed away on May 29, 2025; Ms. Li Zhixiu and Mr. Shen Nan were appointed as Independent Non-executive Directors on June 30, 2025[3] Corporate Administration and Professional Services This chapter outlines key administrative and professional services, including company secretary, authorized representatives, registered office, auditor, and legal counsel - The Company Secretary is Ms. Chow Yuk Yin, and Authorized Representatives are Dr. Liang Ruian and Mr. Hua Jianping[4] - The Auditor is Ernst & Young; Legal Counsel includes DeHeng Law Offices (Hong Kong) LLP (Hong Kong Law) and Zhong Lun Law Firm (PRC Law)[4] - The company's registered office is located in Hong Kong Science Park, with stock code 3681[4] Chairman's Statement This statement highlights the company's strategic growth, core drug pipeline advancements, financing activities, and strategic collaborations Business Review This review covers the company's strategic growth in the 'Biotech 3.0 Era,' highlighting breakthroughs in core drug pipelines SM03 and SM17, financing, and strategic partnerships - The biopharmaceutical industry is undergoing the third revolution of the 'Biotech 3.0 Era,' characterized by innovation, multidisciplinary integration, and intelligent precision across the value chain[8] - During the reporting period, both core drug pipelines, Suciraslimab (SM03) and SM17, achieved breakthrough progress[9] - The company raised approximately HKD 124 million through share subscriptions, primarily for SM17 clinical advancement and new drug candidate R&D, and completed a new round of financing of approximately HKD 369.5 million in August[16] - The company signed a comprehensive strategic cooperation agreement with Sun Yat-sen University Hong Kong Advanced Research Institute (SYSU-IAS) to accelerate innovative drug development and explore AI for drug target identification[17] Core Drug Pipeline Progress This section details the latest clinical breakthroughs for core drugs Suciraslimab (SM03) and SM17, including strategic indication adjustments and efficacy data - Suciraslimab (SM03) achieved breakthrough preclinical in vivo results in treating Systemic Lupus Erythematosus (SLE), potentially addressing unmet needs regarding long-term safety risks and lack of organ protection in SLE treatment[9][11] - The company strategically and voluntarily withdrew the Biologics License Application (BLA) for Suciraslimab in Rheumatoid Arthritis (RA) and will fully accelerate its clinical development for SLE treatment[12] - Suciraslimab also shows potential in Alzheimer's disease, aiming to be the world's first effective and safe immunotherapeutic for Alzheimer's[13] - SM17 achieved breakthrough top-line results in its Phase 1b proof-of-concept study for moderate-to-severe Atopic Dermatitis (AD): 91.7% of high-dose patients achieved itch relief, 75% achieved skin lesion recovery, and 41.7% achieved complete or almost complete clearance of AD symptoms[14] - These SM17 trial results confirm its triple advantages in AD treatment: rapid itch relief, strong skin lesion recovery, and high safety[15] Other Pipeline Drugs This section introduces other pipeline drugs, including anti-CGC antibodies and bispecific antibodies, showing potential in autoimmune diseases and osteoporosis, with preclinical preparations underway - Anti-CGC antibody is a company-developed humanized anti-γc antibody, a potential therapeutic for alopecia areata, vitiligo, and other autoimmune diseases[16] - The bispecific antibody product targets RANKL and sclerostin, aiming to treat osteoporosis[16] - The company is advancing preclinical preparations for both products, with IND submissions expected in 2026[16] Outlook This section forecasts the recovery and growth opportunities in China's innovative drug market, emphasizing the company's commitment to innovation as a core competency for commercializing existing pipelines and developing new drugs - In the first half of 2025, China's innovative drug outbound licensing transactions totaled USD 66 billion, an increase of approximately 27.2% compared to the full year 2024 total[18] - The National Medical Products Administration (NMPA) compressed innovative drug clinical trial approval time to 30 days, and the National Healthcare Security Administration's "16 Articles for Innovative Drugs" supports payment expansion, promoting the recovery of China's innovative drug market[18] - The company will continue to prioritize innovation as its core competency, driving the commercialization of existing drug pipelines and new drug R&D, believing Suciraslimab and SM17 will further validate their best-in-class characteristics[18] Management Discussion and Analysis Overview As Hong Kong's first listed biopharmaceutical company, the company focuses on R&D, manufacturing, and commercialization of first-in-class monoclonal antibody biologics for immune diseases, aiming to be a global leader by integrating Hong Kong R&D with China's manufacturing capabilities - The company is the first Hong Kong-based biopharmaceutical listed company, primarily developing first-in-class monoclonal antibody-based biologics for immune diseases[21] - Flagship product Suciraslimab (SM03), a potential global first-in-class anti-CD22 monoclonal antibody, achieved breakthrough preclinical results in SLE treatment and has strategically withdrawn its BLA for RA indication to fully accelerate SLE clinical development[22][23] - Key product SM17, a global first-in-class humanized anti-IL-25 receptor monoclonal antibody, achieved positive top-line results in its Phase 1b study for moderate-to-severe AD, demonstrating superior itch relief and skin clearance compared to existing therapies[24] - SN1011, a third-generation reversible covalent BTK inhibitor, has received 4 IND approvals from the NMPA and is being co-developed with Everest Medicines for renal disease indications, showing positive preliminary results[26] Business Review This section reviews the company's clinical project progress during the reporting period, including specific data and strategic adjustments for major product pipelines, as well as updates on collaborations, manufacturing, intellectual property, and human resources - The Group is primarily engaged in the R&D of pharmaceutical products; operational performance, progress, and future prospects of clinical projects during the review period are disclosed in the Chairman's Statement and this section[27] - Except for disclosures in the "Business Overview" section of the Chairman's Statement and this section, the Group has no immediate plans for significant investments or capital assets[27] Clinical Project Progress This section details the latest progress of the company's major clinical projects, including the potential of Suciraslimab (SM03) in SLE and AD, SM17's breakthroughs in AD treatment, and the development stages of other pipeline drugs such as SN1011, SM06, anti-CGC antibody, bispecific antibody, and SM09 Clinical Project Pipeline Overview | Product Line | Indication | Region | Phase I | Phase II | Phase III | BLA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | SM03 (Suciraslimab) | SLE | China | Planned | Planned | | | | | RA | China | | | Completed | Withdrawn | | | Alzheimer's Disease | | IND Preparation | | | | | SM17 | AD | China | Completed 1b | | | | | | Asthma | USA/China | Completed 1 period | | | | | SN1011 | SLE, Pemphigus, NMOSD, MS | China/USA | Completed 1 period | 1b/2a (pMN) | | | | SM06 | RA, NMOSD, SS | USA/China | IND Study | | | | | Anti-CGC antibody | Vitiligo, Alopecia Areata | Global | Preclinical | | | | | Bispecific antibody | Osteoporosis | Global | Preclinical | | | | | SM09 | NHL, Autoimmune Diseases | China | IND Study | | | | - Suciraslimab (SM03) demonstrates three key competitive advantages in SLE treatment: non-depleting B-cell modulation, dual mechanism with bidirectional regulation, and organ protection, showing significant reduction in anti-dsDNA antibody levels, improved proteinuria, and glomerular immune complex deposition in preclinical studies[31][32][33][35][36][37] - SM17 achieved positive top-line results in its Phase 1b proof-of-concept study for moderate-to-severe AD