Financial Performance - The company reported a net loss attributable to ordinary shareholders of RMB 243,111,000 for the year, compared to a loss of RMB 284,158,000 in the previous year[25]. - There was no declaration or payment of dividends for the years ended December 31, 2023, and December 31, 2022[3]. - The company has not made adjustments to the basic loss per share for the year ended December 31, 2023, despite the potential dilution effect of unexercised share options[2]. - Losses for the year decreased by RMB 41.1 million, from RMB 284.2 million in 2022 to RMB 243.1 million in 2023, primarily due to the completion of Phase III clinical trials for SM03[68]. - Cash and cash equivalents totaled RMB 233.1 million as of December 31, 2023, down from RMB 345.7 million a year earlier[68]. - Net cash used in operating activities decreased from RMB 300.5 million in 2022 to RMB 133.8 million in 2023 due to cost-saving measures[68]. - Administrative expenses totaled approximately RMB 97.6 million for the year ended December 31, 2023, compared to RMB 82.6 million in 2022, with the increase mainly attributed to share-based payments rising by approximately RMB 15.2 million[176]. - The net cash flow used in operating activities was RMB (133.8) million for the year ended December 31, 2023, compared to RMB (300.5) million in 2022, indicating an improvement in operational cash flow[179]. - The total cash and cash equivalents at the end of the year were RMB 203.7 million, down from RMB 342.9 million at the beginning of the year, reflecting a net decrease of RMB (148.5) million[179]. - Other income and gains amounted to approximately RMB 10.7 million during the reporting period, a decrease of about RMB 44.4 million compared to the year ended December 31, 2022, mainly due to a prior year gain from the fair value of investments[194]. Share Capital and Financing - The weighted average number of ordinary shares issued during the year was 1,018,115,585 shares, an increase from 991,956,078 shares in the previous year[25]. - The total number of issued ordinary shares as of December 31, 2023, was 1,034,920,400, unchanged from the previous year[8]. - The company's overdraft financing amounted to RMB 907,555,000, up from RMB 750,000,000 in the previous year, with RMB 409,657,000 utilized by the end of the reporting period[27]. - As of the announcement date, 49,878,400 share options were granted under the 2022 share option plan, with 49,778,400 options remaining unexercised[38]. - The company plans to seek approval from the Stock Exchange for the proposed increase in the share option scheme limit, which will not exceed 10% of the total issued shares as of the date of the approval[18]. Research and Development - The company is focused on research, development, production, and commercialization of innovative therapies for immune-related diseases[67]. - The main product SM17 is a first-in-class humanized IgG4-k monoclonal antibody targeting IL-25, with potential applications in treating AD, asthma, and IPF[30]. - The company completed all patient enrollment for Phase I clinical trials of SM17 in the U.S. by September 2023, with plans to initiate Phase Ib studies for AD patients shortly[48]. - Two IND applications for asthma and AD were submitted to the National Medical Products Administration in China in May and June 2023, respectively, and were approved in August and September 2023[48]. - The flagship product SM03 (Suciraslimab) achieved primary study endpoints in the Phase III clinical trial for treating RA in China, demonstrating effective reduction of disease activity in moderate to severe RA patients[56]. - The company submitted a Biologics License Application (BLA) for Suciraslimab to the National Medical Products Administration of China in August 2023, with approval expected within 10 to 12 months post-submission[56]. - The company is developing another major product, SN1011, a third-generation reversible covalent BTK inhibitor, which has received four IND approvals from the National Medical Products Administration of China for treating SLE, pemphigus, MS, and NMOSD[58]. - The clinical trial for Suciraslimab included 530 participants, exceeding the initial target of 510, and the extended trial continues to gather data on long-term efficacy and safety[61]. - The company is focusing on the commercialization of SM03 for rheumatoid arthritis (RA) before considering the advancement of SM03 for other indications such as systemic lupus erythematosus (SLE) and Alzheimer's disease[109]. - The company is currently optimizing the chemistry, manufacturing, and controls (CMC) processes for SM06, a second-generation anti-CD22 antibody[89]. - The company is developing a preclinical research platform to study the mechanisms of autoimmune diseases and explore effective treatment methods[127]. - The internal R&D team is focusing on new mechanisms for treating various autoimmune diseases, including rheumatic diseases and skin diseases[127]. Market and Industry Outlook - The macroeconomic environment is gradually recovering to pre-pandemic levels, presenting growth opportunities for innovative drug companies in 2023[44]. - The company is optimistic about the biotechnology market in 2024, supported by favorable policies in Hong Kong for the pharmaceutical industry[73]. - The global autoimmune disease drug market is projected to grow from $120.5 billion in 2020 to $163.8 billion by 2030, with a CAGR of 6.0%[155]. - The estimated market size for rheumatoid arthritis (RA) treatment in China is expected to reach RMB 28 billion by 2023 and RMB 83.3 billion by 2030[155]. - The Chinese market for atopic dermatitis (AD) drugs was valued at $600 million in 2019 and is expected to grow to $1.5 billion by 2024 and further to $4.3 billion by 2030[134]. - The number of asthma patients globally is projected to reach approximately 86 million by 2030, with a significant increase in China, which is expected to reach 7.81 million patients[135]. Production and Facilities - The Haikou production base is the primary site for product commercialization and has supported multiple product development efforts since its completion[50]. - The Suzhou production base is steadily developing to support future research and commercialization efforts[50]. - The production base in Haikou covers an area of approximately 19,163 square meters with a capacity of 1,200 liters, sufficient for clinical and initial commercialization needs[95]. - The company is constructing a second production base in Suzhou, which will include commercial production facilities, a research center, and a quality control center, covering a total area of approximately 75,000 square meters[96]. - The company completed the GMP inspection of the Haikou production base in January 2024, which is a necessary requirement for BLA approval[95]. Strategic Initiatives - The company aims to explore potential business collaboration opportunities and expand its commercial footprint in the biotechnology market in 2024[73]. - The company aims to solidify its leading position in the immunology field through specialized research on innovative therapies for immune diseases[124]. - The company plans to actively educate existing and potential investors about product and pipeline development through non-deal roadshows[125]. - The company is enhancing its proactive strategy research and will continue to invest in new drug development while adhering to prudent principles[166]. - The company acknowledges the high risks and long development cycles associated with new drug development, which may face various challenges at different stages[142]. Intellectual Property - The company has submitted patent applications for SM18 and SM32 in the United States, along with several PCT patent applications during the reporting period[99]. - The company has received four invention patents registered in China and four in the United States for SM03 (Suciraslimab), which also applies to SM06[97]. - As of December 31, 2023, the company has a total of 35 patents, including pending and granted patents[122].
中国抗体-B(03681) - 2023 - 年度业绩