Financial Performance - The company reported a pre-tax loss of RMB 243,111,000 for the fiscal year ending December 31, 2023, a decrease of 14.5% compared to RMB 284,158,000 in 2022[5]. - The total equity of the company decreased to RMB 192,911,000 in 2024 from RMB 295,583,000 in 2023, reflecting a decline of 34.7%[5]. - Other income and gains totaled approximately RMB 7.6 million, a decrease of about RMB 3.1 million compared to the previous year, primarily due to a reduction in government subsidies of approximately RMB 2.4 million[79]. - Research and development costs decreased to approximately RMB 94.8 million in 2024 from RMB 135.4 million in 2023, mainly due to a reduction in laboratory supplies and testing costs by approximately RMB 33.2 million[81]. - Administrative expenses totaled approximately RMB 67.7 million in 2024, down from RMB 97.6 million in 2023, primarily due to a decrease in share-based payments of approximately RMB 13.0 million[82]. - The total available funds, including cash and cash equivalents, pledged and restricted deposits, and structured deposits, decreased to RMB 141.4 million in 2024 from RMB 233.1 million in 2023, a net decrease of approximately RMB 91.7 million[86]. - The net cash used in operating activities was RMB (130.8) million in 2024, compared to RMB (133.8) million in 2023[88]. - As of December 31, 2024, the outstanding bank borrowings amounted to RMB 419.3 million, an increase from RMB 391.4 million in 2023[90]. - The actual interest rates on bank borrowings ranged from 3.15% to 3.90% in 2024, compared to 3.30% to 4.05% in 2023[90]. - The company reported a net current liability of RMB 18,161,000 and a net loss of RMB 185,141,000 for the year ending December 31, 2024[198]. Research and Development - Research and development costs for the fiscal year 2023 were RMB 135,409,000, down 25% from RMB 180,368,000 in 2022[5]. - The flagship product, Suciraslimab, has completed two major regulatory inspections and is awaiting final approval from the National Medical Products Administration for the treatment of rheumatoid arthritis[9]. - The company is actively exploring additional therapeutic applications for Suciraslimab, including its potential use in treating Alzheimer's disease[9]. - The development of SM17, a humanized monoclonal antibody targeting IL-25, is progressing significantly, with potential applications in atopic dermatitis, asthma, and other immune diseases[10]. - The company has added two new candidate drugs to its pipeline, targeting vitiligo and osteoporosis, respectively[11]. - The company aims to achieve three interrelated milestones by 2025: obtaining regulatory approval for Suciraslimab, strategic licensing or collaboration for SM17, and expanding its global footprint[12]. - SM17 demonstrated good safety and tolerability in preclinical and Phase 1 clinical trials, outperforming JAK1 inhibitors[13]. - The Phase 1b proof-of-concept study for SM17 in patients with atopic dermatitis (AD) included 32 moderate to severe patients, with the last patient visit completed on March 24, 2025[13]. - The flagship product, Suciraslimab (SM03), achieved primary endpoints in a Phase 3 clinical study for rheumatoid arthritis (RA) in China, with the Biologics License Application (BLA) accepted in September 2023[22]. - The company is actively exploring partnerships with major pharmaceutical companies to advance the development of SM17 based on strong Phase 1 data obtained in the US and China[13]. - The Phase 1 clinical trial results for SM17 were published in the journal "Frontiers in Immunology," demonstrating excellent safety, tolerability, and pharmacokinetic properties[13]. - The extended Phase III trial for Suciraslimab is expected to complete in December 2024, with results anticipated in Q3 2025[34]. - Suciraslimab's long-term efficacy data indicates sustained response rates over time, suggesting advantages over traditional biologics[34]. - SM17's preclinical studies showed efficacy comparable to JAK1 inhibitors in treating atopic dermatitis in mouse models[39]. - The company plans to advance clinical development of Suciraslimab for additional indications, including SLE and Alzheimer's-related MCI, post-commercialization[35]. - The Phase III trial for Suciraslimab demonstrated effective reduction in disease activity for RA patients[34]. - SM17's mechanism targets IL-25, potentially benefiting patients with allergic and autoimmune diseases[36]. - The IND application for asthma was submitted in May 2023 and approved on August 11, 2023, while the IND application for AD was submitted in June 2023 and approved on September 8, 2023[40]. - A bridging Phase 1a clinical trial in China is expected to complete in May 2024, assessing the safety, tolerability, and PK characteristics of SM17, which showed good tolerability and safety[40]. - The Phase 1b clinical trial for SM17 in moderate to severe AD patients commenced with 32 patients enrolled, with the last patient visit scheduled for March 24, 2025[40]. - SN1011, a third-generation reversible covalent BTK inhibitor, has shown high target selectivity and durable controllable efficacy for potential long-term treatment of SLE, pemphigus, MS, and NMOSD[42]. - The company has established a pipeline of monoclonal antibodies and new chemical entities (NCEs) to address unmet medical needs in immune diseases[21]. - The company is optimizing the CMC for SM06, a second-generation anti-CD22 antibody, which may have stronger immunomodulatory effects[44]. - The company is conducting CMC optimization and toxicology studies for an internally developed anti-γc antibody, which shows potential for treating vitiligo and other autoimmune diseases[46]. - The company has established a preclinical research platform focused on autoimmune diseases, with ongoing clinical projects generating pharmacological data for products like SM06, which is currently in the IND application stage[64]. - The company is optimizing the production and preclinical research of SM09, with plans to apply for clinical trials after completing preclinical studies[68]. Corporate Governance and Management - The management team includes experienced professionals with extensive backgrounds in the pharmaceutical industry, contributing to strategic direction and operational management[104]. - The company is focused on strategic development and governance, with a strong emphasis on independent judgment from its board members[114]. - The board includes members with extensive backgrounds in investment, research, and strategic management within the pharmaceutical sector[112]. - The company has adopted the corporate governance code and has complied with all applicable provisions during the reporting period, except for the separation of roles between the chairman and CEO[134][148]. - The company promotes a corporate culture of "ELITES," focusing on excellence, learning, innovation, talent, efficiency, and collaboration[135][136]. - The company is committed to high standards of corporate governance to protect shareholder interests and enhance corporate value[134]. - The company has a strong management team with extensive research and business management experience, leading to stable progress in drug development[137]. - The company has appointed a new company secretary effective March 31, 2023, enhancing its corporate governance structure[131]. - The board consists of ten members, including two executive directors, four non-executive directors, and four independent non-executive directors[143]. - The board believes that Dr. Liang, as the founder and CEO, has a comprehensive understanding of the company's business, supported by Mr. Wang's role as Executive Director and President (China Region) since his appointment[150]. - The board has maintained compliance with listing rules, ensuring at least three independent non-executive directors, constituting one-third of the board, with one possessing appropriate professional qualifications in accounting or related financial management[151]. - All independent non-executive directors have confirmed their independence in writing according to listing rules, ensuring effective governance and oversight[151]. - The company has established a training program for all directors, covering topics related to their responsibilities under listing rules and relevant legal obligations[158]. - The board held regular meetings throughout the year, with a minimum of four meetings planned, approximately once per quarter, to ensure effective governance[160]. - The company has a high proportion of independent directors, with two executive directors and four independent non-executive directors, ensuring a balanced decision-making process[150]. - The company has implemented a director and officer liability insurance policy, which is reviewed annually to protect against potential legal actions[155]. - The board is responsible for leading and monitoring the company, ensuring good internal controls and risk management systems are in place[154]. - The company has established clear written terms of reference for its three committees: audit, remuneration, and nomination[163]. - The audit committee is tasked with monitoring the effectiveness of risk management and internal control systems[165]. - The remuneration committee reviewed the remuneration policies for all directors and senior management, assessing performance and making recommendations for individual remuneration[172]. - The nomination committee is responsible for reviewing the composition of the board and making recommendations for the appointment of directors[177]. - The board has adopted a diversity policy, recognizing that board diversity is crucial for achieving strategic goals and sustainable development[182]. - The gender ratio at the board level is currently 1:9 (female to male), while the employee level ratio is 45:55[185]. - The board is responsible for reviewing the effectiveness of the risk management and internal control systems, which aim to manage risks associated with achieving business objectives[187]. - An independent consultant was hired to analyze and review the adequacy and effectiveness of the risk management and internal control systems during the fiscal year[188]. - The audit committee reviews the risk management policies to ensure alignment with business strategies and monitors the management's handling of significant risks[193]. - The CFO is responsible for formulating and updating risk management policies and ensuring the implementation of risk management measures across departments[193]. Market and Industry Insights - 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 3.1%[70]. - The Chinese rheumatoid arthritis (RA) treatment market is expected to reach RMB 32.8 billion by 2024 and RMB 83.3 billion by 2030, with a CAGR of 16.8%[70]. - The biopharmaceutical market share for biologics in the Chinese RA treatment market is projected to increase from 43.4% in 2024 to 59.8% by 2030[70]. - The global asthma patient population is expected to reach approximately 860 million by 2030, with a significant increase in patients in China[72]. - The company believes that SM17, targeting the Th2 inflammatory cytokine pathway, will provide a safe and effective treatment option for atopic dermatitis (AD) and asthma[71][72]. Production and Facilities - The Suzhou production facility is expected to pass completion acceptance in early 2025, following the completion of construction by the end of 2024[17]. - The clinical site inspections and GMP checks for the Haikou production base were completed in January 2024, which are necessary for the BLA approval process[22]. - The production facility in Haikou spans approximately 19,163 square meters with a capacity of 1,200 liters, and completed GMP inspection in January 2024[52]. - The second production facility in Suzhou, covering 43,158 square meters, is expected to complete construction by the end of 2024 and pass acceptance inspection in early 2025[53]. - The company has acquired a 43,158 square meter land in Suzhou, China, for a new production facility, expected to be completed by the end of 2024[68]. Intellectual Property - The company holds 91 invention patents as of December 31, 2024, compared to 35 patents as of December 31, 2023, indicating significant growth in intellectual property[56]. - As of December 31, 2024, the company has six pending patent applications in the U.S., seven in China, and six in the EU[54].
中国抗体-B(03681) - 2024 - 年度财报