香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示 概 不 會 就 本 公 告 全 部 或 任 何 部 分 內 容 而 產 生 或 因 倚 賴 該 等 內 容 而 引 致 的 任 何 損 失 承 擔 任 何 責 任。 SinoMab BioScience Limited 中國抗體製藥有限公司 （於香港註冊成立的有限公司） （股份代號：3681） 截 至 二 零 二 四 年 六 月 三 十 日 止 六 個 月 中 期 業 績 公 告 及 更 改 所 得 款 項 用 途 中 國 抗 體 製 藥 有 限 公 司（「本 公 司」，連 同 其 附 屬 公 司 統 稱「本 集 團」）董 事（「董 事」）會（「董 事 會」）謹 此 公 佈 本 集 團 截 至 二 零 二 四 年 六 月 三 十 日 止 六 個 月（「報 告 期」）的 未 經 審 核 中 期 簡 明 綜 合 業 績，連 同 二 零 二 三 年 同 期 的 比 較 數 字。 本 集 團 ...

截至二零二三年十二月三十一日止年度,董事會組成變更如下： 董事之履歷資料載於本年報第23至30頁之「董事及管理層」一節。 主席及首席執行官 根據授權協議,本公司已於二零二一年收取初始預付款4百萬美元,並有權收取最多合共183百萬美元的發展和銷售里程 碑付款。本公司保留SN1011 腎病之自身免疫相關領域外的其他適應症的全部免疫權利,並會繼續推進其研發活動。 各獨立非執行董事已與本公司簽署委任書,初步任期為期三年並須根據細則及上市規則接受重新委任、輪值退任及廖選 連任。 委任及重遴董事 董事會應負責領導及監控本公司,並共同負責指導及監督本公司事務。 童事須向本公司披露彼等擔任的其他職務的詳情。 中國抗體製蔡有限公司 2023年年報 √ J Dylan Carlo TINKER先生 每名新委任的董事於其獲委任之初將接受正式全面的就任需知·以確保彼對本公司業務及營運有適當的了解·並完全知 悉董事在上市規則及相關法律規定下的職責及責任。 培訓類型(附註1) 附註： 2. 於二零二三年九月六日辭任 蘇州生產基地 1. 於二零二三年九月六日辭任 董事於截至二零二三年十二月三十一日止年度舉行的董事會會議及股東大會的出席記錄 ...

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].

約為人民幣 40.9 百萬元。 | --- | --- | --- | |-------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------| | | | | | | 於二零二三年四月二十六日,本公司宣佈 Suciraslimab 在 | 知識產權 | | | 中國治療RA的III期臨床研究中達到主要研究終點。根據對 | | | | 開鍵性數據的評估,Suciraslimab可有效降低接受甲氨蝶哈 | 主要藥物(產品)的核心技術 | | | 治療的活動性RA患者的疾病活動度及緩解疾病症狀。已於 | 就SM03 (Suciraslimab)而言,本集團擁有兩項於中國獲授 | | | 二零二三年八月向國家藥監局提交BLA,以便後續獲得 | 及註冊的發明專利(其中一項發明專利亦適用於SM06)及 | | | Suciraslimab商業化的批准(其一般出現在 ...

Clinical Trials and Product Development - The flagship product SM03 (Suciraslimab) achieved its primary endpoint in the Phase III clinical trial for rheumatoid arthritis (RA) in April 2023, with topline data indicating effective reduction in disease activity [16]. - The clinical trial for the main product SM17 (targeting IL-25 receptor humanized monoclonal antibody) in the US has completed patient enrollment, with the study expected to finish by the end of 2023, six months ahead of schedule [11]. - Two IND applications for SM17 targeting asthma and atopic dermatitis (AD) were submitted in May and June 2023, respectively, with the asthma IND approved on August 11, 2023 [11]. - The company plans to initiate a Phase I clinical trial for SM17 in the Chinese population to explore its safety shortly [11]. - Suciraslimab (SM03) has successfully achieved the primary endpoint in a Phase III clinical trial for treating RA, with 530 participants recruited, exceeding the target of 510 [30]. - The company is advancing the clinical research of Suciraslimab for other immune diseases and plans to apply for IND for mild cognitive impairment (MCI) or Alzheimer's disease [30]. - The company is also progressing the development of SM17, targeting asthma and atopic dermatitis, to enhance its product pipeline competitiveness [20]. - The Phase I clinical trial for SM17 is expected to be completed by the end of 2023 [50]. - The company is exploring new mechanisms for treating autoimmune diseases through collaboration with key opinion leaders in the clinical field [104]. - The company is focused on advancing its R&D projects and establishing a commercialization team to enhance its product portfolio [168]. Financial Performance - The loss for the six months ended June 30, 2023, decreased to RMB 134.1 million from RMB 143.8 million for the same period in 2022, primarily due to a reduction in R&D costs related to the completion of Phase III clinical trials for RA by approximately RMB 15.3 million [43]. - Cash used in investing activities during the reporting period was approximately RMB 61.9 million, mainly for capital expenditures to enhance the group's commercialization production capacity at the Suzhou commercial production base [43]. - Cash generated from financing activities was approximately RMB 42.0 million, primarily due to an increase in net bank borrowings [43]. - The company reported a decrease in cash used in operating activities, mainly due to the completion of the Phase III clinical trial for SM03 [43]. - The group reported a net foreign exchange loss of approximately RMB 20.0 million for the six months ended June 30, 2023 [129]. - The total administrative expenses for the six months ended June 30, 2023, were approximately RMB 50.2 million, an increase from RMB 33.8 million in the same period of 2022 [148]. - The company incurred an operating loss before tax of RMB 134,096 million, an improvement from a loss of RMB 143,790 million in the previous year [192]. - The total assets as of June 30, 2023, were RMB 732,548 million, down from RMB 820,957 million at the end of 2022 [196]. - The company’s cash and cash equivalents amounted to RMB 286,463 million as of June 30, 2023, compared to RMB 345,712 million at the end of 2022 [196]. Production and Capacity Expansion - The company is constructing a commercial production base in Suzhou, China, which will have a maximum total production capacity exceeding 36,000 liters, equating to over one million treatments annually [16]. - The production facility in Suzhou is set to have a first-phase capacity of 6,000 liters, expected to be operational by 2024, while the Haikou facility has a capacity of 1,200 liters [19]. - The new Suzhou facility, covering 43,158 square meters, is under construction and will include commercial production facilities, a research center, and a quality control center, with an expected capacity of 6,000 liters by 2024, increasing total capacity to 200,000 treatments per year [63]. - The company is constructing a second production base in Suzhou to support its growth strategy [39]. - The establishment of a production base in Suzhou is expected to cost RMB 87.6 million, aimed at enhancing large-scale production capabilities [174]. Market Strategy and Business Development - The company aims to expand its market reach and explore additional indications for its products [11]. - The company is actively educating existing and potential investors about product and pipeline development through non-deal roadshows [1]. - The company has established a strong internal strategy development platform for pipeline building [3]. - The company aims to maximize value for investors through a self-sustaining model for future development [46]. - The company is actively seeking collaboration opportunities to enhance its sales and business development capabilities, including licensing and partnerships [80]. - The company has established a market team and plans to continue expanding its sales and marketing teams across most provinces in China to support future commercialization of its research drugs [80]. Research and Development Focus - The company has established a product pipeline based on monoclonal antibodies to address unmet medical needs in various immune diseases [49]. - The company is committed to becoming a global leader in innovative therapies for immune and other degenerative diseases, leveraging its R&D capabilities in Hong Kong and production capabilities in China [49]. - The company is focused on independent innovation and expanding its product pipeline to provide effective treatment options for patients globally [47]. - The company is committed to developing a comprehensive treatment approach for autoimmune diseases, enhancing its market share in this sector [98]. - The company is exploring the potential of SM03 (Suciraslimab) for treating MCI and Alzheimer's disease, based on significant expression of CD22 in neuroglial and other nerve cells [125]. Corporate Governance and Compliance - The company has adhered to high standards of corporate governance, ensuring shareholder interests and increasing transparency [188]. - The company has complied with all applicable corporate governance rules, except for the disclosed deviations [188]. - The company plans to utilize the unutilized proceeds according to the stated intended use [185].

Financial Performance - The company reported a net loss per share of approximately RMB 15.0 million as of December 31, 2022[15]. - For the year ended December 31, 2022, the basic and diluted loss per share was RMB 0.29, consistent with the previous year[54]. - Other income and gains for the reporting period totaled approximately RMB 55.1 million, an increase of about RMB 26.3 million compared to the previous year, primarily due to gains from the sale of investments and government subsidies[156]. - The company reported a foreign exchange loss of approximately RMB 61.9 million for the year ended December 31, 2022, compared to a foreign exchange gain of RMB 9.9 million in 2021[160]. - Cash and cash equivalents at the end of the reporting period amounted to RMB 562,983 thousand[161]. - The total employee cost for the year ending December 31, 2023, was approximately RMB 83.2 million, including director salaries but excluding retirement plan contributions[138]. Borrowings and Liabilities - As of December 31, 2022, the company had bank borrowings secured by land use rights valued at approximately RMB 15.0 million[16]. - As of December 31, 2022, the group's outstanding borrowings amounted to RMB 268.8 million, an increase from RMB 198.8 million as of December 31, 2021[193]. - The borrowings are subject to a fixed annual interest rate of 3.30% and a variable interest rate based on the People's Bank of China's lending benchmark rate, ranging from -0.30% to +0.25%[193]. - The company has no contingent liabilities as of December 31, 2022, compared to none in the previous year[18]. Shareholder Communication and Governance - The company has implemented a shareholder communication policy to ensure shareholder concerns are addressed effectively[3]. - The company regularly reviews its shareholder communication policy to ensure its effectiveness[3]. - The board has approved changes to the use of unutilized funds from share subscriptions to enhance financial resource allocation for future development[20]. - The board is responsible for overseeing the company's ESG-related matters, with various departments executing ESG work and reporting to the board[8]. - The company has established clear responsibilities for managing ESG issues, ensuring accountability at the board level[8]. Research and Development - Research and development costs for 2022 amounted to RMB 180,368,000, a decrease from RMB 199,113,000 in 2021[61]. - The company aims to expand its product pipeline and enhance drug development, production, and commercialization capabilities to become a global leader in innovative therapies for immune diseases[68]. - The company has received 4 IND approvals from the National Medical Products Administration for its main product SN1011, which targets SLE, pemphigus, multiple sclerosis (MS), and neuromyelitis optica spectrum disorder (NMOSD)[72]. - The company is currently prioritizing the clinical development of SN1011 for NMOSD and MS, with strategic plans to submit IND applications and conduct global Phase II clinical trials[81]. - The company is conducting IND applications for asthma treatment, with the first human clinical trial successfully initiated in the U.S. and 59 subjects recruited without serious adverse events reported[83]. - The company has established a product pipeline based on monoclonal antibodies to treat various immune diseases and new chemical entities (NCEs)[71]. - The company is focusing on advancing its flagship product SM03 (Suciraslimab) towards commercialization and expanding its existing product pipeline[121]. Product Development and Clinical Trials - The flagship product SMO3 (Suciraslimab) is a potential first-in-class anti-CD22 monoclonal antibody for treating rheumatoid arthritis, with final study results expected in Q2 2023[51]. - The company plans to submit a Biologics License Application (BLA) to the National Medical Products Administration in China in Q3 2023, aiming for commercialization within 10 to 12 months post-submission[51]. - The company has completed the enrollment for a Phase III clinical trial for rheumatoid arthritis in December 2021[77]. - The Phase I clinical trial for another major product, SM17, commenced in June 2022, with 59 participants enrolled by December 31, 2022, and is expected to complete by Q2 2024[97]. - The company aims to initiate clinical studies for Suciraslimab in treating Alzheimer's disease and Sjögren's syndrome, expanding its therapeutic applications beyond rheumatoid arthritis[104]. - The company reported a successful recruitment of 79 participants for the extended Phase III trial of Suciraslimab, with final efficacy and safety results expected in Q2 2023[96][104]. Production and Capacity Expansion - The company has two production bases, with the Suzhou facility expected to have a capacity of 6,000 liters by early 2024, contributing to a total capacity exceeding 36,000 liters across both sites[52]. - The production capacity at the Haikou facility is approximately 1,200 liters, while the Suzhou facility, upon completion, will exceed 36,000 liters, enhancing the company's manufacturing capabilities[92][93]. - The new Suzhou production base is expected to have an initial capacity of 6,000 liters, projected to be operational by early 2024, contributing to a total capacity of 200,000 treatments annually when combined with the existing 1,200 liters capacity in Haikou[134]. - The maximum total capacity of the Suzhou production base will exceed 36,000 liters, enabling the production of over 1,000,000 treatments annually upon completion[134]. Market and Strategic Focus - The company has a strategic focus on expanding its market presence and enhancing product development capabilities[29]. - The Chinese rheumatoid arthritis (RA) treatment market is projected to reach RMB 28 billion by 2023 and RMB 88.3 billion by 2030, indicating significant growth potential[147]. - The global market for autoimmune disease drugs is projected to grow from USD 120.5 billion in 2020 to USD 163.8 billion by 2030, with a CAGR of 6.0%[171]. - The company aims to become a global leader in innovative therapies for immune and other degenerative diseases, leveraging its R&D capabilities in Hong Kong and production capabilities in China[140]. Collaborations and Partnerships - The company is actively exploring innovative drug target identification and has established a long-term collaboration with D2M Biotherapeutics Limited for this purpose[124]. - The company has established international collaborations to further develop its innovative therapies, including the humanization of SM17 through a partnership with LifeArc[107]. - The company is actively seeking collaboration opportunities to enhance its sales and business development capabilities[170]. Intellectual Property - The company has submitted two invention patent applications for Suciraslimab in the United States and one in China, with a total of four pending patent applications in the U.S. and five in China as of December 31, 2022[115]. - The company holds 27 invention patents, including those pending approval, as of December 31, 2022[138].

Clinical Trials and Product Development - The flagship product SM03 (Suciraslimab) completed recruitment of 530 participants for its Phase III clinical trial, exceeding the target of 510 participants, with results expected in Q2 2023[4]. - The main product SN1011 (BTK inhibitor) received four IND approvals from the National Medical Products Administration, including for systemic lupus erythematosus (SLE), multiple sclerosis (MS), and neuromyelitis optica spectrum disorder (NMOSD)[5]. - The company successfully initiated the first-in-human clinical trial for SM17 (anti-IL-17RB) in the U.S., recruiting 59 participants without reporting serious adverse events[5]. - The Phase III clinical trial for rheumatoid arthritis (RA) has completed recruitment, with efficacy and safety results expected in Q2 2023[22]. - The Phase I clinical trial for SN1011 in Australia was conducted in 2019, and the trial in China was completed in 2021, showing good safety and pharmacokinetic characteristics[41]. - The Phase I clinical trial for SM17 successfully dosed the first healthy subject in June 2022, with 59 participants recruited by December 31, 2022, reporting no serious adverse events[51]. - The company plans to initiate clinical studies for Alzheimer's disease and/or SS in China to expand Suciraslimab's therapeutic applications[47]. - The company aims to prioritize the development of SN1011 for NMOSD and MS in its clinical project strategy[41]. Financial Performance and Investments - The net loss for the year ended December 31, 2022, was RMB 284.2 million, a slight decrease of RMB 4.0 million from RMB 288.2 million for the year ended December 31, 2021[14]. - Cash used in operating activities during the reporting period was approximately RMB 300.5 million, primarily due to cash used in operations of RMB 277.3 million[14]. - Cash generated from financing activities was approximately RMB 102.3 million, mainly from net proceeds of RMB 46.1 million from share issuance and net increase of RMB 66.8 million from bank borrowings[14]. - The company reported a decrease in administrative expenses to approximately RMB 82.6 million in 2022 from RMB 133.4 million in 2021, primarily due to a reduction in non-cash share-based payments[150]. - The company reported a net foreign exchange loss of approximately RMB 61.9 million for the year ended December 31, 2022, compared to a net foreign exchange gain of RMB 9.9 million in 2021[114]. - The company reported a net income of 355,117,000 for other income and gains, compared to 28,751,000 in the previous period[200]. Production and Commercialization - The company is constructing a commercial production base in Suzhou, China, with a maximum production capacity exceeding 36,000 liters, equating to over 1 million treatments annually[5]. - The Suzhou production base is under construction with a total floor area of approximately 75,000 square meters, expected to have a first-phase capacity of 6,000 liters by early 2024[17]. - The combined maximum production capacity of the two production bases will exceed 36,000 liters, capable of producing up to one million treatment courses annually[17]. - The company plans to expand its marketing team and improve production facilities in preparation for upcoming commercialization[19]. - The company aims to commercialize its flagship product SM03 (Suciraslimab) and expand its product pipeline to develop new drugs for treating immune diseases[70]. Research and Development - The company achieved significant advancements in clinical trials, pipeline development, and commercialization preparations during the reporting period[4]. - The company is focused on transitioning from a global pharmaceutical R&D enterprise to a biopharmaceutical company with commercialization capabilities and international vision[9]. - The company is committed to independent innovation and expanding its product pipeline to meet unmet medical needs globally[32]. - The company is developing dual-specific antibodies targeting anti-inflammatory cell surface antigens and Aβ protein for the treatment of Alzheimer's disease and other neurological disorders[101]. - The company has developed a platform to identify a series of antibodies with different functions targeting T cells, addressing a significant gap in its immunotherapy product pipeline[118]. Corporate Governance and Strategy - The company has confirmed compliance with corporate governance standards throughout the reporting period[173]. - The board consists of one executive director, five non-executive directors, and four independent non-executive directors, ensuring a balanced accountability structure[195]. - The company believes that the dual role of the chairman and CEO is in the best interest of the group, despite deviations from corporate governance guidelines[195]. - The company aims to maintain high standards of corporate governance to protect shareholder interests and enhance corporate value[193]. Market Outlook and Future Plans - The company anticipates a rebound in global business activities due to the easing of COVID-19 restrictions, which will facilitate the development and commercialization of its products[19]. - The global market for autoimmune disease drugs is projected to grow from $120.5 billion in 2020 to $163.8 billion by 2030, with a CAGR of 6.0%[96]. - The company aims to enhance its innovation capabilities and increase R&D investment to address industry and policy risks, while also expanding production capacity and reducing unit costs[145]. - The company plans to diversify its product portfolio by discovering and developing new drugs that are currently not in its pipeline[142].

Product Development and Clinical Trials - The flagship product SM03 (Suciraslimab) has completed recruitment of 530 participants in a Phase III clinical trial, exceeding the target of 510[4] - Preliminary results for the primary clinical endpoint of the Phase III study are expected in Q3 2022, with final results for safety and efficacy anticipated in Q1 2023[5] - The company plans to submit a New Drug Application (NDA) for Suciraslimab to the National Medical Products Administration in H1 2023, aiming for commercialization in H2 2023[5] - The third-generation reversible covalent Bruton’s tyrosine kinase inhibitor SN1011 has received three IND approvals for treating systemic lupus erythematosus, pemphigus, and multiple sclerosis[6] - The IND application for SN1011 targeting neuromyelitis optica spectrum disorder was submitted in June 2022 and has been accepted[6] - The first-in-class injectable humanized anti-IL-17RB monoclonal antibody SM17 has received FDA approval for its IND application, with the first human trial initiated in June 2022[6] - The flagship product SM03 (Suciraslimab) completed recruitment for its Phase III clinical trial for rheumatoid arthritis (RA) with 530 participants, exceeding the target of 510[15] - The preliminary results for the primary clinical endpoint of the Phase III study are expected in Q3 2022, with final results for safety and efficacy anticipated in Q1 2023[15] - The company plans to submit a New Drug Application (NDA) for Suciraslimab to the National Medical Products Administration (NMPA) in China in H1 2023, aiming for commercialization in H2 2023[15] - The main product SN1011, a third-generation reversible covalent BTK inhibitor, has received three IND approvals for treating systemic lupus erythematosus (SLE), pemphigus, and multiple sclerosis (MS)[16] - The IND application for NMOSD has been submitted and accepted by the Center for Drug Evaluation (CDE) in June 2022, with NMOSD and MS being strategic priorities for SN1011[16] - The product SM17, a first-in-class humanized anti-IL-17RB antibody, has received FDA approval for its IND application and commenced Phase I clinical trials in the US in June 2022[17] - As of July 31, 2022, 14 participants have been enrolled in the Phase I trial for SM17, which is expected to complete by Q3 2023[17] - The company is also developing SM06, a second-generation anti-CD22 antibody, with plans for IND submission in the US by Q2 2023[17] Financial Performance and Funding - The company reported a net loss attributable to ordinary equity holders of RMB 143.8 million for the six months ended June 30, 2022, compared to a loss of RMB 114.4 million for the same period in 2021, reflecting an increase in losses of 25.7%[60] - The net cash used in operating activities for the six months ended June 30, 2022, was RMB 145.6 million, compared to RMB 88.9 million for the same period in 2021, indicating an increase of 63.8%[56] - The company’s cash flow from operating activities showed a negative trend, with a net outflow of RMB (145,587) thousand, indicating challenges in operational efficiency[77] - The company’s cash flow from financing activities turned positive, suggesting improved access to financing options compared to the previous year[77] - The company reported other income and gains totaling approximately RMB 7.9 million, a decrease of about RMB 4.8 million compared to the same period last year, primarily due to a reduction in bank interest income of approximately RMB 4.3 million[50] - Research and development expenses for Suciraslimab amounted to RMB 514 million during the reporting period[31] - The company received an initial payment of $4 million from Everest Medicines for the global rights to SN1011 for kidney disease, with potential milestone payments totaling $183 million[26] - The company is set to receive a maximum grant of HKD 8 million from the Hong Kong Science Park for clinical trials of SN1011 targeting multiple sclerosis[8] Market and Industry Insights - The global market for autoimmune disease drugs is projected to grow from $120.5 billion in 2020 to $163.8 billion by 2030, with a compound annual growth rate (CAGR) of 6.0%[12] - The Chinese autoimmune disease therapy market is expected to grow from $2.9 billion in 2020 to $24.1 billion by 2030, with a CAGR of 27.7% from 2020 to 2024[12] - The market share of China's autoimmune drug market is expected to increase from 28.6% in 2020 to 68.8% by 2030[12] Research and Development Strategy - The company has been developing monoclonal antibody drugs in the autoimmune disease field for 20 years, with a comprehensive layout across different indications[9] - The company has developed an integrated platform covering drug development, clinical trials, and commercial production, enhancing efficiency in product commercialization[10] - The company aims to create better and safer drugs for patients with unmet treatment needs in the autoimmune disease field[9] - The company is focused on developing innovative antibody candidates targeting new pathways, which may enhance treatment efficacy[49] - Future research strategies include a strong emphasis on B-cell therapy platforms and the development of new therapeutic antibodies[49] Corporate Governance and Compliance - The company has adopted a written guideline for employees regarding securities trading to prevent insider trading[130] - The company is committed to high standards of corporate governance to protect shareholder interests and enhance corporate value[131] - The board of directors confirmed compliance with the standard code of conduct for securities trading during the reporting period[130] - The audit committee, consisting of four independent non-executive directors, reviewed the interim report and financial statements[134] - The company adhered to all applicable corporate governance code provisions during the reporting period, except for the separation of the roles of Chairman and CEO[131] Production and Capacity Expansion - The company has two production bases, with a total capacity of 36,000 liters, aiming for the first phase of production to achieve 6,000 liters by 2024[9] - The company is expanding its production facilities to accelerate the R&D process of pipeline products and improve commercialization efficiency[10] - The company is constructing a second production facility in Suzhou, in addition to its existing site in Haikou[27] - The Suzhou production base, currently under construction, will have a total floor area of approximately 75,000 square meters and an initial production capacity of 6,000 liters, expected to be operational by early 2024, increasing total capacity to 200,000 treatment courses annually[29] Shareholder Information - As of June 30, 2022, the company had 1,006,240,400 issued shares, with major shareholders holding significant stakes, including 285,713,036 shares (28.39%) by Ms. Liu and 129,729,200 shares (12.89%) by Dr. Liang[122][124] - The share incentive plan allows for a maximum of 20,124,808 shares to be awarded to any single participant, which is 2% of the issued shares as of the adoption date[120] - Major shareholders include Shanghai Xingze Investment Management Co., Ltd. with 212,889,400 shares (21.16%) and Hainan Haicai Co., Ltd. with 158,882,115 shares (15.79%)[124] - The shareholding structure indicates that Ms. Liu controls several entities holding shares, including Apricot Oversea Holdings Limited and West Biolake Holdings Limited[125][127] Employment and Human Resources - The total number of employees as of June 30, 2022, was 296, with employee costs incurred during the reporting period amounting to approximately RMB 385 million[33] - The total number of R&D personnel increased from 38 to 40 during the reporting period, with 8 holding doctoral degrees[34] - The total remuneration for key management personnel increased to RMB 7,082,000 for the six months ended June 30, 2022, up from RMB 4,486,000 for the same period in 2021, representing a growth of approximately 58.5%[99][100]

Product Development and Clinical Trials - The flagship product Suciraslimab (SM03) completed recruitment for its Phase III clinical trial in China, exceeding the target with 530 participants against an expected 510[6]. - The company plans to submit a New Drug Application (NDA) for SM03 to the National Medical Products Administration in China in the first half of 2023, with commercialization expected in the second half of 2023[6]. - The company is advancing clinical studies for SM03 in treating systemic lupus erythematosus (SLE) and plans to initiate a Phase II trial in the second half of 2022[6]. - The first-in-human clinical trial for the third-generation reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor SN1011 was completed in July 2021, showing good safety and pharmacokinetic profiles[7]. - The company received approval for SN1011's clinical trial applications for SLE and pemphigus, with plans to start a Phase II global trial for multiple sclerosis (MS) in the third quarter of 2022[7]. - The company has submitted an IND application for its innovative asthma treatment product SM17, which targets IL17RB, with plans to initiate the first human clinical trial in Q1 2022[8]. - The company is optimizing the production of its second-generation anti-CD22 antibody SM06, with plans to submit the first IND application in 2022[8]. - The flagship product SM03 (Suciraslimab) will continue to advance towards commercialization, with clinical trials for rheumatoid arthritis and other autoimmune diseases planned[43]. - The company aims to become a global leader in innovative therapies for immune diseases, focusing on expanding its product pipeline and exploring larger potential indications[14]. - Another product, SM06, is a second-generation anti-CD22 antibody, currently in the optimization process for clinical research expected to begin in Q1 2023[21]. Financial Performance and Investments - The R&D expenses for the year amounted to RMB 199,113 thousand, reflecting a significant investment in product development[4]. - The company reported a loss before tax of RMB 288,194 thousand for the year, which is an increase from RMB 122,600 thousand in the previous year[4]. - Total non-current assets increased to RMB 445,970 thousand from RMB 195,169 thousand in the previous year, indicating growth in long-term investments[4]. - Current assets decreased to RMB 595,685 thousand from RMB 934,354 thousand in the previous year, indicating a reduction in liquid assets[4]. - The total equity of the company decreased to RMB 680,226 thousand from RMB 987,011 thousand in the previous year, reflecting challenges in maintaining shareholder value[4]. - Other income and gains totaled approximately RMB 28.8 million, a decrease of about RMB 29.7 million compared to the previous year, primarily due to a reduction in fair value gains on financial assets by approximately RMB 26.9 million[52]. - Research and development costs increased to approximately RMB 199.1 million in 2021 from RMB 103.4 million in 2020, driven by an increase in laboratory supplies and trial costs by approximately RMB 71.8 million[53]. - Administrative expenses rose to approximately RMB 133.4 million in 2021 from RMB 72.0 million in 2020, mainly due to an increase in non-cash share-based payments by approximately RMB 28.0 million[54]. - As of December 31, 2021, cash and cash equivalents totaled RMB 563.0 million, down from RMB 810.4 million a year earlier, primarily due to capital expenditures of approximately RMB 211.3 million[56]. - The company reported a basic and diluted loss per share of RMB 0.29 for the year ended December 31, 2021, compared to RMB 0.12 for the previous year[59]. Corporate Governance and Management - The company has a dividend policy without a predetermined payout ratio, subject to financial conditions and board recommendations[138]. - The board of directors consists of 1 executive director, 6 non-executive directors, and 4 independent non-executive directors, ensuring a high level of independence[96]. - The company has appointed independent non-executive directors in compliance with listing rules, with at least one possessing appropriate professional qualifications or expertise in accounting or related financial management[97]. - The company has established a three-year specific term for non-executive directors, with reappointment subject to shareholder approval at the annual general meeting[98]. - The company has conducted training courses for all directors, covering a wide range of topics related to their duties and responsibilities under listing rules[101]. - The board of directors held regular meetings, with attendance records showing that all executive directors attended 100% of the meetings[108]. - The audit committee conducted two meetings during the year, with all members present, ensuring oversight of financial reporting and internal controls[112]. - The remuneration committee held three meetings, reviewing the compensation policies for all directors and senior management, with full attendance from the members[114]. - The nomination committee is responsible for reviewing the composition of the board and providing recommendations for director appointments[115]. - The company has established clear written terms of reference for all committees, ensuring accountability and governance standards[109]. Research and Development Focus - The company has developed a comprehensive platform for drug development, clinical trials, and commercialization, enhancing its ability to manage product development and accelerate clinical research[12]. - The company has established a strong R&D and production capability in Hong Kong and China, focusing on monoclonal antibody-based biopharmaceuticals[18]. - The company is actively seeking more collaboration opportunities to enrich its pipeline and expand its global business[9]. - The company aims to strengthen its strategic direction and overall operations through its board members' expertise[72]. - The management team includes members with extensive backgrounds in finance, investment, and clinical research, enhancing the company's strategic capabilities[82]. Employee and Workplace Policies - The company has implemented measures to protect employee health during the COVID-19 pandemic, including temperature checks and flexible work arrangements[13]. - The company has a commitment to creating a fair and healthy work environment, providing diverse growth support and employee benefits[192]. - Total number of employees is 303, with 141 male and 162 female[196]. - Employee turnover rate is 18.11%, with male turnover at 20.79% and female turnover at 15.63%[197]. - The company has implemented a dual-track promotion mechanism for management and professional development[200]. - The company has revised its employee benefits system, increasing transportation and communication subsidies, and providing annual health check-ups[199]. - The company has a strict policy against child labor, with no incidents reported in the current year[194]. - The company employs a flexible working hours system to ensure employee health and safety during the pandemic[199]. ESG and Corporate Responsibility - The report covers the ESG performance of China Antibody Pharmaceutical Co., Ltd. for the year 2021, focusing on environmental, social, and governance aspects[141]. - The company emphasizes its commitment to becoming a global leader in innovative therapies for immune and other debilitating diseases, aiming to meet unmet medical needs[146]. - The board of directors is responsible for overseeing ESG-related matters and has established environmental goals linked to business operations[145]. - Key ESG issues identified include labor standards, product responsibility, and anti-corruption, with active engagement from stakeholders such as government, investors, employees, and the community[149][150]. - The company has implemented a governance structure led by the board, involving multiple functional departments to ensure effective ESG management[147][148]. Quality Control and Compliance - The company has established a comprehensive quality management system, ensuring compliance with the Drug Administration Law and GMP standards, with the CEO overseeing overall quality responsibilities[157]. - A full-cycle quality control system is implemented, covering product development, material selection, production, and clinical trials, ensuring safety and efficacy throughout the product lifecycle[159]. - The company has optimized supplier management and material control processes, implementing a three-tier quality check system for raw materials[160]. - Quality control procedures for finished products have been established, with QC testing and QA review before release, utilizing automated packaging lines to minimize human error[163]. - The company has developed a robust pipeline of innovative therapies, focusing on monoclonal antibodies for various immune diseases, enhancing research and development capabilities[155].

SinoMab BioScience Limited 中國抗體製藥有限公司 Interim Report 2021 中期報告 （於香港註冊成立的有限公司） 股份代號：3681 中期報告 2021 目 錄 2 公司資料 3 主席報告書 5 管理層討論與分析 18 獨立審閱報告 19 中期簡明綜合財務報表 19 中期簡明綜合損益表 20 中期簡明綜合全面收益表 21 中期簡明綜合財務狀況表 23 中期簡明綜合權益變動表 25 中期簡明綜合現金流量表 26 中期簡明綜合財務資料附註 39 其他資料 49 釋義 公司資料 （已退任，自二零二一年六月十五日起生效） | --- | --- | |------------------------------------------------------------|-----------------------------------------| | | | | 董事 | 公司秘書 | | 執行董事 | 黃佩彥女士 | | 梁瑞安博士 （主席兼首席執行官） | 授權代表 | | 非執行董事 | 梁瑞安博士 | | 陳海剛博士 | 華劍平先生 | | 董汛先生 | | ...