三牛国健药业(上海)股份有限公司 审计委员会 2023 年度履职情况报告 根据中国证监会《上市公司治理准则》、《上海证券交易所科创板上市公司自 律监管指引第 1 号 -- 规范运作》、《上海证券交易所科创板股票上市规则》等法 律法规、规范性文件,以及《公司章程》和《公司董事会审计委员会工作制度》的 有关规定，2023年度，三生国健药业（上海）股份有限公司（以下简称"公司"）审 计委员会本着勤勉尽职的原则,积极开展各项工作,认真履行相关职责,现将审计 委员会 2023 年度的履职情况报告如下： 一、审计委员会基本情况 报告期内,审计委员会成员无变化,分别为独立董事金永利先生、独立董事黄 反之先生及非独立董事苏冬梅女士。以上委员任期均与公司本届董事会其他董事相 同,其中主任委员由金永利先生担任。 二、董事会审计委员会会议召开情况 2023年度,公司董事会审计委员会根据《公司法》、《公司章程》、《公司董 事会审计委员会工作制度》等相关规定,积极履行专业委员会职责。报告期内,公 司董事会审计委员会共召开了 5 次会议，全体委员都出席了会议，具体情况如下： | 会议名称 | 召开时间 | 会议议案 | | --- | ...

Revenue and Financial Performance - The company's revenue from autoimmune diseases reached CNY 57,193.24 million, with a year-on-year increase of 7.73%[3] - Revenue from oncology products was CNY 22,598.50 million, showing a significant year-on-year growth of 41.8%[3] - The revenue from anti-rejection products amounted to CNY 4,365.08 million, reflecting a substantial year-on-year increase of 59.38%[3] - The company reported a total revenue of 1,060.10 million yuan for the year 2023[40] - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB, representing a 20% year-over-year growth[46] - The company achieved operating revenue of 1,014.03 million RMB in 2023, representing a year-on-year increase of 22.84%[186] - The company’s operating revenue for 2023 reached CNY 101,403.43 million, an increase of 22.84% compared to CNY 82,549.18 million in 2022[87] - The net profit attributable to shareholders was CNY 29,461.44 million, a significant increase of 497.63% from CNY 4,929.73 million in the previous year[87] - The company reported a net profit attributable to the parent company of 29,461.44 million yuan, a staggering increase of 497.63% compared to the previous year[94] - The company’s cash flow from operating activities improved due to increased sales and reduced operational expenses, while cash flow from financing activities showed a net repayment of short-term loans amounting to 100 million RMB[191] Research and Development (R&D) - The company has several key R&D projects in clinical phases, including a humanized monoclonal antibody for moderate to severe plaque psoriasis, currently in Phase III[6] - The company received approval for the NDA of a recombinant human TNF receptor-antibody fusion protein injection for rheumatoid arthritis and other conditions[6] - The company is advancing multiple projects in clinical trials, including a humanized monoclonal antibody for chronic obstructive pulmonary disease (COPD) which has received FDA clinical approval[6] - The company has a robust pipeline with several products in various stages of clinical trials, indicating a strong focus on innovation and market expansion[6] - The company categorizes R&D expenditures into research and development phases, with specific criteria for capitalization of development costs[8] - The company's R&D investment amounted to 49,772.59 million RMB, representing 30.98% of its operating revenue[10] - The average R&D investment among comparable companies in the same industry is 60,573.30 million RMB[10] - The company has a significant focus on R&D, with a net asset ratio of 6.44% for R&D investment[10] - The company reported a significant increase in R&D investment for project 608, which is currently in Phase III clinical trials[12] - The company has 14 ongoing autoimmune projects, with 4 in Phase III, 6 in Phase II, and 2 in Phase I clinical trials as of the report date[109] - The company has multiple innovative research technology platforms for antibody drug development, focusing on oncology and autoimmune diseases[150] - The company has established a comprehensive antibody drug platform covering discovery, development, registration, clinical trials, production, and commercialization, supported by over 20 years of continuous R&D[161] Market Strategy and Expansion - The major sales model, specialized academic promotion, generated 83,491.00 million RMB, a 19.56% increase compared to the previous year[13] - The company plans to strengthen its core competitiveness in the autoimmune disease sector following the licensing agreements with Shenyang Sansheng[19] - The company aims to expand its CDMO services in 2024, leveraging its production experience to provide high-quality, personalized services to emerging biopharmaceutical companies[25] - The company is focusing on the development of bispecific antibodies, which are expected to become a major trend in the antibody field, enhancing treatment efficacy by targeting multiple signaling pathways[23] - The company is enhancing its marketing strategy by leveraging digital platforms and strengthening its sales team to increase market coverage and product competitiveness[26] - The company is focused on becoming a leader in the autoimmune disease sector by building a differentiated capability through a well-structured R&D pipeline and a mature commercialization system[24] - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by the end of 2024[46] - The company is actively developing new products, with three investigational new drug applications (INDs) submitted in the past year, targeting autoimmune diseases[80] - The company is focusing on developing new indications for existing products and exploring innovative targets and molecules to enhance its competitive edge in the autoimmune sector[96] Corporate Governance and Compliance - The company strictly adheres to corporate governance regulations, ensuring compliance with laws and enhancing operational standards[29] - The board of directors actively participates in meetings and has established four specialized committees to support decision-making[29] - The company maintains a robust information disclosure system, ensuring timely and accurate communication with shareholders[29] - There are no significant differences between the company's governance practices and regulatory requirements[30] - The company has not encountered issues regarding independence from its controlling shareholder[30] - The company has implemented measures to ensure compliance with legal and regulatory standards in its operations[29] - The company has received a standard unqualified audit report from Ernst & Young Hua Ming[63] - The board of directors has confirmed the authenticity and completeness of the annual report, ensuring no significant omissions or misleading statements[61] Challenges and Risks - The company acknowledges significant risks in innovative drug development, including long R&D cycles, high investment, and low success rates, which could adversely affect future product launches and market competitiveness[62] - Increased R&D expenditures are anticipated as the company deepens its project pipeline, which may lead to losses if R&D costs exceed profits from commercialized products[62] - The company faces risks related to market competition for its pipeline products, which may impact growth and profitability if not effectively managed[62] - The company anticipates challenges in 2024 due to significant price reductions from participation in the Guangdong Alliance procurement, which may impact Yisaipu's sales revenue[96] - The company faces risks from intensified market competition and potential price reductions due to centralized procurement policies[178] - The company recognizes the risks associated with innovation drug development and is establishing effective management and decision-making systems to mitigate these risks[176] Product Development and Innovation - The company is committed to building a competitive pipeline in the autoimmune disease sector through innovative new targets and expanding existing product indications[25] - The company is focused on strategic development and operational management under the leadership of Lou Jing since 2012[39] - The company is committed to continuous product development and innovation, laying a foundation for future product launches[135] - The company is exploring new targets in biological research and drug development to mitigate technology iteration risks[181] - The company is closely monitoring changes in pharmaceutical policies to adapt its business strategies accordingly[182] Financial Management and Investment - The company’s investment in bank wealth management products reached 60,387.04 million RMB at the end of the period[17] - The company plans to distribute a cash dividend of RMB 0.50 per 10 shares, totaling approximately RMB 30.84 million, which represents 10.47% of the net profit attributable to ordinary shareholders[64] - The total share capital as of December 31, 2023, is 616,785,793 shares, which will be used to calculate the dividend distribution[64] - The company has a commitment to maintaining transparency and accountability in its financial reporting and governance practices[40] - The company has a professional management team with an average of over 20 years of experience in the pharmaceutical industry, enhancing its strategic planning and operational management[165] Partnerships and Collaborations - The company has established partnerships with two major healthcare providers to enhance distribution channels[46] - The company has established partnerships with three leading research institutions to accelerate the development of new therapies[80] - The company generated revenue of 97.4 million from the exclusive licensing agreement with Shenyang Sansheng for its oncology projects in 2023[102] - The company has entered into exclusive licensing agreements for several oncology projects, enhancing its focus on autoimmune disease and inflammation drug development[19] Market Trends and Projections - The global autoimmune market is projected to grow from $132.3 billion in 2022 to $147.3 billion by 2025, with a CAGR of 3.6%, and is expected to reach $176.7 billion by 2030, with biologics accounting for 82.1% of the market share[137] - The Chinese autoimmune and inflammation market is expected to reach $6.1 billion by 2025, with a CAGR of 27.4% from 2022 to 2025, and is projected to exceed $19.9 billion by 2030[140] - The market share of biologics in China is anticipated to increase from 41.9% in 2022 to 69.3% by 2030, with the market size growing from $1.2 billion to $13.8 billion during the same period, reflecting a CAGR of 38.9%[140] - The increasing prevalence of autoimmune diseases and advancements in diagnostic technologies are expected to lead to higher diagnosis rates and treatment demand[137] - The biopharmaceutical industry is characterized by high investment, high technology, and high risk, requiring significant funding and talent for drug development, particularly in the complex field of biologics[143]

关于三生国健药业（上海）股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 目 录 我们审计了三生国健药业（上海）股份有限公司的财务报表，包括2023年12月31 日的合并及公司资产负债表，2023年度的合并及公司利润表、股东权益变动表和现金 流量表以及相关财务报表附注，并于2024年3月20日出具了编号为安永华明（2024）审 字第70072706_B01的无保留意见审计报告。 按照《上市公司监管指引第8号——上市公司资金往来、对外担保的监管要求》的 要求，三生国健药业（上海）股份有限公司编制了后附的2023年度非经营性资金占用 及其他关联资金往来情况汇总表（以下简称"汇总表"）。 如实编制和对外披露汇总表，并确保其真实性、合法性、完整性是三生国健药业 （上海）股份有限公司的责任。我们对汇总表所载资料与我们审计三生国健药业（上 海）股份有限公司2023年度财务报表时所复核的会计资料和经审计的财务报表的相关 内容进行了核对，在所有重大方面没有发现不一致之处。除了对三生国健药业（上海） 股份有限公司2023年度财务报表出具审计报告而执行的审计程序外，我们并未对汇总 表所载资料执行额外的审 ...

三生国健药业（上海）股份有限公司 募集资金存放与实际使用情况鉴证报告 2023年度 三生国健药业（上海）股份有限公司 目 录 | | | 页 次 | | --- | --- | --- | | 一、 | 募集资金存放与实际使用情况鉴证报告 | 1 - 2 | | 二、 | 三生国健药业（上海）股份有限公司 | | | | 2023年度募集资金存放与实际使用情况的专项报告 | 3 - 11 | 募集资金存放与实际使用情况鉴证报告 安永华明（2024）专字第70072706_B02号 三生国健药业（上海）股份有限公司 三生国健药业（上海）股份有限公司董事会： 我们接受委托，对后附的三生国健药业（上海）股份有限公司募集资金存放与实际使 用情况的专项报告（"募集资金专项报告"）进行了鉴证。按照《上市公司监管指引第2号 ——上市公司募集资金管理和使用的监管要求》、《上海证券交易所科创板上市公司自律 监管指引第1号——规范运作》及相关格式指南编制募集资金专项报告，并保证其内容真 实、准确、完整，不存在虚假记载、误导性陈述或重大遗漏是三生国健药业（上海）股份 有限公司董事会的责任。我们的责任是在执行鉴证工作的基础上对募集资 ...

2 | | 社区与公益… | | --- | --- | | 8 | 对标索引. | | | 上海市证券交易所科创板上市公司自律监管指引第 2 号——自愿信息披露》 | | | （上证发〔2022〕14 号） . | | | 上海证券交易所《上海证券交易所科创板股票上市规则（2023年8月修订)》 | | | 对标索引表……………………………………………………………………………………………………………………………………78 | | 9 | 报告编制说明. | | | 编制依据 | | | 报告范围 | | | 数据说明 . | | | 可靠性保证. | | | 联系我们 | | | | | 1. 走进三生国健. | | --- | | 1.1 公司概况 | | 1.2 ESG 管理 . | | ESG 管理架构 . | | ESG 管理策略 . | | 利益相关方沟通 . | | 实质性议题分析 . | | 2 持续提升公司治理水平 . | | 2.1 | | 公司治理架构. | | 内部控制 . | | 投资者权益保护 | | 2.2 合规经营 | | 合规管理体系建设… | | 合规文化建设. | | 2 ...

证券代码：688336 证券简称：三生国健 公告编号：2024-010 三生国健药业（上海）股份有限公司 关于续聘公司 2024 年度审计机构的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 一、拟聘任会计师事务所的基本情况 （一）机构信息 1、基本信息 安永华明会计师事务所（特殊普通合伙）（以下简称"安永华明"）， 于 1992 年 9 月成立，2012 年 8 月完成本土化转制，从一家中外合作 的有限责任制事务所转制为特殊普通合伙制事务所。安永华明总部设 在北京，注册地址为北京市东城区东长安街 1 号东方广场安永大楼 17 层 01-12 室。截至 2023 年末拥有合伙人 245 人，首席合伙人为毛 鞍宁先生。安永华明一直以来注重人才培养，截至 2023 年末拥有执 业注册会计师近 1,800 人，其中拥有证券相关业务服务经验的执业注 册会计师超过 1,500 人, 注册会计师中签署过证券服务业务审计报 1 拟聘任的会计师事务所名称：安永华明会计师事务所（特殊普 通合伙）。 本事项尚需提交股东大 ...

三生国健药业（上海）股份有限公司 2024年，公司将积极采取措施，开展"提质增效重回报"专项 行动，提高公司经营质量，增强投资者回报，提升投资者的获得感， 实现管理层与股东利益的共担共享。 一、聚焦自身免疫性疾病与炎症领域，巩固提升公司核心竞争 力 三生国健是中国首批专注于创新型抗体药物研究并持续积极创 新，拥有研、产、销一体化成熟平台，专注于单抗、双抗、多抗及 多功能重组蛋白等新技术研究。公司拥有超过18年大规模抗体产业 化和质量控制经验，并多维度布局CDMO业务，巩固和增强创新型治 疗药物企业的领导地位。 公司2023年度实现营业收入101,403.43万元，较上年同期同比 增加22.84%；归属于母公司所有者的净利润为29,461.44万元，较上 年同期同比增加497.63%；归属于母公司所有者的扣除非经常性损益 的净利润为21,358.73万元。 推动公司高质量平衡发展 展望2024年，高质量平衡发展是生物医药行业实现跨越式发展 的关键。 全力推动核心产品的临床进度以实现快速上市。2024年度将有 多个核心项目取得重要临床进展：608项目预计将在2024年底完成银 屑病适应症的NDA申报；611项目成 ...

三生国健药业(上海)股份有限公司 2023年度独立董事述职报告 任期内,作为三生国健药业(上海)股份有限公司(以下简 称"公司"）的独立董事,本人严格遵照《公司法》《证券法》 《上市公司治理准则》《上市公司独立董事管理办法》《上海证 券交易所科创板股票上市规则》等相关法律法规和规章制度的规 定及《公司章程》、公司《独立董事工作制度》的要求,本着客 观、公正、独立的原则,勤勉尽责,审慎行使独立董事权利,主 动地了解公司的经营和发展情况,积极出席董事会和股东大会, 参与公司的重大决策,对公司董事会审议的重大事项充分发挥自 身的专业优势,发表独立客观的意见,切实维护了公司的整体利 益和全体股东的合法权益,履行了诚信、勤勉的职责和义务。现 将本人2023年度履行独立董事职责情况汇报如下： 一、 独立董事的基本情况 (一)个人工作履历、专业背景以及兼职情况 黄反之,1967年6月出生,中国国籍,无永久境外居留权, 研究生学历,曾于机械电子工业部从事行业管理,担任过深圳康 迪软件有限公司财务部经理、中国电子工业深圳总公司财务部经 理、飞利浦桑达消费通信有限公司财务部经理、沃尔玛中国有限 公司财务总监、中国南山开发(集团） ...

证券代码：688336 证券简称：三生国健 公告编号：2023-007 三生国健药业（上海）股份有限公司 第四届监事会第十六次会议决议公告 本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 经与会监事认真审议，并以投票表决的方式审议通过了如下决 议： 一、 监事会会议召开情况 三生国健药业（上海）股份有限公司（以下简称"公司"）第四 届监事会第十六次会议通知于 2024 年 3 月 9 日以电话、电子邮件、 专人送达等方式发出。会议于 2024 年 3 月 20 日以通讯方式召开。会 议由监事会主席曹虹女士主持，会议应到监事 3 名，实到监事 3 名。 本次会议的召集与召开程序、出席会议人员资格及议事和表决程序符 合《中华人民共和国公司法》和《三生国健药业（上海）股份有限公 司章程》的有关规定。 二、监事会会议审议情况 1 （四）审议通过《关于公司<2023 年年度利润分配方案>的议案》 经安永华明会计师事务所（特殊普通合伙）审计，2023 年度公 司实现归属于上市公司股东的净利润为人民币 29,461.44 万元，截至 2 ...

经深入核查独立董事金永利、张薇、黄反之的任职经历及个人签署的相关 自查文件，董事会确认各位独立董事在报告期内未在公司担任除独立董事以外 的任何职务，亦未在公司的主要股东单位中担任任何职务。独立董事与公司及 其主要股东之间不存在任何形式的利益冲突、关联关系或其他可能对其独立客 观判断产生影响的情况。公司独立董事在2023年度始终保持高度的独立性，其 履职行为符合《上市公司独立董事管理办法》《上市公司治理准则》以及《公 司章程》中关于独立董事独立性的严格规定和要求，有效地履行了独立董事的 职责，为公司决策提供了公正、独立的专业意见。 三生国健药业（上海）股份有限公司 董事会 三生国健药业（上海）股份有限公司 董事会关于独立董事独立性情况的专项意见 一、独立董事独立性自查情况 三生国健药业（上海）股份有限公司（以下简称"公司"）现有独立董事3 人，分别为金永利、张薇、黄反之。根据《上市公司独立董事管理办法》第六 条的规定，公司独立董事对自身的独立性情况进行了自查，并将自查情况提交 了董事会。自查结果显示，公司独立董事均符合《上市公司独立董事管理办法》 第六条的独立性要求，不存在直接或者间接利害关系，或者其他可能影响 ...