证券代码：688336 证券简称：三生国健 公告编号：2023-027 三生国健药业（上海）股份有限公司 关于召开 2023 年第二次临时股东大会的通知 本公司董事会及全体董事保证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、 召开会议的基本情况 （一） 股东大会类型和届次 2023 年第二次临时股东大会 （二） 股东大会召集人：董事会 （三） 投票方式：本次股东大会所采用的表决方式是现场投票和网络 投票相结合的方式 （四） 现场会议召开的日期、时间和地点 召开日期时间：2023 年 9 月 28 日 10 点 00 分 召开地点：中国（上海）自由贸易试验区李冰路 399 号公司会议 室 股东大会召开日期：2023年9月28日 本次股东大会采用的网络投票系统：上海证券交易所股东大 会网络投票系统 （七） 涉及公开征集股东投票权 不涉及。 二、 会议审议事项 本次股东大会审议议案及投票股东类型 | | | 投票股东类型 | | --- | --- | --- | | 序号 | 议案名称 | | | | | A 股股东 | （五） ...

证券代码：688336 证券简称：三生国健 公告编号：2023-026 三生国健药业（上海）股份有限公司 关于变更公司部分董事及高级管理人员的公告 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。 一、董事、总经理辞职情况说明 三生国健药业（上海）股份有限公司（以下简称"公司"）董事 会于近日收到公司董事兼总经理肖卫红先生提交的书面辞职报告。肖 卫红先生因个人原因申请辞去公司总经理、第四届董事会非独立董 事、战略委员会委员职务，辞职后将不再担任公司任何职务。 根据《公司法》《上海证券交易所科创板股票上市规则》《公司 章程》等相关规定，肖卫红先生所负责的工作已经平稳交接，其辞职 不会影响公司董事会的正常运行，亦不会影响公司相关工作的正常运 行，不会对公司规范运作和生产经营产生不利影响。辞职报告自送达 董事会之日起生效。肖卫红先生确认，与公司、董事会、监事会之间 无任何意见分歧，亦无任何与辞职有关的事项需提请公司股东注意。 截至 2023 年 6 月 30 日，肖卫红先生持有上海昊颔企业管理咨询 中心（有限合伙）2,174,26 ...

证券代码：688336 证券简称：三生国健 公告编号：2023-025 三生国健药业（上海）股份有限公司 2023 年第一次临时股东大会决议公告 本公司董事会及全体董事保证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： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2023 年 9 月 12 日 （四） 表决方式是否符合《公司法》及公司章程的规定，大会主 持情况等。 本次股东大会由公司董事会召集，董事长 LOU JING 先生主持召 开。本次股东大会采用现场投票和网络投票相结合的方式表决。公司 聘请了国浩律师事务所苗晨、苏成子律师对本次股东大会进行见证。 本次会议的召集、召开和表决均符合《公司法》及《公司章程》等有 关规定，所作决议合法、有效。 （二） 股东大会召开的地点：中国（上海）自由贸易试验区李冰 路 399 号公司会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的 优先股股东及其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 10 | | --- | --- ...

告律師(上海)事務所 ANDALL LAW FIRM (SHANGHAI) 成都 宁波 福州 西安 南京 南宁 济南 香港 巴黎 马德 海市北京西路 968 号嘉地中心 23-25 层 25/F. Garden Square. 968 West Beijing Road. Shanghai 2000 电话/Tel: +86 21 52341668 传真/Fax: +86 21 5234 网址/Website: http://www.grandall.com.c 国浩律师(上海)事务所 关于三生国健药业(上海)股份有限公司 2023 年第一次临时股东大会的 法律意见书 致:三生国健药业(上海)股份有限公司 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民共和国证 券法》(以下简称"《证券法》")和中国证券监督管理委员会《上市公司股东大会 规则》(以下简称"《股东大会规则》"）的规定,国浩律师(上海)事务所接受三 生国健药业(上海)股份有限公司(以下简称"公司")董事会的聘请,指派律师 见证公司于 2023年 9 月 12 日召开的公司 2023 年第一次临时股东大会。本所律师 依据有关法律、法 ...

华泰联合证券有限责任公司 关于三生国健药业（上海）股份有限公司 2023年半年度持续督导跟踪报告 根据《证券法》、《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板股票上市规则》等有关法律、法规的规定，华泰联合证券有限责任公司（以 下简称"华泰联合证券"或"保荐机构"）作为三生国健药业（上海）股份有限 公司（以下简称"三生国健"、"公司"或"发行人"）持续督导的保荐机构，负 责三生国健上市后的持续督导工作，并出具本半年度持续督导跟踪报告。 一、保荐机构和保荐代表人发现的问题及整改情况 二、重大风险事项 公司目前面临的风险因素主要如下： （一）创新药研发面临不确定性以及较大市场竞争的风险 创新药研发具有研发周期长、投入大、风险高、成功率低的特点，从立项到 新药获批上市要经过临床前研究、临床试验、新药注册上市和售后监督等诸多复 杂环节，每一环节都有可能面临失败风险。未来，公司需持续进行创新药研发， 以保证公司不断有新产品推向临床进而推向市场。但公司无法保证可以持续地找 到有商业价值的适应症，公司筛选出的潜在产品有可能因为有效性不足等原因而 没有进一步开发的潜力。若公司无法持续的研发有商业潜力的新产品，可能 ...

证券代码： 688336 证券简称：三生国健 三生国健药业（上海）股份有限公司 2023 年第一次临时股东大会会议资料 二〇二三年九月 1 三生国健药业（上海）股份有限公司 2023 年第一次临时股东大会会议须知 为了维护全体股东的合法权益，确保股东大会的正常秩序和议事 效率，保证大会的顺利进行，根据《中华人民共和国公司法》、《中 华人民共和国证券法》、《上市公司股东大会规则（2022 年修订）》 以及《三生国健药业（上海）股份有限公司章程》（以下简称"《公 司章程》"）、《三生国健药业（上海）股份有限公司股东大会议事 规则》等相关规定，特制定 2023 年第一次临时股东大会会议须知。 一、为保证本次大会的严肃性和正常秩序，切实维护与会股东（或 股东代理人）的合法权益，除出席会议的股东（或股东代理人）、公 司董事、监事、高级管理人员、见证律师及董事会邀请的人员外，公 司有权依法拒绝其他无关人员进入会场。 二、出席会议的股东及股东代理人须在会议召开前半小时到会议 现场办理签到手续，并按规定出示证券账户卡、身份证明文件或营业 执照复印件（加盖公章）、授权委托书等，上述登记材料均需提供复 印件一份，个人登记材料复印 ...

证券代码：688336 证券简称：三生国健 公告编号：2023-024 三生国健药业（上海）股份有限公司 关于参加 2023 年半年度制药及生物制品集体业绩 说明会的公告 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： （http://roadshow.sseinfo.com/） 投资者可于 2023 年 9 月 6 日(星期三) 前通过邮件、电话、传真等 形式将需要了解和关注的问题提前提供给公司。公司将在文字互动环 节对投资者普遍关注的问题进行回答。 三生国健药业（上海）股份有限公司（以下简称"公司"）已于 2023 年 8 月 25 日发布公司 2023 年半年度报告，为便于广大投资者 更全面深入地了解公司 2023 年半年度经营成果、财务状况、发展理 念，公司参与了由上交所主办的 2023 年半年度制药及生物制品集体 业绩说明会，此次活动将采用视频和网络文字互动的方式举行，投资 者可登录上海证券交易所上证路演中心 （http://roadshow.sseinfo.com/）参与线上互动交流。 一、 说 ...

Financial Performance - The company's operating revenue for the first half of 2023 reached ¥477,808,271.19, representing a 40.28% increase compared to ¥340,598,466.82 in the same period last year[27]. - The net profit attributable to shareholders was ¥94,754,571.46, a significant recovery from a loss of ¥7,189,365.95 in the previous year[27]. - The net cash flow from operating activities was ¥161,233,281.22, reflecting a 45.81% increase from ¥110,578,905.71 in the prior year[27]. - The company's total assets decreased by 1.18% to ¥5,038,430,293.35 from ¥5,098,403,734.80 at the end of the previous year[27]. - The net assets attributable to shareholders increased by 2.19% to ¥4,706,545,083.43 from ¥4,605,846,042.52 at the end of the previous year[27]. - The company reported a basic earnings per share (EPS) of 0.15 yuan, compared to a loss of 0.01 yuan in the same period last year, marking a significant turnaround[56]. - The diluted EPS also stood at 0.15 yuan, reflecting the same improvement as the basic EPS[56]. - The weighted average return on net assets increased by 2.20 percentage points to 2.04% from -0.16% year-on-year[56]. - The R&D expenditure as a percentage of operating income decreased by 8.87 percentage points to 34.56% from 43.43% in the previous year[56]. - The company reported a revenue of ¥477,808,271.19 for the first half of 2023, representing a year-on-year increase of 40.28% compared to ¥340,598,466.82 in the same period last year[149]. - The operating costs for the same period were ¥119,129,741.34, which is a 36.38% increase from ¥87,352,646.53 year-on-year[149]. - The company repaid CNY 100 million in short-term loans during the first half of 2023, resulting in a net cash flow from financing activities decrease[176]. - The company's trading financial assets decreased by 49.55% to CNY 749.87 million, primarily due to the redemption of financial products during the reporting period[174]. - The company reported a decrease in short-term borrowings by 66.69% to CNY 50.00 million, reflecting repayment efforts[174]. Revenue Drivers - The increase in operating revenue was primarily driven by higher sales of core products such as Yisai Pu and Saiputing, as well as an increase in CDMO order volume[28]. - The company reported a significant increase in revenue, achieving a total of $X million for the quarter, representing a Y% growth year-over-year[34]. - The company achieved a revenue of CNY 477.81 million in the first half of 2023, representing a 40.28% increase compared to the same period last year[174]. - The increase in revenue was primarily driven by higher sales volumes of Yisai Pu, Saiputing, and Jianipai, as well as an increase in CDMO order volumes compared to the previous year[175]. - The revenue from the product Saiputing increased by 60.46% year-on-year, driven by expanded patient access and successful negotiations for reimbursement[140]. Research and Development - The company plans to continue investing in research and development, which may lead to increased expenses if core product sales do not meet expectations[6]. - The company is investing in R&D, allocating $F million towards the development of new technologies and products[35]. - The company has a total of 12 products in its R&D pipeline, with 19 clinical projects, including 7 collaborative projects[133]. - The company has developed a humanized monoclonal antibody targeting IL-17A ("608") for plaque psoriasis, which has been included in the national list of 48 urgently needed drugs, indicating significant market potential[85]. - The company has achieved important milestones in the first half of 2023, including the submission of IND applications to the FDA and NMPA[89]. - The company has initiated capitalizing expenses related to R&D projects that enter Phase III clinical trials, resulting in significant capitalized expenditures in the first half of 2023[101]. - The company has invested a total of RMB 1.45 billion in its R&D projects, with RMB 77 million invested in the current period[103]. - The company employs 263 R&D personnel, accounting for 24.33% of its total workforce, with an average salary of RMB 11.42 thousand[104]. - The company’s innovative antibody drug platforms cover the entire drug development process, from basic research to clinical trials and new drug registration[106]. Market Position and Strategy - The company faces risks related to the uncertainty of innovative drug development and increased competition in the market[5]. - The company emphasizes the importance of continuous innovation in drug development to maintain market competitiveness[5]. - The company has signed exclusive licensing agreements for several oncology projects, allowing it to focus on autoimmune disease and inflammation drug development[54]. - The company has successfully completed multiple clinical milestones, including the approval of the pre-filled syringe for "Yisai Pu" in March 2023[54]. - The company is focusing on autoimmune diseases and inflammation, enhancing its core competitiveness in this field through strategic transactions[157]. - The company has established a scientific decision-making system to mitigate risks in drug development[158]. - The company is implementing precise sales strategies to enhance product accessibility and market penetration[162]. - The company is actively pursuing new product development and market expansion, with a rich pipeline of innovative drugs[162]. - The company has a robust pipeline with multiple monoclonal antibodies targeting various diseases, including rheumatoid arthritis and asthma[84]. Clinical Development - The company’s clinical pipeline includes a new anti-IL-4Rα monoclonal antibody (611) that has received NMPA approval for chronic rhinosinusitis with nasal polyps[66]. - The anti-IL-17A monoclonal antibody (608) has completed patient enrollment for its Phase III clinical trial for moderate to severe plaque psoriasis[66]. - The company plans to complete the important milestone of the Phase II clinical study for severe eosinophilic asthma in the second half of 2023[71]. - The company has developed another humanized monoclonal antibody targeting IL-4Rα ("611") for treating moderate to severe atopic dermatitis and asthma, showing comparable biological activity to the marketed drug Dupixent[86]. - In the Phase II clinical study for moderate to severe atopic dermatitis, "611" demonstrated significant efficacy over the placebo group, with a trend of higher response rates compared to existing treatments[86]. - The company plans to submit materials for the Phase III clinical study of acute gouty arthritis to the CDE and has received feedback from the CDE[75]. - The Phase II clinical trial for chronic rhinosinusitis with nasal polyps using the IL-4Rα monoclonal antibody (611) completed its first patient enrollment in July 2023[74]. - The company has successfully renewed the national negotiation for Saiputing, enhancing patient accessibility to the drug[64]. Market Trends and Projections - The domestic autoimmune disease drug market is projected to grow from $1.7 billion in 2017 to $3.6 billion in 2022, with a compound annual growth rate (CAGR) of 16%[46]. - The biopharmaceutical market for autoimmune diseases is expected to reach $16.6 billion by 2030, with a CAGR of 36% from 2022 to 2030[46]. - The Chinese anti-HER2 monoclonal antibody market is expected to reach approximately RMB 9.4 billion in 2023, with a compound annual growth rate (CAGR) of about 23.9% from 2018 to 2023, continuing to grow at a CAGR of approximately 5.3% to around RMB 13.6 billion by 2030[94]. - The market for autoimmune disease drugs in China has grown from $1.7 billion in 2017 to $3.6 billion in 2022, with a compound annual growth rate (CAGR) of 16%[93]. - The company’s product Yisaipu holds a 23.7% market share in the TNF-α drug category as of the first half of 2023, despite increasing competition[93]. Operational Efficiency - The company has implemented new strategies aimed at improving operational efficiency, projected to reduce costs by H%[34]. - Management expenses decreased by 22.76%, amounting to a reduction of 10.19 million yuan, due to cost-cutting measures[167]. - The company has established a production quality management process covering the entire product lifecycle, from development to commercialization[123]. - The company has a production capacity of over 40,000 liters for antibody drugs, with fully automated and information-based production lines[123]. - The company aims to enhance its commercialization capabilities and expand hospital coverage, currently reaching over 1,300 hospitals for Saiputing[140].

华泰联合证券有限责任公司 关于三生国健药业（上海）股份有限公司 调整募投项目拟投入募集资金金额、部分募投项目 新增实施内容的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合"、"保荐机构"）作为三生 国健药业（上海）股份有限公司（以下简称"三生国健"、"公司"）首次公开发行 股票并在科创板上市的保荐机构，根据《证券发行上市保荐业务管理办法》、《上 海证券交易所科创板股票上市规则》以及《科创板上市公司持续监管办法（试行）》 等有关规定，对三生国健调整募投项目拟投入募集资金金额、部分募投项目新增 实施内容进行了审慎核查，核查情况及意见如下： 一、变更募投资金投资项目概述 （一）募集资金基本情况 根据中国证券监督管理委员会于 2020 年 6 月 23 日出具的《关于同意三生国 健药业（上海）股份有限公司首次公开发行股票注册的批复》（证监许可 [2020]1217 号），公司获准向社会公开发行人民币普通股（A 股）61,621,142 股， 发行价为每股人民币 28.18 元，募集资金总额为人民币 1,736,483,781.56 元，扣 除承销费以及其他发行费用（含增值税）后，实际募集资金净额计人民币 1, ...

二、对《关于继续使用部分暂时闲置募集资金进行现金管理的议案》的独立意 鬼 三生国健药业(上海)股份有限公司独立董事 关于第四届董事会第十八次会议相关事项的独立意见 根据《中华人民共和国公司法》、《上市公司独立董事规则》、《上海证券交 易所科创板股票上市规则》、《三生国健药业(上海)股份有限公司章程》、《董 事会议事规则》、《独立董事工作制度》等相关法律、法规和规范性文件规定,我 们作为三生国健药业(上海)股份有限公司(下称"公司")独立董事,在仔细阅 读有关材料和充分核查实际情况的基础上,对 2023年8月24日公司第四屆董事会 第十八次会议审议的相关事项发表以下独立意见: 对《关于调整募投项目拟投入募集资金金额、部分募投项目新增实施内 一、 容的议案》的独立意见 经核查,我们一致认为:本次调整募投项目拟投入募集资金金额、部分募投项 目新增实施内容是公司根据当前市场环境、公司业务发展规划及项目实施的实际需 要而做出的审慎决策,有助于提高募集资金使用效率,不存在损害公司及股东利益 的情形,不会对公司的正常生产经营产生重大不利影响。公司本次调整募投项目拟 投入募集资金金额符合中国证监会、上海证券交易所关于募集资金 ...