证券代码：688238 证券简称：和元生物 公告编号：2024-041 和元生物技术（上海）股份有限公司 2024 年第二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 本次股东大会由公司董事会召集，董事长潘讴东先生主持，采用现场表决与 网络投票相结合的方式召开。本次会议的召集、召开及表决方式符合《中华人民 共和国公司法》《上海证券交易所科创板股票上市规则》及《和元生物技术（上 海）股份有限公司章程》（以下简称"《公司章程》"）的相关规定。 （五） 公司董事、监事和董事会秘书的出席情况 1、 公司在任董事 8 人，出席 8 人； 2、 公司在任监事 3 人，出席 3 人； 3、 董事会秘书出席了本次会议；其他高级管理人员及见证律师列席了会议。 一、 会议召开和出席情况 （一） 股东大会召开的时间：2024 年 9 月 19 日 （二） 股东大会召开的地点：上海市浦东新区国际医学园区紫萍路 908 弄 19 号 楼会议室 （三） 出席会议的普通股股东、特别表 ...

冷 中 中国上海市延安东路 222 号外滩中心 40 楼 2000 Tel/电话:(8621) 6249 6040 Fax/传真:(8621) 6248 2266 Website/网址: www.jinmao.com.cn 上海市金茂律师事务所 关于和元生物技术(上海)股份有限公司 2024年第二次临时股东大会之法律意见书 致:和元生物技术(上海)股份有限公司 和元生物技术（上海）股份有限公司（以下简称"公司"）2024 年第二次临时 股东大会（以下简称"本次股东大会"）于 2024 年 9 月 19 日下午在公司会议室召 开。上海市金茂律师事务所(以下简称"本所")经公司聘请并接受公司委托,委 派茅丽婧律师、马也律师(以下简称"本所律师")出席本次股东大会,并根据《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》")、中国证券监督管理委员会公布的《上市公司股东大 会规则》(以下简称"《股东大会规则》")等相关法律、法规和规范性文件以及 《和元生物技术(上海)股份有限公司章程》(以下简称"《公司章程》"),就 本次股东大会的召集、召开程序、出席会议人员资格、 ...

| 保荐机构名称：海通证券股份有限公司 | 被保荐公司简称：和元生物 | | --- | --- | | 保荐代表人姓名：陈恒瑞、张子慧 | 被保荐公司代码：688238 | 重大事项提示 2024 年 1-6 月，公司实现营业收入 11,306.16 万元，同比增长 35.00%，实现 归属于母公司所有者的净利润-11,334.54 万元，实现归属于母公司所有者的扣除 非经常性损益的净利润-11,940.92 万元，较上年同期下降；经营活动产生的现金 流量净额-11,462.98 万元，较上年同期减少；主要由于持续受外部投融资环境影 响，国内细胞和基因治疗行业下游客户融资仍存在不畅，市场订单价格处于较低 水平，同时由于临港产业基地一期投入运行，短期内公司折旧摊销、日常运营成 本费用大幅增加，综合导致营业毛利和净利润下降，经营活动产生净现金流量净 额减少。 细胞和基因治疗是生物医药行业未来的重点发展方向，国家产业政策持续加 大支持，随着行业调整的逐步完成，公司将借助国际领先的大规模临港产业基地， 进一步发挥业务全面性、技术多样化、项目成功经验丰富等竞争优势，在不断拓 展国内外市场、布局新业务领域、降本增效等应 ...

证券代码：688238 证券简称：和元生物 和元生物技术（上海）股份有限公司 投资者关系活动记录表 | --- | --- | --- | |-----------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | 投资者关系活动 \n类别 | 特定对象调研 \n 媒体采访 \n 新闻发布会 \n 现场交流 \n 其他（电话会议等） | 分析师会议 \n 业绩说明会 \n 路演活动 | | | 2024 年 8 月 29 日 : | | | 参与单位名称 | 管、大连道合投资、上海五地私募基金 | 东方证券、海通证券、中金公司、浙商证券、国海证券、华 ...

证券代码：688238 证券简称：和元生物 公告编号：2024-040 和元生物技术（上海）股份有限公司 股东减持计划时间届满暨权益变动达 1%的公告 本公司董事会、全体董事及相关股东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： 大股东持股的基本情况 本次减持计划实施前，和元生物技术（上海）股份有限公司（以下简称"公 司"）股东上海檀英投资合伙企业（有限合伙）（以下简称"上海檀英"）及其 一致行动人上海乾刚投资管理合伙企业（有限合伙）（以下简称"上海乾刚"）、 上海乐永投资合伙企业（有限合伙）（以下简称"上海乐永"），合计持有公司 股份 52,339,300 股，占公司总股本的比例为 8.0841%。其中：上海檀英持有公 司股份 35,087,780 股，占公司总股本的比例为 5.4195%；上海乐永持有公司股 份 16,224,000 股，占公司总股本的比例为 2.5059%；上海乾刚持有公司股份 1,027,520 股，占公司总股本的比例为 0.1587%。 上述股份为公司首次公开发行股票并上市前取得的股份，及公司实施资 ...

股票简称：和元生物 股票代码：688238 2024 年第二次临时股东 大会会议资料 和元生物技术（上海）股份有限公司 OBiO Technology (Shanghai) Corp., Ltd. 2024 年 9 月 和元生物技术（上海）股份有限公司 2024 年第二次临时股东大会会议资料 和元生物技术（上海）股份有限公司 2024 年第二次临时股东大会会议资料目录 | 2024 | 年第二次临时股东大会会议须知 2 | | --- | --- | | 2024 | 年第二次临时股东大会会议议程 4 | | 2024 | 年第二次临时股东大会会议议案 6 | | | 议案一、《关于变更董事的议案》 7 | 1 和元生物技术（上海）股份有限公司 2024 年第二次临时股东大会会议资料 和元生物技术（上海）股份有限公司 2024 年第二次临时股东大会会议须知 为维护广大投资者的合法权益，确保和元生物技术（上海）股份有限公司（以 下简称"公司"或"和元生物"）股东大会的正常秩序和议事效率，保障股东在 本次股东大会期间依法行使权利，根据《中华人民共和国公司法》（以下简称"《公 司法》"）、中国证监会《上市公司股东大 ...

证券代码：688238 证券简称：和元生物 公告编号：2024-034 和元生物技术（上海）股份有限公司 股东减持股份时间过半未减持股份 暨减持进展公告 本公司董事会、全体董事及相关股东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： 大股东持股的基本情况 本次减持计划实施前，和元生物技术（上海）股份有限公司（以下简称"公 司"）股东上海檀英投资合伙企业（有限合伙）（以下简称"上海檀英"）及其一 致行动人上海乾刚投资管理合伙企业（有限合伙）（以下简称"上海乾刚"）、上海 乐永投资合伙企业（有限合伙）（以下简称"上海乐永"），合计持有公司股份 52,339,300 股，占公司总股本的比例为 8.0841%。其中：上海檀英持有公司股份 35,087,780 股，占公司总股本的比例为 5.4195%；上海乐永持有公司股份 16,224,000 股，占公司总股本的比例为 2.5059%；上海乾刚持有公司股份 1,027,520 股，占公司总股本的比例为 0.1587%。 上述股份为公司首次公开发行股票并上市前取得的股份，及公司实施资本公 ...

有目前累计合作的一个科研课题组的话是超过1万家的然后以及11万家的一个病毒载体的包装经验以及5万家的一个病毒载体库以及GMP级别的病毒包装指令 然后在CMO业务这一块的话是累计服务的话是精英治疗CMO项目的话是超过330个的以及累计客户户的一个全球多地的一个ANDP件是36个其中11个是美国APPDA的一个P件然后以及240项的一个工艺开发项目以及600家的一个分析方法开发项目以及我们的5000平的一个综合研发平台和顶档的一个77000平的一个GMP的一个生产基地 然后这是我们的一个CIO业务的话其实是稳定增长的这样一个趋势可以看到就是二三年也好同时二三年QA的话也是呈现一个增长的这样一个趋势与国内的一些大量顶级的研发实验室去合作然后业务稳定增长然后在CMO这一块的话是全面覆盖基因治疗市场的一个产品线包括像AV、LV、OV、mRNA、指粒、CAR-T、干细胞、NK细胞等等 然后的话23年全年新建订单是超过2.5个亿然后24年QA的话是超过8000万的 然后在二三年的话就是我们的六月和九月的话我们的一个GMP的一个慢病毒包装指令和一个性相关病毒的话指令是成功获得美国FDA的一个备案然后它是可以在后续的一个相关的 ...

Investor Relations and Shareholder Management - The company emphasizes the importance of investor relations management, establishing a comprehensive system to protect the rights of investors, especially small and medium-sized shareholders[10] - The company has committed to not transferring or managing shares held before the IPO for 36 months post-listing, ensuring stability for shareholders[22] - If the stock price falls below the IPO price for 20 consecutive trading days within the first 6 months, the lock-up period for shares will automatically extend by 6 months[24] - New shareholders have committed to adhering to lock-up arrangements and legal regulations regarding share reductions[28] - The strategic placement of shares has a lock-up period of 24 months from the IPO date, aligning with regulatory requirements[43] - The company has a commitment from core technical personnel to limit share transfers to 25% of their holdings annually during their tenure[41] - The company committed to a 12-month lock-up period for shares acquired through strategic placement starting from the IPO date[45] - The company has established a diverse communication mechanism with investors, including performance briefings and research exchanges, to enhance transparency[10] - The company emphasizes the importance of investor awareness regarding the risks associated with forward-looking statements in the report[77] Financial Performance and Audit - The company reported a total of 21 new domestic trademark applications during the period, with 19 trademarks granted, including 16 domestic and 2 international trademarks[68] - The company’s audit fees for 2023 were set at 500,000 yuan, with a 20% decrease compared to the previous year[64] - The company has not reported any non-operating fund occupation by major shareholders during the reporting period[63] - The company has not made any changes to its accounting policies or estimates that would significantly impact its financial statements[63] - The company has not reached its original profit forecast for any assets or projects during the reporting period[63] - The company reported a negative net profit and cumulative undistributed profits for 2023, leading to no cash dividends or stock bonuses being distributed[75] - The board of directors has confirmed the accuracy and completeness of the annual report, ensuring no misleading statements or omissions[73] - In 2023, the company's operating revenue was CNY 204.81 million, a decrease of 29.69% compared to CNY 291.30 million in 2022[90] - The net profit attributable to shareholders was a loss of CNY 127.94 million, down 425.90% from a profit of CNY 39.26 million in the previous year[90] - The net cash flow from operating activities was a negative CNY 90.12 million, a decrease of 520.65% compared to CNY 21.42 million in 2022[90] - The company's total assets increased by 4.29% to CNY 2.60 billion at the end of 2023, compared to CNY 2.50 billion at the end of 2022[90] - The net assets attributable to shareholders decreased by 5.22% to CNY 2.06 billion at the end of 2023, down from CNY 2.17 billion at the end of 2022[90] - The basic earnings per share for 2023 was -CNY 0.199, a decrease of 406.15% from CNY 0.065 in 2022[90] - The company faced challenges in the domestic CDMO business due to external factors, leading to a rapid decline in revenue and increased operational costs[92] - The company implemented a capital reserve conversion to increase share capital, distributing 3 shares for every 10 shares held[92] - The company plans to continue expanding its production base and increasing R&D investment despite current financial challenges[92] Research and Development - R&D expenses for the current year amounted to ¥50,916,965.60, representing a significant increase of 46.20% compared to the previous year's ¥34,827,524.96[70] - The total R&D expenditure accounted for 24.86% of operating revenue, an increase of 12.90 percentage points from the previous year[71] - The increase in R&D investment is attributed to the company's focus on optimizing virus packaging systems, developing new viral vectors, and advancing technologies in mRNA and exosomes[71] - The company has expanded its internal R&D team and projects to enhance its capabilities in cutting-edge non-viral vector development and cell culture technology[71] - There were no significant changes in the proportion of capitalized R&D expenses[70] - The company has established a comprehensive technical platform, including a 5,000 square meter R&D center and a 77,000 square meter precision medical industrial base[100] - The company is focusing on expanding its service capabilities in the cell and gene therapy technology service sector[127] - The company is actively exploring new markets and product offerings to enhance its market share in the gene therapy industry[128] - The company has invested a total of 834 million yuan in the Lingang Industrial Base project, with an additional 369 million yuan invested in the current year, aiming to meet the growing global demand for gene therapy CDMO services[132] - The first phase of the Lingang Industrial Base has added GMP capacity, including 11 carrier production lines, 18 cell production lines, and 3 filling lines, with some capacity already operational since September 2023[132] - The company focuses on providing CRO and CDMO services for gene therapy, including the development of gene therapy vectors and GMP production for clinical samples[136] - The company has filed 40 new patents and trademarks, with 12 new patents granted, including 1 invention patent, bringing the total number of authorized patents to 38[133] - The workforce has expanded from 631 employees at the end of the previous year to 731 employees by the end of the reporting period, enhancing the company's operational capabilities[133] Market and Industry Trends - The gene therapy market is experiencing rapid growth, supported by national policies and increasing investment, with a focus on CAR-T products and other innovative therapies[137] - The company aims to establish a large-scale, flexible GMP production system for various gene drugs, enhancing its service offerings in the gene therapy sector[137] - The cell and gene therapy industry is still in a growth phase, influenced by macroeconomic factors, investment environments, and clinical application processes[154] - The commercialization process of cell and gene therapy products is accelerating, with significant approvals in various countries in 2023[157] - In 2023, the global sales of cell and gene therapy products are expected to reach USD 7.4 billion, with a compound annual growth rate (CAGR) of over 43.5% from 2021 to 2028, potentially growing to nearly USD 50 billion by 2028[185] - As of the end of 2023, there are over 3,951 gene therapy pipelines globally, with 2,111 in gene therapy and 313 projects in Phase II or later[181] - In 2023, a total of 12 cell and gene therapy products were approved for marketing in various countries, including 4 products approved in China[180] - The company is actively participating in the rapid commercialization of innovative therapies, with a focus on meeting unmet clinical needs in the healthcare sector[180] - The Chinese government continues to enhance support for the cell and gene therapy industry, with policies emphasizing the importance of innovative drug development and the establishment of a "biopharmaceutical supporting industry" concept[187] - The National Healthcare Security Administration's new rules for negotiated drug renewals and pricing mechanisms are expected to stabilize the pricing environment for innovative drugs, promoting long-term growth in the sector[190] - The cell and gene therapy industry is characterized by a diverse range of products, including AAV-based gene therapies and CAR-T cell therapies, which are expanding the treatment options available for various diseases[195] - Ongoing development of gene therapy products is covering multiple therapeutic areas, including oncology, rare diseases, and neurological disorders, ensuring a broad clinical application spectrum[196] - The Chinese government has issued multiple policies in 2023 to enhance the regulatory framework for cell and gene therapy, promoting a healthy and orderly development of the industry[192] - Local governments, such as Beijing and Shanghai, have implemented specific action plans to foster innovation and industrial development in gene therapy, with a focus on enhancing clinical research capabilities[189] - The introduction of new technologies, such as mRNA products and exosome drug carriers, is continuously enriching the types of gene therapy products available in the market[195] - The emphasis on collaborative therapies, such as combining oncolytic viruses with CAR-T treatments, is providing better efficacy for patients and supporting the overall health of the industry[195] Outsourcing and Collaboration - 54% of surveyed cell and gene therapy companies expressed a willingness to outsource GMP production, significantly higher than the 34% in traditional life sciences[200] - The complexity of gene therapy product development necessitates high-level services from CRO/CDMO organizations, which are becoming key players in the industry[200] - The demand for specialized CRO/CDMO services in gene therapy is driven by the need for advanced technical expertise and regulatory compliance[200] - Continuous entry of startup biotech companies into the gene therapy sector is fueled by emerging technologies and new targets[199] - The majority of gene therapy companies prefer outsourcing drug research and production to specialized CRO/CDMO firms due to various operational constraints[200] - Academic institutions and research organizations play a crucial role in the initial research and development of gene therapy products[199] - The rapid growth of the cell and gene therapy industry is supported by the momentum from foundational research and innovative technology development[199]

问询函专项说明 天健函〔2024〕6-64 号 上海证劵交易所： 由和元生物技术（上海）股份有限公司（以下简称和元生物公司或公司）转 来的 《 关于和元生物技术（上海）股份有限公司 2023 年年度报告的信息披露监 管问询函》（上证科创公函〔2024〕0152 号，以下简称问询函）奉悉。我们已 对问询函中需要我们说明的财务事项进行了审慎核查，现汇报说明如下。 若无特殊说明，以下单位均为万元。本说明中若明细项目金额加计之和与小 计数存在尾差，系四舍五入所致。 限公司2023年年报问询函的 关于和元生物技术（上海）股份 专项说明 目 录 | 一、关于经营业绩…………………………………………………第 | | 1—18 | 页 | | --- | --- | --- | --- | | 二、关于募投项目和新建产能………………………………… | 第 | 19—22 | 页 | | 三、关于其他…………………………………………………… | 第 | 22—32 | 页 | 一、关于经营业绩 1. 年报显示，2023 年度，公司基因治疗 CDMO 业务毛利率为-67.76%，同比 减少 105.55 个百分点。 请公司说明： ...