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 ...

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： ...

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]

证券代码：688238 证券简称：和元生物 公告编号：2024-033 和元生物技术（上海）股份有限公司 关于 2023 年年度报告的信息披露监管问询函的 回复公告 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。 和元生物技术（上海）股份有限公司（以下简称"公司"）于近日收到上海 证券交易所下发的《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"监管问询 函"）。公司及年审会计师、持续督导机构高度重视，对监管问询函所提出的问 题进行了认真核查和分析，现做回复如下： 回复中部分合计数与各项目直接相加之和可能存在尾数差异，这些差异是 由四舍五入造成的。如无特别说明，本回复中使用的简称、名词释义与《和元 生物技术（上海）股份有限公司 2023 年年度报告》一致。 由于涉及公司商业秘密及商业敏感信息，根据相关法律法规、规范性文件 及《和元生物技术（上海）股份有限公司信息披露暂缓与豁免事务管理制度》 的有关规定，公司已履行相应信息豁免披露程序，对本次 ...

海通证券股份有限公司 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的核查意见 上海证券交易所： …… 请持续督导机构说明近年对募集资金使用情况的监管情况及核查结论。 问题回复： （一）公司募集资金使用情况 根据中国证券监督管理委员会《关于同意和元生物技术（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〔2022〕61 号），公司由主承销海 通证券采用余额包销方式，向社会公众公开发行人民币普通股（A 股）股票 100,000,000 股，发行价为每股人民币 13.23 元，共计募集资金 132,300.00 万元， 坐扣承销费、保荐费（不含税）9,379.50 万元后的募集资金为 122,920.50 万元， 已由海通证券于 2022 年 3 月 17 日汇入公司募集资金监管账户。另减除律师费、 1 审计及验资费、信息披露费用、发行手续费用 3,174.06 万元（不含税）后，公司 本次募集资金净额为 119,746.44 万元。上述募集资金到位情况业经天健会计师事 务所（特殊普通合伙）验证，并由其出具《验资报告》（天健验〔2022〕6-10 号）。 海通证券股份 ...

Investment Rating - The report adjusts the investment rating to "Accumulate" [10][12] Core Views - The company reported a revenue of 205 million yuan in 2023, a year-on-year decrease of 29.69%, and a net profit attributable to the parent company of -128 million yuan, a year-on-year decline of 425.90% [1] - The CRO business continues to grow, while the CDMO business maintains its leading position [2][11] - The company has established a comprehensive production line for gene therapy vectors and various cell therapy production lines, with the first phase of capacity officially operational since September 2023 [10][26] Financial Performance Summary - In Q1 2024, the company reported a revenue of 60 million yuan, a year-on-year increase of 93.48%, but a net profit attributable to the parent company of -42 million yuan, a year-on-year decrease of 32.85% [1] - The gross margin for 2023 was -6.55%, a decrease of 50.96 percentage points year-on-year, while the net margin was -62.41%, a decrease of 75.81 percentage points year-on-year [1] - The company expects revenues of 252 million yuan, 304 million yuan, and 371 million yuan for 2024, 2025, and 2026 respectively, with net profits projected at -126 million yuan, -58 million yuan, and -15 million yuan for the same years [10][17] Business Development Summary - The company has assisted clients in obtaining 32 IND approvals in China and the US, with over 330 CDMO projects and new orders exceeding 250 million yuan [11] - The company is actively expanding its overseas market presence and increasing R&D investment [25]

证券代码：688238 证券简称：和元生物 公告编号：2024-031 和元生物技术（上海）股份有限公司 关于子公司完成工商变更登记 并换发营业执照的公告 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。 和元生物技术（上海）股份有限公司（以下简称"公司"）根据业务发展 规划，决定以自有资金对全资子公司和元和美（上海）生物技术有限公司（以 下简称"和元和美"）进行增资，增资后注册资本为人民币5,000.00万元。和 元和美主要从事医疗健康相关应用领域的各类细胞及外泌体、细胞因子等细 胞衍生物CRO/CDMO业务。 近日，和元和美已完成上述事项的工商变更登记和备案手续，并取得了由 中国（上海）自由贸易试验区临港新片区市场监督管理局颁发的《营业执照》， 变更后的相关工商登记信息如下： 名称：和元和美（上海）生物技术有限公司 统一社会信用代码：91310000MADJ8J3025 类型：有限责任公司（自然人投资或控股的法人独资） 法定代表人：潘俊屹 注册资本：人民币5,000.0000万元整 成立日期：2024年4月25日 住所： ...

根据《关于上市公司实施员工持股计划试点的指导意见》和《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》等相关规定，现将第一期 员工持股计划（以下简称"本次员工持股计划"）实施进展情况公告如下： 截至 2024 年 5 月 30 日，本次员工持股计划已完成公司股票购买，通过二级 市场购买的方式累计买入公司股票 5,508,413 股，占公司当前总股本的 0.8508%， 成交均价为 5.6261 元/股，成交总金额为 30,990,802.88 元。上述股票将按照本 次员工持股计划的相关规定予以锁定，锁定期为 12 个月，即自 2024 年 5 月 31 日至 2025 年 5 月 30 日止。 公司将按照相关法律、法规、规范性文件及业务规则的要求，及时履行信息 披露义务。敬请广大投资者关注相关公告，注意投资风险。 1 证券代码：688238 证券简称：和元生物 公告编号：2024-032 和元生物技术（上海）股份有限公司 关于第一期员工持股计划完成股票购买的公告 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 ...