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 年度持续督导年度跟踪报告 | 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.SH | 重大事项提示 2023 年度，公司实现营业收入 20,480.50 万元，同比下降 29.69%；实现归 属于母公司所有者的净利润-12,793.83 万元，同比下降 425.90%；实现归属于母 公司所有者的扣除非经常性损益的净利润-13,354.89 万元，同比下降 476.11%； 经营活动产生的现金流量净额-9,012.18 万元，同比减少 520.65%，2023 年公司 业绩由盈转亏，主要由于报告期内持续受外部环境等因素影响，国内基因细胞行 业下游客户融资不畅，导致公司国内 CDMO 业务同比下降，且公司因临港基地 投产、团队规模扩大、研发投入增加等导致运营成本大幅增长，营业毛利和净利 润下降，经营活动产生现金流量净额减少。未来如果国内市场景气度回暖不及预 期，生物医药投融资环境持续低迷，下游 CGT CDMO 客户新药研发 ...

Investment Rating - The report maintains a "Cautious Recommendation" rating for the company [10][11]. Core Insights - The company reported a revenue of 205 million yuan in 2023, a year-on-year decrease of 29.69%, with a net profit attributable to shareholders of -128 million yuan, down 425.9% year-on-year [10]. - In Q1 2024, the company achieved a revenue of 60 million yuan, representing a year-on-year growth of 93.48%, although the net profit was still negative at -42 million yuan [10]. - The CRO segment showed stable growth with a revenue of 79 million yuan in 2023, up 20.56% year-on-year, while the CDMO segment faced challenges with a revenue of 107 million yuan, down 50.64% year-on-year [10]. - The company has made significant progress in expanding its production capacity with the operational launch of its GMP production base in Lingang, which includes a 77,000 m² precision medical industrial base and multiple production lines [10]. - R&D expenditure increased by 46.20% in 2023, totaling 50.9 million yuan, indicating a focus on enhancing core competitiveness through innovation [10]. Financial Forecasts - The forecasted revenues for 2024, 2025, and 2026 are 251 million yuan, 306 million yuan, and 371 million yuan respectively, with growth rates of 22.31%, 22.04%, and 21.40% [2][13]. - The net profit attributable to shareholders is projected to improve from -103 million yuan in 2024 to 18 million yuan in 2026 [2][13]. - The company is expected to gradually increase its capacity utilization, with a forecasted EBITDA turning positive by 2025 [10][13].

Financial Performance - The company's operating revenue for Q1 2024 was ¥59,574,128.09, representing a year-on-year increase of 93.48%[4] - The net profit attributable to shareholders was -¥42,170,292.32, indicating a significant loss compared to the previous year[4] - The net cash flow from operating activities was -¥62,542,304.19, reflecting increased operational costs due to expanded scale[4] - Basic and diluted earnings per share were both -¥0.0658, showing a decline compared to the previous year[5] - The company's net loss for Q1 2024 was ¥86,384,292.08, compared to a loss of ¥44,213,999.76 in Q4 2023, indicating a worsening financial position[28] - The net profit for Q1 2024 was -42,298,770.28 RMB, compared to -31,806,061.95 RMB in Q1 2023, representing an increase in net loss of approximately 33.5%[31] - The total comprehensive income for Q1 2024 was -42,736,982.02 RMB, compared to -31,926,525.95 RMB in Q1 2023, indicating a decline of about 33.9%[32] - Basic and diluted earnings per share for Q1 2024 were both -0.0658 RMB, compared to -0.0495 RMB in Q1 2023, reflecting a worsening in earnings per share[32] Revenue Breakdown - The increase in operating revenue was primarily driven by growth in the cell and gene therapy CDMO business[10] - The revenue from cell gene therapy CRO business was RMB 17.96 million, an increase of 30.98% compared to the same period last year[20] - The revenue from cell gene therapy CDMO business reached RMB 38.21 million, showing a significant growth of 146.50% year-on-year[20] - The company achieved a total revenue of RMB 59.57 million in the reporting period, representing a year-on-year growth of 93.48%[20] - Total operating revenue for Q1 2024 reached ¥59,574,128.09, a significant increase of 93.6% compared to ¥30,791,377.00 in Q1 2023[30] Costs and Expenses - Total operating costs for Q1 2024 were ¥117,835,749.83, up from ¥64,195,944.08 in Q1 2023, reflecting a year-over-year increase of 83.7%[30] - Research and development expenses totaled ¥13,787,220.55, accounting for 23.14% of operating revenue, a decrease of 13.46 percentage points year-on-year[5][11] - Research and development expenses for Q1 2024 were ¥13,787,220.55, compared to ¥11,269,831.53 in Q1 2023, marking an increase of 22.4%[30] Assets and Liabilities - Total assets at the end of Q1 2024 were ¥2,568,964,189.92, down 1.33% from the end of the previous year[5] - The company's total liabilities increased to ¥552,392,907.97 from ¥545,124,164.98, reflecting a rise of 1.5%[28] - Total assets as of March 31, 2024, amounted to ¥2,568,964,189.92, a slight decrease from ¥2,603,492,225.50 at the end of 2023[29] - The total current assets as of March 31, 2024, were 1,201,276,304.58 RMB, an increase from 1,117,716,144.41 RMB as of December 31, 2023, indicating growth in liquidity[37] Cash Flow - Cash flow from operating activities showed a net outflow of -62,542,304.19 RMB in Q1 2024, compared to -32,994,071.49 RMB in Q1 2023, indicating a significant increase in cash burn[35] - Cash and cash equivalents decreased to ¥566,941,878.98 as of March 31, 2024, down from ¥657,048,399.97 at the end of 2023, a decline of 13.7%[26] - The company reported a total cash inflow from financing activities of 60,000,000.00 RMB in Q1 2024, down from 140,205,000.00 RMB in Q1 2023, reflecting a decrease of approximately 57.3%[35] Strategic Developments - The company secured new orders exceeding RMB 80 million during the reporting period[20] - The company assisted clients in obtaining 4 IND approval filings in China and the U.S., including 1 from the FDA, bringing the total to 36 approvals[20] - The company and its subsidiaries added 2 new authorized invention patents and 1 utility model patent during the reporting period, totaling 25 invention patents and 16 utility model patents[21] - The company invested RMB 6 million in an industry investment fund, which was registered in January 2024[22] - The company established two wholly-owned subsidiaries in January and February 2024, each with a registered capital of RMB 500,000[21] Employee Engagement - The first employee stock ownership plan was announced, indicating a strategic move to enhance employee engagement and retention[24]

和元生物技术（上海）股份有限公司 第三届董事会独立董事专门会议第二次会议决议 会议时间：2024 年 4 月 23 日上午 9:00-9:15 会议地点：上海市浦东新区国际医学园区紫萍路 908 弄 19 号楼会议室 召集人：独立董事 GANG WANG（王刚）先生 主持人：独立董事 GANG WANG（王刚）先生 和元生物技术（上海）股份有限公司（以下简称"公司"）第三届董事会独 立董事专门会议第二次会议于 2024 年 4 月 23 日上午 9:00-9:15 在公司会议室 召开。本次会议应到独立董事 3 名，实到独立董事 3 名，符合《中华人民共和国 公司法》和《和元生物技术（上海）股份有限公司章程》等相关规定。会议由独 立董事 GANG WANG（王刚）先生主持，以记名投票方式进行表决，审议通过了如 下议案： 一、 审议通过《关于<2023 年度募集资金存放与实际使用情况的专项报 告>的议案》 1、议案内容： 根据《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》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 有关规定，公司董事会编制了《和元生物技术（上海 ...

目 录 和元生物技术（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的 专项审计说明 | 一、非经营性资金占用及其他关联资金往来情况的专项 | | | --- | --- | | 审计说明…………………………………………………………第 | 1—2 页 | | 二、非经营性资金占用及其他关联资金往来情况汇总表 ……………第 | 3 页 | | 三、本所营业执照复印件……………………………………………… | 第 4 页 | | 四、本所执业证书复印件……………………………………………… | 第 5 页 | | 五、签字注册会计师执业证书复印件………………………………第 | 6-7 页 | 非经营性资金占用及其他关联资金往来情况的 专项审计说明 天健审〔2024〕6-217 号 一、对报告使用者和使用目的的限定 本报告仅供和元生物公司年度报告披露时使用，不得用作任何其他目的。我 们同意将本报告作为和元生物公司年度报告的必备文件，随同其他文件一起报送 并对外披露。 为了更好地理解和元生物公司 2023 年度非经营性资金占用及其他关联资金 往来情况，汇总表应当与已审的财务报表一并阅读。 二、管理层的责任 和 ...

和元生物技术（上海）股份有限公司 2023 年度独立董事述职报告（宋正奇） 和元生物技术（上海）股份有限公司 2023 年度独立董事述职报告 作为和元生物技术（上海）股份有限公司（以下简称"公司"）第三届董事 会的独立董事，2023 年度，本人严格按照《上市公司独立董事管理办法》《和元 生物技术（上海）股份有限公司章程》（以下简称"《公司章程》"）、《和元生 物技术（上海）股份有限公司独立董事工作细则》（以下简称"《独立董事工作细 则》"）等有关法律、法规的规定，诚信、勤勉地履行独立董事的职责。2023 年度， 本着对公司及全体股东负责的态度，以关注和维护全体股东特别是中小股东利益 为宗旨，积极参与公司决策，对公司治理结构的完善和促进规范运作起到了积极 作用。现将具体工作情况汇报如下： 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 本人宋正奇，男，1981 年 2 月出生，中国国籍，无境外永久居留权，本科学 历。2004 年 3 月至 2008 年 1 月，先后担任上海市金茂律师事务所律师助理、律 师；2008 年 1 月至 2012 年 9 月，先后担任上海金茂凯德律师事务所律师、合伙 ...

Financial Performance - The company reported a significant decline in CDMO business orders and revenue due to a slowdown in investment in the biopharmaceutical sector, resulting in a negative gross margin and net profit for the CDMO business[4]. - The company’s net profit and accumulated undistributed profits for 2023 were both negative, leading to a decision not to distribute cash dividends or issue bonus shares[6]. - The company's operating revenue for 2023 was CNY 204.81 million, a decrease of 29.69% compared to CNY 291.30 million in 2022[23]. - The net profit attributable to shareholders for 2023 was CNY -127.94 million, representing a decline of 425.90% from CNY 39.26 million in 2022[23]. - The basic earnings per share for 2023 was CNY -0.199, down 406.15% from CNY 0.065 in 2022[24]. - The net cash flow from operating activities for 2023 was CNY -90.12 million, a decrease of 520.65% from CNY 21.42 million in 2022[23]. - The company's 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[23]. - The weighted average return on equity for 2023 was -6.05%, a decrease of 8.18 percentage points from 2.13% in 2022[24]. - The company recorded a significant increase in operating costs, which rose by 34.76% to CNY 218.22 million compared to the previous year[172]. - The gross margin for the CDMO business turned negative, influenced by increased operational costs and a ramp-up period for the new industrial base[178]. Market Expansion and Strategy - The company plans to expand its domestic and international markets by acquiring new clients and exploring new business areas to enhance competitiveness and profitability[4]. - The company is expanding its market presence in Europe, targeting a 15% market share within the next two years[14]. - The company is actively taking measures to reduce costs and increase efficiency in response to the challenging market environment[4]. - The company aims to improve order quantity and scale by leveraging its comprehensive business capabilities, diverse technologies, and rich project experience[4]. - The company is focused on expanding its market presence and enhancing its core technology capabilities despite external challenges[38]. - The company is actively expanding its overseas market presence, enhancing its influence in the US through industry exhibitions and academic presentations[91]. - The company is investing heavily in R&D, with a budget increase of 20% compared to the previous year[200]. - Market expansion efforts include entering three new international markets, aiming for a 25% increase in market share[200]. Research and Development - Increased operational costs were attributed to higher R&D investments, extended project execution cycles, and the official launch of the Lingang industrial base[4]. - Research and development expenses accounted for 24.86% of operating revenue in 2023, an increase of 12.90 percentage points from 11.96% in 2022[24]. - R&D expenditure for the reporting period was 50.917 million yuan, an increase of 46.20% compared to the same period last year[40]. - The company has established a robust bioinformatics data analysis platform, integrating various tools and algorithms for efficient processing of biological data[123]. - The R&D team has been expanded to support internal projects and enhance overall research capabilities[134]. - The company has developed CRISPR gene editing cell therapy products and exosome production processes, which have entered GMP production[147]. - The company has developed multiple analytical methods to improve precision and accuracy in gene delivery assessments[140]. - The company has received 1 new invention patent and 11 utility model patents during the reporting period, bringing the total to 23 invention patents and 15 utility model patents[129]. Product Development and Innovation - New product launches include a gene therapy platform expected to enter clinical trials by Q3 2024, with an estimated market potential of $500 million[14]. - The company has established a new cell bank facility to enhance its production capabilities, expected to be operational by Q2 2024[14]. - The company has developed a high-efficiency codon optimization tool that enhances protein expression stability, showing promising results in preliminary experiments[123]. - The company has successfully completed the world's first 2000L large-scale AAV virus production test, significantly enhancing AAV production capacity and accessibility for in vivo applications[147]. - The company has developed a new AAV vector specifically targeting pulmonary endothelial cells and a highly efficient lentiviral vector for NK cell infection, achieving industry-leading standards[147]. - The company has developed over 600 detection methods, including more than 45 specific methods for quality testing of viral samples, establishing a high-standard detection system[128]. Industry Trends and Challenges - The company emphasizes the importance of cell and gene therapy as a key development direction in the biopharmaceutical industry, supported by national industrial policies[4]. - The gene therapy market is supported by national policies, leading to increased investment and growth in the CRO/CDMO industry[44]. - The cell and gene therapy industry is still in its growth phase, influenced by macroeconomic factors and the funding environment, with many startups showing varied capabilities[56]. - The competitive landscape in the gene therapy CDMO field is intensifying, with increased investments and new entrants posing challenges[162]. - The company faces potential risks of performance decline due to a slowdown in investment in the biopharmaceutical sector and increased operational costs from new technology development and team expansion[159]. - The domestic CDMO sector faces challenges with over 35 disclosed companies as of 2023, leading to potential overcapacity in the gene therapy industry[105]. Governance and Compliance - The company’s board of directors and management have confirmed the accuracy and completeness of the annual report, ensuring no misleading statements or omissions[5]. - The company has updated its internal governance structure to ensure compliance and protect the rights of minority investors[42]. - The company emphasizes strict IP protection by avoiding independent drug development, ensuring client data security throughout the business process[153]. - The company has a comprehensive IP protection system built on digital and intelligent technologies, ensuring data security and confidentiality for clients[153]. Future Outlook - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $180 million[14]. - The company anticipates that advancements in technology and clinical experience will enhance the role of cell and gene therapies in treating various serious diseases[57]. - The company has established a comprehensive CRO/CDMO technology platform, including molecular biology, virus vector packaging, and quality control technology research platforms[149].

和元生物技术（上海）股份有限公司 关于 2021 年股票期权激励计划第二个行权期 行权条件成就的公告 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： 和元生物技术（上海）股份有限公司（以下简称"公司"）于 2024 年 4 月 23 日召开第三届董事会第十三次会议和第三届监事会第九次会议，分别审议通 过了《关于 2021 年股票期权激励计划第二个行权期行权条件成就的议案》，公司 股票期权激励计划第二个行权期行权条件已经成就（以下简称"本次行权"），现 将相关事项公告如下： 证券代码：688238 证券简称：和元生物 公告编号：2024-022 公司于 2021 年 3 月 15 日，召开第二届监事会第十次会议，审议通过了上述 《激励计划》《激励对象》的议案。 2021 年 3 月 25 日，公司监事会出具了《关于公司 2021 年股票期权激励计 划及激励对象人员名单的核查意见》，监事会认为公司具备实施股权激励计划的 主体资格；激励对象符合相关法律、法规及规范性文件所规定的条件，其作为本 次股票期权激励计划激 ...

和元生物技术（上海）股份有限公司 内部控制审计报告 目 录 | 一、内部控制审计报告…………………………………………… | 第 | 1—2 | 页 | | --- | --- | --- | --- | | 二、本所营业执照复印件………………………………………………第 | | | 3 页 | | 三、本所执业证书复印件………………………………………………第 | | | 4 页 | | 四、签字注册会计师执业证书复印件…………………………… | 第 | 5-6 | 页 | 内部控制审计报告 天健审〔2024〕6-216 号 和元生物技术（上海）股份有限公司全体股东： 按照《企业内部控制审计指引》及中国注册会计师执业准则的相关要求，我 们审计了和元生物技术（上海）股份有限公司（以下简称和元生物公司）2023 年 12 月 31 日的财务报告内部控制的有效性。 一、企业对内部控制的责任 按照《企业内部控制基本规范》《企业内部控制应用指引》以及《企业内部 控制评价指引》的规定，建立健全和有效实施内部控制，并评价其有效性是和元 生物公司董事会的责任。 二、注册会计师的责任 三、内部控制的固有局限性 内部控制具有固有局限 ...

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 关于 2023 年度募集资金存放与实际使用情况的 专项报告 证券代码：688238 证券简称：和元生物 公告编号：2024-017 的有效实施，上述监管协议与上海证券交易所的监管协议范本不存在重大差异， 监管协议的履行不存在问题。同时公司严格按照相关法律法规和规范性文件的要 求及时履行信息披露义务。具体情况详见 2022 年 3 月 21 日披露于上海证券交易 所网站（www.sse.com.cn）的《首次公开发行股票科创板上市公告书》。 （二）实际募集资金的使用及结余情况 截至 2023 年 12 月 31 日，公司募集资金余额为 269,094,176.43 元，其中募 集资金专户余额 116,094,176.43 元 ， 用于现金管理的募集资金余额 153,000,000.00 元。募集资金的使用及结余情况具体如下： 二、募集资金存放和管理情况 根据中国证券监督管理委员会（以下简称"中国证监会"）发布的《上市公 司监管指引第 2 号—— ...