证券代码：688062 证券简称：迈威生物 公告编号：2025-011 迈威（上海）生物科技股份有限公司 关于续聘公司 2025 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），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2024年末拥有合伙人251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2024年末拥有执业注册会计师逾1700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1500人，注册会计师中签 署过证券服务业务审计报告的注册会计师逾500人。安永华明2023年度业务总收 入人民币59.55亿元，其中，审计业务收入人民币55.85亿元，证券业务收入人民 币24.38亿元。2023年度A股 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-014 迈威（上海）生物科技股份有限公司 关于全资子公司向金融机构申请授信及融资额度并 由公司为其提供担保额度预计的公告 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： 被担保人名称：迈威（上海）生物科技股份有限公司（以下简称"公司" 或"迈威生物"）的全资子公司（直接或间接持有 100%股权的子公司）江苏泰 康生物医药有限公司（以下简称"泰康生物"）、上海朗润迈威生物医药科技有 限公司（以下简称"朗润迈威"）、江苏迈威药业有限公司（以下简称"江苏迈 威"）、江苏迈威康新药研发有限公司（以下简称"迈威康"）、迈威（重庆） 生物医药有限公司（以下简称"迈威重庆"）及迈威视医药科技（浙江）有限公 司（以下简称"迈威视"）。 上述全资子公司拟向金融机构申请授信及融资额度，并由公司为其提供 担保，预计担保总额不超过人民币 31 亿元，具体担保金额、担保期限、担保方 式等内容以正式签署的担保文件为准。以上担保额度不等于上述全资子公司的实 际融资金额。 公 ...

迈威（上海）生物科技股份有限公司 2025年度"提质增效重回报"行动方案 迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"） 为秉持"投资者至上"的发展宗旨，维护全体股东利益，推动企业不断优化运营 管理、规范公司治理，并致力于为投资者创造价值，全面提升公司质量，基于对 公司未来发展的坚定信念、对公司价值的充分认可，以及认真履行社会责任的承 诺，特制定 2025 年度"提质增效重回报"行动方案。具体方案如下： 一、聚焦主营创新药研发，面向全球加快开发差异化创新药 公司自科创板上市以来，基于全产业链布局，始终围绕专注领域深度布局， 积极推进在研品种研发。公司目前拥有 16 个处于临床前、临床或上市阶段的核心 品种，包括 12 个创新药，4 个生物类似药，专注于肿瘤和年龄相关疾病，如免疫、 眼科、骨科等领域。其中，已上市品种 3个，包括：迈利舒®（9MW0311，地舒单 抗注射液）、迈卫健®（9MW0321，地舒单抗注射液）、君迈康®（9MW0113，阿 达木单抗注射液），处于上市许可审评阶段品种 1 个，提交上市许可申请前（pre- NDA）沟通交流会议申请阶段的品种 1 个，处于 III 期关键 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-019 （一） 股东大会类型和届次 2024 年年度股东大会 召开日期时间：2025 年 4 月 21 日 15 点 00 分 召开地点：上海市浦东新区李冰路 576 号创想园 3 号楼 103 会议室 （五） 网络投票的系统、起止日期和投票时间。 网络投票系统：上海证券交易所股东大会网络投票系统 网络投票起止时间：自 2025 年 4 月 21 日 迈威（上海）生物科技股份有限公司 关于召开 2024 年年度股东大会的通知 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 至 2025 年 4 月 21 日 采用上海证券交易所网络投票系统，通过交易系统投票平台的投票时间为股 东大会召开当日的交易时间段，即 9:15-9:25,9:30-11:30，13:00-15:00；通过互联 网投票平台的投票时间为股东大会召开当日的 9:15-15:00。 股东大会召开日期：2025年4月21日 本次股东大会采用的网络投票系统：上海 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-018 迈威（上海）生物科技股份有限公司 第二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。 一、监事会会议召开情况 迈威（上海）生物科技股份有限公司（以下简称"公司"）第二届监事会 第十六次会议通知于 2025 年 3 月 20 日以书面方式送达全体监事，于 2025 年 3 月 30 日以现场结合通讯方式召开。会议由监事会主席楚键先生主持，会议应到 监事 3 人，实到监事 3 人。会议的召集、召开程序和方式符合《公司法》等法 律法规以及《迈威（上海）生物科技股份有限公司章程》（以下简称"公司章 程"）的有关规定，会议决议合法、有效。 二、监事会会议审议情况 （一）审议通过《关于公司<2024年年度报告>及摘要的议案》 经审议，监事会认为年度报告的编制、审议程序符合相关法律法规及规范 性文件的规定和要求，年度报告的内容真实、准确、完整地反映了公司报告期 内的财务状况和经营成果，不存在虚假记载、误导性陈述或重大遗漏。 具体内容详见 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-017 迈威（上海）生物科技股份有限公司 第二届董事会第十七次会议决议公告 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、董事会会议召开情况 二、董事会会议审议情况 （一）审议通过《关于公司<2024年年度报告>及摘要的议案》 经审议，董事会认为 2024 年年度报告的编制、审议程序符合相关法律法规 及规范性文件的规定和要求，年度报告的内容真实、准确、完整地反映了公司 报告期内的财务状况和经营成果，不存在虚假记载、误导性陈述或重大遗漏。 具体内容详见与本公告同日刊登于上海证券交易所网站（www.sse.com.cn） 的《迈威（上海）生物科技股份有限公司 2024 年年度报告》及《迈威（上海） 生物科技股份有限公司 2024 年年度报告摘要》。 表决结果：9 票同意，0 票反对，0 票弃权。 本议案尚需提交至 2024 年年度股东大会审议。 （二）审议通过《关于审议2024年度<审计报告>的议案》 经审议，董事会同意《关于审议 2024 年度<审计报告> ...

Financial Performance - The company has not yet achieved profitability and has accumulated losses due to the short market presence of its three products and high R&D investments, totaling CNY 782.87 million in the reporting period, a decrease of 6.33% year-on-year [3]. - The company raised a net amount of CNY 3,303.43 million during its IPO on the Shanghai Stock Exchange in January 2022, relying on external financing for operational capital [4]. - The company does not plan to distribute cash dividends or increase capital through stock transfers for the 2024 fiscal year [11]. - The company reported a significant increase in revenue, achieving a total of $XX million, representing a YY% growth compared to the previous quarter [20]. - The company's operating revenue for 2024 reached ¥199,781,622.22, representing a year-on-year increase of 56.28% compared to ¥127,835,534.42 in 2023 [28]. - The net loss attributable to shareholders for 2024 was ¥1,043,919,217.28, a slight improvement from a loss of ¥1,053,432,676.66 in 2023 [28]. - The cash flow from operating activities showed a net outflow of ¥956,443,630.18, which increased from ¥782,728,279.34 in the previous year [28]. - The sales revenue from pharmaceutical products was ¥144,592,000, a significant increase of 243.53% from ¥42,089,600 in the previous year [31]. - The basic earnings per share for 2024 was -¥2.61, compared to -¥2.64 in 2023 [29]. - The company's total assets decreased by 4.03% to ¥4,275,508,853.05 in 2024 from ¥4,455,048,440.71 in 2023 [28]. - Research and development expenses accounted for 391.86% of operating revenue, a decrease of 261.93 percentage points from the previous year [29]. - The company received government subsidies amounting to ¥26,381,537.32 in 2024, which was higher than the ¥11,313,759.15 received in 2023 [35]. Research and Development - The company plans to continue significant R&D investments, with expenses of CNY 758.61 million, CNY 835.78 million, and CNY 782.87 million for the years 2022, 2023, and 2024 respectively [5]. - The company has 16 products in various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [3]. - The company has 13 products in its core pipeline, requiring continued substantial R&D investments for their development [6]. - The company emphasizes the importance of clinical value in drug development, aligning with recent regulatory guidelines to ensure that the benefits of new drugs outweigh the risks [9]. - The company is actively involved in the research and development of new drugs, including a new oral compound (1MW5011) derived from glucosamine [17]. - The company is committed to adhering to current Good Manufacturing Practices (cGMP) to ensure high-quality production standards [17]. - The company is exploring corrective and preventive actions (CAPA) to enhance its operational efficiency and product quality [17]. - The company has established four core ADC technologies, which enhance the safety and efficacy of its ADC products [81]. - The company employs a modular R&D model, utilizing wholly-owned subsidiaries for high-innovation projects to enhance management flexibility and R&D efficiency [192]. Product Development and Approvals - The company has three products commercialized and one under review for market approval, which is expected to improve financial conditions and facilitate a path to profitability [4]. - As of the report date, the company has 3 products approved for market, 1 under review for market approval, and 1 in the pre-NDA communication stage, with a focus on oncology and age-related diseases [41]. - The company received FDA approval for the clinical trial of 7MW3711 for advanced malignant solid tumors in February 2024, and 9MW3011 was granted orphan drug designation [41]. - In March 2024, 9MW0321 received approval from the National Medical Products Administration for treatment of bone giant cell tumors, marking it as the first approved biosimilar in China [41]. - 9MW2821 has received multiple designations from the FDA, including orphan drug status and fast track designation for various cancer treatments throughout 2024 [42][43]. - The company plans to further enhance its sales and marketing capabilities with 4 commercialized products expected by 2025 [40]. - The company is actively expanding its clinical research, with multiple ongoing Phase III trials for 9MW2821 targeting various cancers [44]. - The company has received FDA designations for 3 "Fast Track Designations" and 1 "Orphan Drug Designation" for its core pipeline product 9MW2821, indicating strong clinical data performance [73]. Market Expansion and Strategic Partnerships - The company is focused on expanding its market presence through strategic partnerships and collaborations, particularly in the development of antibody-drug conjugates (ADC) [17]. - The company aims to enhance its international brand influence by focusing on emerging markets such as South America and countries along the "Belt and Road" initiative, which have significant pharmaceutical market potential [66]. - The company has signed formal cooperation agreements with 16 countries for the product 9MW0113 and submitted registration applications in 5 countries, with more applications in preparation [69]. - The company has established a strategic partnership with a Saudi Arabian pharmaceutical company for product registration and commercialization in multiple countries in the Middle East and North Africa [68]. - The company is actively negotiating with multiple international pharmaceutical giants to maximize the value of its R&D pipeline through various collaboration models [71]. - The company has established an international business department and a business development department to promote overseas markets and global business cooperation [94]. Production and Quality Management - The company has completed the trial production of ADC drugs at its Taizhou production base, with 4 batches of raw ADC and 7 batches of formulations produced, all meeting quality standards [78]. - The Taizhou production base has completed the construction of antibody and recombinant protein drug production facilities, with a capacity of 8,000L for antibody drugs and 4,000L for recombinant protein drugs [196]. - The company has established a comprehensive quality management system based on Chinese GMP, US FDA cGMP, and EU EMA GMP standards, covering the entire product lifecycle [197]. - The company has achieved compliance with EU QP audit standards at the Jinshan production base, expected to be certified by January 2025 [199]. - The company has implemented a unified management system for procurement, enhancing visibility and traceability in the supply chain [193]. Clinical Trials and Patient Outcomes - 9MW2821 demonstrated an objective response rate (ORR) of 40.54% in recurrent or metastatic cervical cancer, with a disease control rate (DCR) approaching 90% [49]. - 9MW2821 is the first ADC to disclose clinical efficacy data in cervical and esophageal cancer among similar pipelines in the domestic market [48]. - The company has initiated a Phase III clinical study for 9MW2821 in combination with Toripalimab for first-line treatment of locally advanced or metastatic urothelial carcinoma, with a mid-term analysis planned for 2027 and NDA submission expected in 2027 [135]. - 9MW2821 has shown promising results in treating advanced esophageal squamous cell carcinoma, with an ORR of 23.1% and DCR of 69.2% in a Phase II trial [141]. - The company has completed patient enrollment for the Phase II/III clinical study of 9MW0211, which is currently in the follow-up stage [149]. - The company plans to complete the follow-up for 9MW0211 by the end of 2025 [149]. Innovative Drug Development - 1MW5011 is a potential first-in-class small molecule drug for osteoarthritis, showing promising preclinical efficacy and safety results [159]. - 9MW1911 is the first domestically developed macromolecule drug targeting the non-Th2 pathway, with two Phase I clinical trials completed in China, involving 76 healthy subjects, showing good safety and tolerability [154]. - 9MW3011 is currently in multiple Phase Ib clinical studies for treating patients with polycythemia vera, with the first patient enrolled in March 2024 and expected completion in mid-2026 [183]. - 9MW2921, a novel antibody-drug conjugate targeting Trop-2, has received approval for clinical trials in July 2023, focusing on advanced solid tumors, with ongoing I/II phase studies led by Fudan University [187]. - 7MW3711, a novel antibody-drug conjugate targeting B7-H3, is expected to enter the global market with a projected size of $300 million in 2027, growing to $5.5 billion by 2032, reflecting a compound annual growth rate of 74.2% [168].

前十大流通股东累计持有： 6212.33万股，累计占流通股比： 30.43%，较上期变化： 93.85万股。 | 名称 | 持有数量(万股) | 占总股本比 | 增减情况 | | --- | --- | --- | --- | | | | 例(%) | (万股) | | 海南拾玉私募基金管理有限公司-苏州永玉股权投资合伙 | | | | | 企业(有限合伙) | 1310.84 | 6.42 | 不变 | | 深圳市前海中睿鼎盛资产管理有限公司-中睿鼎盛君华1号 | | | | | 私募证券投资基金 | 1024.86 | 5.02 | 不变 | | 汇添富医疗服务灵活配置混合A | 725.61 | 3.55 | 118.63 | | 汇添富达欣混合A | 511.19 | 2.50 | -51.96 | | 工银前沿医疗股票A | 500.00 | 2.45 | -70.01 | | 汇丰晋信智造先锋股票A | 484.12 | 2.37 | 新进 | | 中银创新医疗（002173）混合A | 454.62 | 2.23 | 102.28 | | 鹏华医药科技股票A | 427.86 | 2.10 | ...

Core Insights - The Shanghai Stock Exchange Sci-Tech Innovation Board 100 Index (000698) has shown a positive performance with a 0.61% increase as of March 28, 2025, with notable gains from stocks like Maiwei Bio (688062) up 13.94% and Shenzhou Cell (688520) up 6.51% [1][2] - The upcoming annual performance briefing for the Sci-Tech Innovation Board from April 28 to May 9, 2024, will feature seven "sub-industry dialogue days" focusing on sectors such as AI, robotics, and new energy, aimed at helping investors compare industry dynamics and company advantages [2] - The Sci-Tech 100 Index ETF (588030) has closely tracked the performance of the Sci-Tech Innovation Board 100 Index, with a significant growth in scale of 9.22 billion over the past year [2][3] Performance Metrics - As of March 27, 2025, the Sci-Tech 100 Index ETF has achieved a maximum monthly return of 27.67% since its inception, with the longest consecutive monthly gain being three months and a total increase of 37.87% during that period [2] - The ETF has outperformed its benchmark with an annualized excess return of 0.64% over the past year, while the maximum drawdown this year has been 7.83% [3] - The management fee for the Sci-Tech 100 Index ETF is 0.15%, and the custody fee is 0.05%, making it one of the lowest in its category [3] Top Holdings - As of February 28, 2025, the top ten weighted stocks in the Sci-Tech 100 Index include Sitaiwei (688213), Baiji Shenzhou (688235), and Hengxuan Technology (688608), collectively accounting for 24.45% of the index [3]

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。 证券代码：688062 证券简称：迈威生物 公告编号：2025-008 迈威（上海）生物科技股份有限公司 自愿披露关于与君实生物就阿达木单抗注射液 合作开发协议签订补充协议的公告 重要内容提示： 2025 年 3 月 26 日，迈威（上海）生物科技股份有限公司（以下简称"公司" 或"迈威生物"）、公司全资子公司江苏泰康生物医药有限公司（以下简称"泰 康生物"）、上海君实生物医药科技股份有限公司（以下简称"君实生物"）、 君实生物全资子公司苏州众合生物医药科技有限公司（以下简称"苏州众合"） 签订《关于<重组人源抗 TNF-α 单克隆抗体注射液合作开发协议>之补充协议》 （以下简称"本补充协议"），对君实生物为药品上市许可持有人（Marketing Authorization Holder，以下简称"MAH"）期间的权益分享条款进行重新约定， 现将相关情况公告如下： 1、针对重组人源抗 TNF-α 单克隆抗体注射液（现称"阿达木单抗注射液"， 商品名：君迈康®）的中国大陆区域内 ...