迈威（上海）生物科技股份有限公司 2024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 2024 年度"提质增效重回报"行动方案。具体方案如下： 量的 9MW1911 后，安全且耐受性良好。目前正在开展慢性阻塞性肺疾病（COPD） 适应症 Ib/IIa 期临床试验。另一款靶向人白介素-11（IL-11）的单抗（9MW3811） 全球进展处于第一梯队，也是国内首个进入临床的药物，主要应用于肺纤维化疾 病（IPF）等领域，市场前景广阔，现已在中国、澳大利亚和美国获批进入临床阶 段，目前已完成中澳 I期临床研究。此外，靶向 TMPRSS6单抗（9MW3011）研发 进展亦处于全球第一梯队，针对 β-地中海贫血、真性红细胞增多症等与铁稳态相 关的疾病，展现出较大治疗潜力，已先后获得美国食品药品监督管理局的快速通 道认定（FTD）和孤儿药认定 ...

Research and Development - The company invested significant funds in R&D, with expenses of CNY 622.51 million in 2021, CNY 758.61 million in 2022, CNY 835.78 million in 2023, and CNY 322.12 million in the first half of 2024[2]. - The company has 12 core products in the pipeline, requiring ongoing substantial R&D investment for preclinical research, clinical trials, and new drug market preparation[2]. - The R&D of innovative drugs is characterized by long cycles and high costs, with a typical new drug taking around ten years from development to approval[5]. - The company emphasizes the importance of risk-benefit assessment throughout the drug lifecycle, as outlined in recent regulatory guidelines[6]. - The company's R&D expenditure accounted for 278.83% of operating revenue, a decrease of 99.59 percentage points compared to the previous year[23]. - The company has established four technology platforms for drug discovery and development, resulting in 15 new varieties, 3 domestic marketing approvals, and 30 clinical trial approvals since its inception[42]. - The company has filed 47 new invention patent applications from January 1, 2024, to June 30, 2024, bringing the total to 434 applications and 76 granted patents[42]. - The company has completed clinical trial sample preparation for 9 research products and commercial production for 2 products, with a total of 102 batches of raw liquid produced[44]. - The company is committed to driving new product development through innovative technology platforms and exploring drug mechanisms[51]. - 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[101]. Financial Performance - The company's revenue for the first half of 2024 was approximately ¥115.53 million, representing a 28.42% increase compared to ¥89.96 million in the same period last year[22]. - The net profit attributable to shareholders of the listed company was a loss of ¥444.98 million, compared to a loss of ¥413.53 million in the previous year[22]. - The net cash flow from operating activities was a negative ¥461.62 million, compared to a negative ¥321.35 million in the same period last year[22]. - The net assets attributable to shareholders of the listed company decreased by 16.09% to ¥2.17 billion from ¥2.58 billion at the end of the previous year[22]. - Total assets increased by 2.39% to ¥4.56 billion from ¥4.45 billion at the end of the previous year[22]. - The company's operating revenue for the reporting period increased by 25.57 million yuan, a year-on-year growth of 28.42%, primarily driven by pharmaceutical sales revenue of 65.67 million yuan, which grew by 371.85% compared to 13.92 million yuan in the same period last year[23]. - The net loss attributable to shareholders increased by 31.46 million yuan compared to the same period last year, mainly due to significant investments in clinical trials for ongoing projects and increased commercialization-related expenses[24]. - The net cash outflow from operating activities increased by 140.28 million yuan compared to the same period last year, primarily due to the refund of research settlement funds to Shengsen Bio[25]. - The company reported a total R&D investment of ¥322,124,870.91, a decrease of 5.38% compared to the previous year[129]. - The company reported a net loss attributable to shareholders of 444.98 million yuan, with a net loss of 460.73 million yuan after excluding non-recurring gains and losses, primarily due to increased expenditures for clinical trials and commercialization efforts[156]. Market and Product Development - The company is focusing on the development of innovative drugs guided by clinical value, aligning with national policies to enhance the biopharmaceutical industry[28]. - The company is actively involved in the development of antibody-drug conjugates, with products like 9MW2821 and 9MW2921 targeting Nectin-4 and Trop-2, respectively[13]. - The company has developed multiple monoclonal antibody injection products, including 9MW0113, a fully human anti-TNF-α monoclonal antibody injection, and 9MW0311, a fully human anti-RANKL monoclonal antibody injection[13]. - The company is exploring market expansion opportunities through strategic partnerships and collaborations with other biotech firms[12]. - The company has confirmed significant technical authorization income from the 9MW3011 project under a licensing agreement with DISC MEDICINE, INC.[23]. - The company is actively pursuing additional indications for 9MW0321 and has established partnerships for its commercialization in multiple countries[61]. - The company has signed formal cooperation agreements for the product 9MW0311 with a Brazilian pharmaceutical company, which will be responsible for product registration and commercialization in Brazil[143]. - The company aims to leverage its existing business network in emerging markets to achieve rapid product launches, particularly in countries along the "Belt and Road" initiative[51]. - The company is committed to accelerating the overseas business expansion and registration process, utilizing its extensive commercial resources and international registration capabilities[144]. - The company has established a strong overseas business development capability and rich registration experience, focusing on emerging markets along the "Belt and Road" initiative[143]. Regulatory and Compliance - The domestic production registration application for the self-developed product 8MW0511 was accepted by the National Medical Products Administration in December 2023, with potential impacts on sales revenue if it fails to pass approval[3]. - The company is committed to adhering to Current Good Manufacturing Practice (cGMP) standards to ensure quality in production processes[13]. - The company has established a drug safety committee to manage major risks and drug safety events[124]. - The company has implemented a drug safety quality management system to ensure compliance with relevant laws and regulations[124]. - The company has set up multiple channels to collect adverse drug reaction reports from healthcare professionals and patients[124]. Market Trends and Competitive Landscape - The Chinese pharmaceutical market is projected to reach 1.828 trillion yuan in 2024, with a compound annual growth rate of approximately 6.0% from 2025 to 2030[27]. - The biopharmaceutical market in China is expected to grow to 587.1 billion yuan in 2024 and 1.1491 trillion yuan by 2030, with a compound annual growth rate of about 11.2% from 2025 to 2030[27]. - Recent government policies aim to improve the payment environment for innovative drugs, which is expected to stabilize market expectations and support long-term growth in the biopharmaceutical sector[29]. - The global market for long-acting G-CSF is projected to reach ¥10.27 billion by 2025 and ¥13.54 billion by 2030, indicating a positive market outlook[31]. - The global autoimmune disease drug market is expected to reach $141.9 billion by 2024, with a compound annual growth rate (CAGR) of 3.68% from 2023 to 2030[32]. - The Chinese autoimmune disease drug market is projected to grow to $6.1 billion by 2024, with a CAGR of 27.3% from 2021 to 2025[32]. - The company’s adalimumab biosimilars are gaining market share due to their price advantages, with a projected market share increase[34]. - The company is focusing on addressing the increasing osteoporosis prevalence due to aging demographics in China[36]. - The company is enhancing its marketing system to address the low usage rates of biopharmaceuticals in various treatment areas, amidst increasing competition from domestic innovative drug companies[46]. Production and Operational Capacity - The company has established a production capacity of 8,000L for antibody drugs and 4,000L for recombinant protein drugs at its Taizhou production base, with a total of 102 batches of raw material production completed[137]. - The Shanghai Jinshan production base is advancing a project for an annual production capacity of 1,000kg of antibodies, with 50,637 square meters of construction completed[137]. - The ADC pilot industrialization project has completed the construction of the first phase, with 4 batches of ADC raw material production and 5 batches of formulation production successfully prepared[138]. - The Taizhou production base has completed trial production of ADC drugs, producing 4 batches of ADC raw liquid and 5 batches of formulations, all of which passed quality inspection, marking a key step in the full industrial chain layout for ADC drugs[45]. - The company has completed the installation and validation of two raw material production lines and one vial formulation production line at the Shanghai Jinshan production base, with trial production underway[123]. Environmental and Social Responsibility - The company invested 586,600 CNY in environmental protection during the reporting period[194]. - The total wastewater discharge during the reporting period was 6,073 tons, with all monitoring indicators within normal ranges and below regulatory limits[198]. - The total air emissions during the reporting period reached 13.5 million cubic meters, all meeting the required standards[198]. - The company processed 34.0 tons of hazardous solid waste and 3.4 tons of waste liquid during the reporting period[198]. - The company has established a dedicated environmental health and safety management department to oversee pollution control and compliance with regulations[199].

迈威（上海）生物科技股份有限公司 第二届监事会第十二次会议决议公告 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 十二次会议通知于 2024 年 8 月 20 日以书面方式送达全体监事，于 2024 年 8 月 30 日以现场结合通讯表决方式召开。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 年半年度报告>及摘要的议案》 经审议，全体监事认为公司编制的《2024 年半年度报告》及摘要符合相关法 律法规、中国证监会及上海证券交易所的有关规定，并真实反映了公司 2024 年 半年度的实际经营情况。 证券代码：688062 证券简称：迈威生物 公告编号：2024-045 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。 经审议，全体监事认为公司 2 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-044 迈威（上海）生物科技股份有限公司 关于 2024 年半年度募集资金存放与 实际使用情况的专项报告 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。 根据中国证券监督管理委员会《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》《上海证券交易所科创板股票上市规则》《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》的相关规定， 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"）董 事会就 2024 年半年度（以下简称"本报告期"）募集资金存放与实际使用情况 作如下专项报告： 一、募集资金基本情况 （一）实际募集资金的金额及到账时间 根据中国证券监督管理委员会于 2021 年 12 月 7 日出具的《关于同意迈威 （上海）生物科技股份有限公司首次公开发行股票注册的批复》（证监许可 [2021]3859 号），公司获准向社会公开发行人民币普通股（A 股）99,900,000 股， 发行价格为每股人民币 34. ...

迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会会议资料 2024 年 9 月 | 2024 | 年第三次临时股东大会会议须知 2 | | --- | --- | | 2024 | 年第三次临时股东大会会议议程 4 | | 2024 | 年第三次临时股东大会会议议案 6 | | 议案一、关于调增 | 2024 年度向金融机构申请授信及融资额度的议案 6 | 迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会会议须知 为了维护全体股东的合法权益，保证股东在迈威（上海）生物科技股份有限 公司（以下简称"公司"）依法行使股东权利，确保 2024 年第三次临时股东大 会会议的正常秩序和议事效率，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（以下简称"中国证监会"）《上市公司股东大会规则》以及《迈 威（上海）生物科技股份有限公司公司章程》（以下简称"《公司章程》"）《迈 威（上海）生物科技股份有限公司股东大会议事规则》等有关规定，特制定本须 知，请全体出席股东大会的人员自觉遵守。 一、 为确认出席大会的 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-042 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW2821 联合 PD-1 单抗一线治疗 尿路上皮癌的Ⅲ期临床研究 获得 CDE 同意的公告 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： 9MW2821 是迈威（上海）生物科技股份有限公司（以下简称"迈威生物" 或"公司"）自主研发的创新药，公司已经向国家药品监督管理局药品审评中心 （以下简称"CDE"）递交了关于"一项评估 9MW2821 联合特瑞普利单抗对比 标准化疗一线治疗局部晚期或转移性尿路上皮癌患者的随机、对照、开放、多中 心Ⅲ期临床研究"的方案并获得同意，公司已启动 9MW2821 联合 PD-1 单抗一 线治疗尿路上皮癌的Ⅲ期临床研究，目前处于入组阶段。现将相关情况公告如下： 一、药品基本情况 药品名称：9MW2821 剂型：注射剂 注册分类：治疗用生物制品 1 类 适应症：尿路上皮癌 二、药品的其他相关情况 9MW2821 为迈威生物靶向 Nectin-4 的定点偶 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-041 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW2821 治疗宫颈癌 的Ⅲ期临床研究获得 CDE 同意的公告 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： 9MW2821 是迈威（上海）生物科技股份有限公司（以下简称"迈威生物" 或"公司"）自主研发的创新药，公司已经向国家药品监督管理局药品审评中心 （以下简称"CDE"）递交了关于"9MW2821 对比研究者选择的化疗治疗含铂 化疗失败的复发或转移性宫颈癌的随机、开放、对照、多中心Ⅲ期临床研究"的 方案并获得同意。公司即将启动 9MW2821 治疗含铂化疗失败的复发或转移性宫 颈癌的Ⅲ期临床研究。现将相关情况公告如下： 一、药品基本情况 药品名称：9MW2821 剂型：注射剂 注册分类：治疗用生物制品 1 类 适应症：宫颈癌 二、药品的其他相关情况 9MW2821 为迈威生物靶向 Nectin-4 的定点偶联 ADC 新药，为公司利用 ADC 药物开发平台开发的创新品种，通过具 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-040 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW2821 用于尿路上皮癌适应症 纳入突破性治疗品种的公告 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。 1 的 ADC 偶联工艺，实现抗体的定点修饰。9MW2821 注射入体内后，可与肿瘤 细胞表面的 Nectin-4 结合并进入细胞，通过酶解作用，定向释放细胞毒素，从而 实现对肿瘤的精准杀伤。公司目前正在针对尿路上皮癌、宫颈癌、食管癌、乳腺 癌等多个适应症开展多项临床研究，截至目前，已有超过 350 例受试者入组，现 有临床研究结果显示了突出的治疗有效性与安全性。 9MW2821 是国内同靶点药物中首个开展临床试验的品种，亦是全球同靶点 药物中首个在宫颈癌、食管癌以及乳腺癌适应症披露临床有效性数据的品种。 9MW2821 于 2024 年获得美国食品药品监督管理局（FDA）授予的多项审评资质： "快速通道认定"（FTD）分别用于治疗晚期、复发或转移性食管鳞癌（ESCC）， 既往接受过含铂化疗方案 ...

海通证券股份有限公司 关于迈威（上海）生物科技股份有限公司 变更部分募集资金专用账户并重新签订四方监管协议事项 的核查意见 海通证券股份有限公司（以下简称"海通证券"或"保荐机构"）作为迈威 （上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"）首次公开 发行股票并上市持续督导保荐机构，根据《证券发行上市保荐业务管理办法》《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》《上海证 券交易所科创板股票上市规则》《上海证券交易所上市公司自律监管指引第 11 号 ——持续督导》《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，对迈威生物变更部分募集资金专用账户并重新签订四方监管 协议事项进行了核查，具体情况如下： 一、募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迈威（上海）生物科技股份 有限公司首次公开发行股票注册的批复》（证监许可〔2021〕3859 号），公司首 次向社会公开发行人民币普通股 99,900,000 股，每股发行价格为人民币 34.80 元， 募集资金总额为人民币 3,476,520,000.00 元，募集资金净额为人民币 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-036 经审议，全体监事认为公司本次变更部分募集资金专用账户并重新签订四方 监管协议的事项符合公司的实际情况及经营管理需要，有利于加强募集资金管理 效率，不存在变相改变募集资金用途的情况，不存在损害公司及其他股东合法权 益的情形。上述事项的内容和审议均符合《上海证券交易所科创板股票上市规则》 《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》《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》等法律法规、 规范性文件以及《公司章程》的相关规定，程序合法有效。因此，监事会同意上 述事项。 具体内容详见公司同日在上海证券交易所网站（www.sse.com.cn）和指定媒 体披露的《迈威（上海）生物科技股份有限公司关于变更部分募集资金专用账户 并重新签订四方监管协议的公告》。 表决结果：3 票同意，0 票反对，0 票弃权。 （二）审议通过《关于调增2024年度向金融机构申请授信及融资额度的议案》 迈威（上海）生物科技股份有限公司 第二届监事会第十一次会议决议公告 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 ...