证券代码：688062 证券简称：迈威生物 公告编号：2024-047 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 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：上海市浦东新区李冰路 576 号创想园 3 号楼 103 会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 131 | | --- | --- | | 普通股股东人数 | 131 | | 2、出席会议的股东所持有的表决权数量 | 209,329,431 | | 普通股股东所持有表决权数量 | 209,329,431 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的 | 52.3847 | | 比例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例 | 5 ...

北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会的 法律意见书 植德沪(会)字[2024]0041 号 致：迈威（上海）生物科技股份有限公司（迈威生物/贵公司） 北京植德（上海）律师事务所（以下简称"本所"）接受贵公司的委托，指 派律师出席并见证贵公司 2024 年第三次临时股东大会（以下简称"本次会议"）。 二〇二四年九月 上海市徐汇区虹桥路 183 号徐家汇中心三期 A 座办公楼 27 层（THREE itc） 邮编：200030 27 th Floor Tower A, THREE itc, No.183 Hongqiao Road, Xuhui District, Shanghai 200030 P.R.C 电话(Tel)：021-52533500 传真(Fax)：021-52533599 www.meritsandtree.com 北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会的法律意见书 植德沪（会）字[2024]0041 号 本所律师参加本次会议进行见证，并根据《中华人民共和国公司法》（以下 简称" ...

Investment Rating - The investment rating for the company is "Outperform the Market" [1][3][11] Core Insights - The core product 9MW2821, a Nectin-4 ADC, is rapidly advancing in clinical trials for multiple indications, including entering Phase 3 registration trials for urothelial carcinoma (UC) and cervical cancer (CC) [1][11] - The company is also progressing with its pipeline products, including ST2 monoclonal antibody 9MW1911 in Phase 2 trials for COPD, and other ADCs in early clinical stages [1][11] - The commercialization of biosimilars is proceeding smoothly, with a reported sales increase of 28.4% in the first half of the year, driven by a significant rise in drug sales revenue [1][5] Financial Forecast and Metrics - Revenue projections for 2024-2026 are estimated at 4.17 billion, 8.87 billion, and 14.31 billion yuan, representing year-on-year growth rates of 226%, 113%, and 61% respectively [1][13] - The net profit forecast for the same period is expected to be -749 million, -516 million, and -126 million yuan [1][13] - The company reported a net loss of 4.45 billion yuan in the first half of the year, with R&D expenses of 3.22 billion yuan [1][5][13]

Investment Rating - Maintains "Outperform" rating [1][3] Core Views - The core product 9MW2821, a Nectin-4 ADC, is advancing rapidly in multiple indications, including urothelial carcinoma (UC) and cervical cancer (CC), with Phase 3 registration trials underway [1] - 9MW2821 is also being tested in esophageal cancer (EC) and breast cancer (BC), with clinical data disclosed for CC, EC, and TNBC, aiming to compete with PADCEV through differentiated indications [1] - The company plans to conduct overseas clinical trials for 9MW2821, leveraging comprehensive domestic clinical data to potentially expand into international markets through licensing [1] - The ST2 monoclonal antibody 9MW1911 is in Phase 2 trials for COPD, leading among domestic companies [1] - Other pipeline products, including 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC), are in Phase 1/2 trials, while 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] - The company has demonstrated strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1] Financial Performance - H1 sales reached RMB 116 million (+28.4%), driven by drug sales of RMB 66 million (+371.9%) and significant technology licensing income from the 9MW3011 project [5] - H1 net loss was RMB 445 million (+7.6%), with R&D expenses of RMB 322 million (-5.4%), sales expenses of RMB 113 million (+29.8%), and administrative expenses of RMB 112 million (+18.3%) [5] - Shipments of Maikang exceeded 20,000 units, while Maikang and Maijian completed commercial shipments [5] Revenue and Profit Forecast - Revenue for 2024-26 is projected to be RMB 417 million, RMB 887 million, and RMB 1.431 billion, representing year-on-year growth of 226%, 113%, and 61%, respectively [1] - Net profit attributable to shareholders for 2024-26 is forecasted to be RMB -749 million, RMB -516 million, and RMB -126 million, respectively [1] Pipeline Progress - 9MW1911 (ST2 monoclonal antibody) is in Phase 2 trials for COPD [1] - 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC) are in Phase 1/2 trials [1] - 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] Commercialization - The company has shown strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1]

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 2024 年度持续督导半年度跟踪报告 | 保荐机构名称：海通证券股份有限公司 | 被保荐公司简称：迈威生物 | | --- | --- | | 保荐代表人姓名：王永杰、陈新军 | 被保荐公司代码：688062 | 重大事项提示 截至 2024 年 6 月末，尽管公司已有三款产品陆续获批上市并推进至商业化 阶段，但公司尚未盈利且存在累计未弥补亏损，主要原因是君迈康®、迈利舒®、 迈卫健®上市时间较短，且公司作为一家创新型生物医药企业，成立以来一直保 持较高的研发投入。截至本报告披露日，公司拥有 15 个处于临床或上市阶段的 关键品种，包括 11 个创新药，4 个生物类似药，覆盖肿瘤、免疫、骨疾病、眼 科、血液等多个重大疾病治疗领域。其中，已上市品种 3 个，处于上市许可审评 阶段品种 1 个，处于 III 期关键注册临床阶段品种 3 个，处于其他不同临床阶段 品种 8 个。2024 年 1-6 月，公司研发投入为 32,212.49 万元。 公司未来几年将存在累计未弥补亏损及持续亏损，并将面临如下潜在风险： 公司虽有药品获批上市，但销售收入可能无法弥补 ...

Investment Rating - The report maintains an "Accumulate" rating for the company with a target price of 30.27 CNY, reflecting a potential upside from the current price of 23.1 CNY [3][5]. Core Insights - The company's sales revenue has significantly increased, achieving 116 million CNY in the first half of 2024, a year-on-year growth of 28.42%. The pharmaceutical sales revenue reached 65.67 million CNY, a remarkable increase of 371.85% due to the shipment of 116,994 units of the drug Mai Li Shu and the addition of 487 new hospitals [1][2]. - The Nectin-4 ADC clinical trials are progressing rapidly across multiple indications, with several Phase III trials initiated for various cancers, including urothelial carcinoma and cervical cancer, marking significant advancements in the company's pipeline [1][2]. - The company is actively introducing new products and has established a multi-tier pipeline, including a long-acting G-CSF that has submitted an NDA and is expected to be approved in 2025, and a biosimilar of Abicipar that has completed Phase III trials [1][2]. Financial Summary - The company reported a net profit attributable to the parent company of -444.5 million CNY for the first half of 2024, a decrease of 7.61% year-on-year. The forecast for net profit for 2024-2026 has been adjusted to -1.138 billion CNY, -918 million CNY, and -559 million CNY respectively [1][2]. - The projected revenue for 2024 is 310 million CNY, with a year-on-year growth of 142.8%, and is expected to reach 1.576 billion CNY by 2026 [2][8]. - The company's reasonable market value is estimated at 12.094 billion CNY, corresponding to a target price of 30.27 CNY per share [6][7].

迈利舒放量显著，Nectin-4 ADC 进展迅速 ——迈威生物 2024 年中报点评 核心观点 ⚫ 迈利舒迅速放量，药品销售收入大幅增长。公司发布 24 年中报，实现营业收入 1.16 亿元（同比+28.42%），归母净利润-4.45 亿元（同比-7.61%），扣非归母净 利润-4.61 亿元（同比-10.88%）。其中药品销售收入 6,566.50 万元（同比 +371.85%），主要系迈利舒新增发货 116,994 支，新增准入医院 487 家，上半年销 售已超 23 年全年。 ⚫ Nectin-4 ADC 临床进展迅速，多适应症全面铺开。公司 Nectin-4 ADC 今年以来披 露了多个适应症的积极数据，24 年上半年已在多瘤种中迅速推进多项临床试验： 1）尿路上皮癌：启动联用 PD-1 抑制剂一线治疗的 III 期临床试验；2）宫颈癌：启 动单药二/三线治疗的 III 期临床试验（全球首个在该适应症进入 III 期的同靶点药 物），联用 PD-1 抑制剂一线治疗的 IND 获受理；3）三阴性乳腺癌：启动联用 PD1 抑制剂一线治疗或单药二线治疗的 II 期临床试验；4）食管癌：联用 PD-1 抑制 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [4] Core Insights - The company reported a revenue of 116 million yuan for the first half of 2024, representing a year-over-year increase of 28.42%. However, the net profit attributable to shareholders was -445 million yuan, and the net profit after deducting non-recurring items was -461 million yuan [2][6] - The development of ADC (Antibody-Drug Conjugate) is progressing steadily, with multiple Phase III clinical trials initiated for the drug 9MW2821, which has received several FDA designations, including orphan drug status for esophageal cancer and fast track designation for cervical cancer and triple-negative breast cancer [6] - Sales are increasing significantly, with G-CSF expected to be approved for market by 2025. In the first half of 2024, drug sales revenue reached 65.67 million yuan, a year-over-year increase of 371.85% [6] Financial Performance and Projections - The company expects revenues for 2024, 2025, and 2026 to be 714 million yuan, 1.704 billion yuan, and 2.967 billion yuan, respectively, with year-over-year growth rates of 458.42%, 138.64%, and 74.14% [6] - The projected net profits for the same years are -1.025 billion yuan, -888 million yuan, and -539 million yuan, with growth rates of 2.70%, 13.38%, and 39.33% respectively [6] - The earnings per share (EPS) are forecasted to be -2.57 yuan, -2.22 yuan, and -1.35 yuan for 2024, 2025, and 2026 [6] Market Position and Valuation - The current price of the stock is 22.19 yuan, with a market capitalization of approximately 4.53 billion yuan [4] - The company has a total share capital of 399.60 million shares, with 204.17 million shares in circulation [4] - The price-to-earnings (P/E) ratio is projected to be -8.7 for 2024, -10.0 for 2025, and -16.5 for 2026, indicating a negative earnings outlook [6]

Investment Rating - The investment rating for the company is "Buy - A" with a target price of 37.87 CNY for the next six months [3][5]. Core Insights - The company reported a revenue of 116 million CNY for the first half of 2024, representing a year-on-year growth of 28.42%. However, it incurred a net loss of 445 million CNY during the same period [1]. - The NECTIN-4 ADC clinical program is progressing rapidly, with three Phase 3 clinical trials currently underway, targeting various types of cancer [1]. - The long-acting white blood cell enhancer is expected to be approved for market launch in 2025, with the company having submitted its application in December 2023 [1]. - The company has a robust pipeline of innovative drugs, including B7H3 ADC and TROP2 ADC, which are advancing through clinical trials [1]. Financial Projections - Revenue projections for the company are estimated at 300 million CNY in 2024, 1.11 billion CNY in 2025, and 2.01 billion CNY in 2026, with net losses expected to decrease from 920 million CNY in 2024 to 87 million CNY in 2026 [2][6]. - The company anticipates significant revenue growth driven by the launch of its existing and upcoming products [2][6]. Market Performance - The company's stock price as of August 30, 2024, was 22.19 CNY, with a market capitalization of approximately 8.87 billion CNY [3]. - The stock has shown a 12-month price range between 20.0 CNY and 36.5 CNY [3]. Clinical Development - The NECTIN-4 ADC has received multiple designations from the FDA, including Fast Track Designation and Orphan Drug Designation, indicating its potential in treating specific cancer types [1]. - The company is leveraging its next-generation ADC technology, which is expected to enhance the efficacy and safety of its drug candidates [1].

一、 召开会议的基本情况 （一） 股东大会类型和届次 2024 年第三次临时股东大会 证券代码：688062 证券简称：迈威生物 公告编号：2024-046 迈威（上海）生物技术股份有限公司 关于召开 2024 年第三次临时股东大会的通知 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： 召开日期时间：2024 年 9 月 19 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 2024 年 9 月 19 日 至 2024 年 9 月 19 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：2024年9月19日 本次股东大会采用的网络投 ...