证券代码：688062 证券简称：迈威生物 公告编号：2024-049 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 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。 迈威（上海）生物科技股份有限公司（以下简称"公司"）于 2024 年 10 月 30 日召开第二届董事会第十四次会议、第二届监事会第十三次会议，审议通 过了《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议案》，同意 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，且授权公司管理 层办理此次募集资金专用账户变更并重新签订四方监管协议相关事宜。保荐机构 海通证券股份有限公司（以下简称"海通证券"或"保荐机构"）对该事项出具 了明确同意的核查意见。现将有关情况公告如下： 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 ...

Revenue and Sales Performance - Revenue for the current reporting period increased by 167.73% year-over-year, driven by a 163.22% increase in drug sales revenue to 25.05 million yuan[2][8] - Cumulative revenue from the beginning of the year to the end of the reporting period increased by 41.79%, with drug sales revenue growing 287.12% to 90.715 million yuan[2][8] - Revenue for the first three quarters of 2024 reached 141,095,928.06 RMB, a 41.8% increase compared to 99,511,384.04 RMB in the same period of 2023[21] - Cash received from sales and services in the first three quarters of 2024 was 180,722,393.45 RMB, doubling from 90,276,727.22 RMB in 2023[24] - Cash received from selling goods and providing services was 299.14 million yuan, an increase of 72.97 million yuan compared to the previous period[25] Profit and Loss - Net profit attributable to shareholders for the current reporting period was -249.11 million yuan, with a cumulative net loss of -694.09 million yuan from the beginning of the year[2] - Net loss for the first three quarters of 2024 was 696,015,164.94 RMB, a 2.9% increase from 676,619,021.82 RMB in 2023[22] - Total comprehensive loss for the first three quarters of 2024 was 697,030,853.80 RMB, a 3.8% increase from 671,829,240.37 RMB in 2023[23] - Basic and diluted earnings per share for the first three quarters of 2024 were both -1.74 RMB, compared to -1.68 RMB in 2023[23] R&D Expenses - R&D expenses for the current reporting period amounted to 158.88 million yuan, accounting for 621.42% of revenue, a decrease of 987.81 percentage points year-over-year[3][8] - Cumulative R&D expenses from the beginning of the year to the end of the reporting period were 481.01 million yuan, representing 340.91% of revenue, a decrease of 155.63 percentage points year-over-year[3][8] - R&D expenses for the first three quarters of 2024 were 481,008,266.28 RMB, a slight decrease of 2.6% compared to 494,110,768.85 RMB in 2023[21] Assets and Liabilities - Total assets at the end of the reporting period were 4.50 billion yuan, a slight increase of 0.95% compared to the end of the previous year[3] - Shareholders' equity attributable to the parent company decreased by 25.79% to 1.92 billion yuan compared to the end of the previous year[3] - The company's total liabilities as of September 30, 2024, were 2,592,617,747.89 yuan, with a significant increase in short-term borrowings to 907,717,127.46 yuan[18][19] - The company's total equity as of September 30, 2024, was 1,904,971,009.25 yuan, with a decrease in undistributed profits to -4,445,439,800.10 yuan[19][20] Non-Recurring Gains - Government subsidies contributed 5.19 million yuan to non-recurring gains for the current reporting period, with a cumulative amount of 20.14 million yuan from the beginning of the year[5][6] - Financial asset investment gains and fair value changes contributed 650,412.80 yuan to non-recurring gains for the current reporting period, with a cumulative amount of 2.50 million yuan from the beginning of the year[5][6] Product Pipeline and Clinical Trials - The company has 15 core products in clinical or market stages, including 11 innovative drugs and 4 biosimilars, covering major disease areas such as oncology, immunology, bone diseases, ophthalmology, and hematology[12] - The company's recombinant anti-Nectin-4 antibody-drug conjugate (9MW2821) received FDA Fast Track designation for treating locally advanced or metastatic Nectin-4 positive triple-negative breast cancer[13] - 9MW2821 has been approved by the NMPA to initiate Phase II clinical trials for treating triple-negative breast cancer either as a monotherapy or in combination with PD-1 inhibitors[13] - As of the report date, 9MW2821 has received 3 FDA Fast Track designations and 1 Orphan Drug designation for treating esophageal cancer, cervical cancer, and triple-negative breast cancer[13] - 9MW2821 was included in the CDE's Breakthrough Therapy list for treating locally advanced or metastatic urothelial carcinoma in August 2024[13] - The company initiated 2 Phase III pivotal registration clinical studies for 9MW2821 during the reporting period, targeting cervical cancer and first-line treatment of urothelial carcinoma in combination with PD-1 monoclonal antibody[13] - The company's recombinant human vascular endothelial growth factor receptor-antibody fusion protein (9MW0813) completed Phase III clinical trial head-to-head comparison with the original drug Eylea® in August 2024, with data locked ahead of schedule. The research data is expected to be obtained by the end of 2024, and the market application is planned to be submitted in 2025, potentially becoming one of the top three Eylea® biosimilars in China[14] Marketed Products and Sales - As of the reporting period, the company has three marketed products: Mailishu®, Maijian®, and Junmaikang®. Mailishu® achieved sales revenue of 235.624 million yuan in Q3 2024, with access to 1,336 hospitals and coverage in 2,632 pharmacies[15] - Maijian® achieved sales revenue of 14.876 million yuan in Q3 2024, with access to 42 hospitals and coverage in 653 pharmacies[15] - Junmaikang® has been approved for marketing since March 2022, with access to 270 hospitals and coverage in 1,370 pharmacies[15] - The company signed commercialization agreements for Mailishu® and Maijian® with pharmaceutical companies in Brazil and Jordan in August and September 2024, respectively. For Junmaikang®, agreements were signed with companies in Jordan and Peru in September 2024, covering dozens of overseas markets with a cumulative milestone amount of 14.285 million USD[16] Shareholder Information - The company's largest shareholder, Langrun (Shenzhen) Equity Investment Fund, holds 140,560,000 shares, representing 35.18% of the total shares[9] - The second-largest shareholder, Ningbo Meishan Bonded Port Area Zhongjun Jianlong Investment Partnership, holds 20,000,000 shares, accounting for 5.01% of the total shares[9] - The third-largest shareholder, Liu Datao, holds 15,100,000 shares, representing 3.78% of the total shares[9] - The company's top 10 shareholders include several institutional investors such as China Merchants Bank, China Construction Bank, and China Minsheng Bank, holding shares through various funds[10] Cash Flow - Net cash flow from operating activities was -668.22 million yuan, a decrease of 105.76 million yuan compared to the previous period[25] - Net cash flow from investing activities was -203.17 million yuan, an improvement of 248.53 million yuan compared to the previous period[25] - Net cash flow from financing activities was 827.13 million yuan, an increase of 498.64 million yuan compared to the previous period[26] - Cash paid for goods and services was 21.92 million yuan, a decrease of 35.85 million yuan compared to the previous period[25] - Cash paid to employees was 365.18 million yuan, an increase of 54.74 million yuan compared to the previous period[25] - Cash received from investments was 322.06 million yuan, an increase of 41.22 million yuan compared to the previous period[25] - Cash paid for investments was 290.91 million yuan, an increase of 20.18 million yuan compared to the previous period[25] - Cash received from borrowings was 2.24 billion yuan, an increase of 1.81 billion yuan compared to the previous period[26] - Net increase in cash and cash equivalents was -45.19 million yuan, an improvement of 635.00 million yuan compared to the previous period[26] Operating Costs and Expenses - Operating costs for the first three quarters of 2024 were 844,467,620.30 RMB, up 8.9% from 775,388,223.53 RMB in 2023[21] - Sales expenses for the first three quarters of 2024 were 168,466,717.93 RMB, a 4.5% increase from 161,278,252.49 RMB in 2023[21] - Management expenses for the first three quarters of 2024 were 158,902,611.01 RMB, up 10.2% from 144,203,638.77 RMB in 2023[21] - Financial expenses for the first three quarters of 2024 were 22,740,778.95 RMB, compared to a financial income of 26,622,479.36 RMB in 2023[21] Monetary Funds and Financial Position - As of September 30, 2024, the company's monetary funds amounted to 1,564,341,685.47 yuan, with total assets of 4,497,588,757.14 yuan[17][18][19][20]

Group 1: Clinical Progress and Data - The Nectin-4 ADC project (referred to as "282") has shown significant clinical progress, with over 400 patients enrolled under the target dose, demonstrating outstanding anti-tumor activity and good safety [6][12]. - In the context of Urothelial Carcinoma (UC), the project reported an Objective Response Rate (ORR) of 62.2%, a median Progression-Free Survival (mPFS) of 8.8 months, and a median Overall Survival (mOS) of 14.2 months [6][12]. - For Cervical Cancer (CC), the project reported an ORR of 35.8% and a mPFS of 3.9 months, with ongoing clinical studies for both second-line and first-line treatments [7][12]. Group 2: Regulatory Milestones - The project "282" has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) in August 2024 [6][12]. - The project has received multiple designations from the FDA, including Fast Track Designation (FTD) and Orphan Drug Designation (ODD) for various indications, indicating a strong regulatory recognition [8][12]. Group 3: Market and Competitive Landscape - The approval of Padcev in China is expected to impact all drugs in the Urothelial Carcinoma space, prompting the company to actively respond to market competition [10][12]. - The long-acting white blood cell booster drug 8MW0511 is projected to reach a market scale of CNY 10.27 billion by 2025, with optimistic market prospects [14][12]. Group 4: Financial Health and R&D Strategy - As of June 30, 2024, the company reported cash and cash equivalents of CNY 1.737 billion, indicating a solid financial position [18][12]. - The company plans to focus its R&D investments on molecules with global competitive advantages and aims to find partners for global clinical and commercial capabilities [18][12].

证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： -16% -3% 9% 21% 33% 46% 23-0923-1023-1123-1224-0124-0224-0324-0424-0524-0724-0824-09 迈威生物 沪深300 首次覆盖报告 2024 年 9 月 21 日 迈威生物-U (688062.SH) 买入（首次覆盖） ——ADC 核心管线进展积极，商业化稳步推进 投资要点： ➢ 公司 2024 半年报成果显著：迈威生物 2024 年中报业绩显示，上半年公司实现营业收入 1.16 亿元，同比增长 28.42%。其中药品销售收入为 6566.5 万元，较上年同期 1391.65 万元增长 371.85%。同时 9MW3011 项目与美国 DISC MEDICINE, INC.独家许可协议于本期确认技术 授权收入较多。公司 2024 年上半年研发投入为 3.22 亿元，同比降低 5.38%；销售费用 1.13 亿元，同比增长 29.82%，公司商业化不断推进，呈现良好态势。 ➢ 核心管线 Nectin-4 ...

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].