证券代码：688062 证券简称：迈威生物 公告编号：2024-053 迈威（上海）生物科技股份有限公司 关于制定、修订 H 股发行后适用的《公司章程》及公 司部分治理制度的公告 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 12 月 15 日召开第二届董事会第十五次会议，审议通过了《关于制定 H 股发行后适用的 <公司章程>的议案》《关于制定 H 股发行后适用的<股东会议事规则>的议案》《关 于制定 H 股发行后适用的<董事会议事规则>的议案》等议案，并于同日召开第二 届监事会第十四次会议，审议通过了《关于制定 H 股发行后适用的<监事会议事 规则>的议案》。上述部分议案尚需提请公司 2024 年第四次临时股东大会审议。现 将具体情况公告如下： 一、制定《公司章程》（草案）情况 基于公司在境外发行股份（H 股）并在香港联合交易所有限公司主板上市 （以下简称"本次发行 H 股并上市"）需要，根据《中华人民共和国公司法》《境 内企业境外发行证券和上市管理 ...

Group 1: Company Overview and Investor Relations - The company is named Maiwei (Shanghai) Biotechnology Co., Ltd., with the stock code 688062 [1] - The investor relations activity record indicates various types of engagement, including analyst meetings and media interviews [2][4] Group 2: Clinical Development and Pipeline - The company is advancing its BD (Business Development) efforts, particularly with the Nectin-4 ADC (MW282), which has expanded its potential collaboration areas from urological tumors to gastrointestinal, gynecological, and breast cancer [4][6] - As of 2024, the Nectin-4 ADC has progressed in clinical trials for multiple indications, including: - Urothelial carcinoma (UC): Currently in Phase III trials with rapid enrollment [6] - Cervical cancer (CC): First in the world to enter Phase III trials for this target [6] - Esophageal cancer (EC): Phase II trials ongoing, with FDA orphan drug designation [6] - Triple-negative breast cancer (TNBC): Phase II trials initiated [6] Group 3: Market Potential and Growth Opportunities - The company anticipates significant growth potential in the domestic and international BD opportunities due to its innovative pipeline [5][6] - The ST2 monoclonal antibody (9MW1911) is the first of its kind in clinical research in China, currently in Phase I/II trials for chronic obstructive pulmonary disease (COPD) [9][10] - The prevalence of COPD in China is rising, with a reported rate of 13.7% among individuals over 40 years old [10] Group 4: Financial Performance and Commercialization - The sales revenue for the company's Dizu single antibody reached CNY 90.715 million in the first three quarters, a year-on-year increase of 287.1% [18] - The long-acting white blood cell booster (8MW0511) is expected to reach a market size of CNY 10.27 billion by 2025, with optimistic growth projections [16] - The company has signed cooperation agreements for product registration and commercialization in several emerging markets, including countries along the Belt and Road Initiative [18][20]

迈威（上海）生物科技股份有限公司 证券代码：688062 证券简称：迈威生物 公告编号：2024-051 迈威（上海）生物科技股份有限公司 关于召开 2024 年半年度暨第三季度 业绩说明会的公告 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"）已于 2024 年 8 月 31 日、2024 年 10 月 31 日在上海证券交易所网站（www.sse.com.cn）披露了《2024 年半年度报告》《2024 年半年度报告摘要》及《2024 年第三季度报告》。为便 于广大投资者更加全面深入地了解公司经营业绩、发展战略等情况，公司定于 会议召开时间：2024 年 11 月 29 日（星期五）10:00-11:00 会议召开地点：价值在线（www.ir-online.cn） 会议召开方式：网络互动方式 会 议 问 题 征 集 ： 投 资 者 可 于 2024 年 11 月 29 日前访问网址 https://eseb.cn/1jA0rqu7C5a 或使用微信扫描下方小程序码进行会前 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [4] Core Insights - The company reported a revenue of 141 million yuan for Q3 2024, representing a year-on-year growth of 41.79%, with a quarterly revenue of 25.57 million yuan, showing a significant increase of 167.73% [2][6] - The company has three commercialized products, with sales from Mai Li Shu reaching 23.56 million yuan in Q3, and Mai Wei Jian generating 1.49 million yuan in the same period [6] - The company has initiated two Phase III clinical trials for 9MW2821 in Q3, targeting cervical cancer and first-line treatment for urothelial carcinoma [6] Summary by Sections Financial Performance - Revenue for 2024 is projected to be 220 million yuan, with a growth rate of 72.49% [7] - The company expects revenues of 1.09 billion yuan in 2025 and 2.27 billion yuan in 2026, with growth rates of 396.15% and 107.68% respectively [7] - Net profit is forecasted to be -849 million yuan in 2024, improving to -199 million yuan by 2026 [7] Product Development - The company has three listed products, with Mai Li Shu and Mai Wei Jian showing significant market penetration across multiple provinces and hospitals [6] - The clinical pipeline includes G-CSF in NDA stage, and other ophthalmic drugs in Phase III trials [6] Market Position - The company has established a presence in 30 provinces with 1,336 hospitals and 2,632 pharmacies for Mai Li Shu, and 25 provinces with 42 hospitals and 653 pharmacies for Mai Wei Jian [6]

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 ...

经审议，全体监事认为公司编制的《2024 年第三季度报告》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 年第三 季度的实际经营情况。 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 2024 年第三季度报告》。 表决结果：3 票同意，0 票反对，0 票弃权。 （二）审议通过《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》 证券代码：688062 证券简称：迈威生物 公告编号：2024-050 迈威（上海）生物科技股份有限公司 第二届监事会第十三次会议决议公告 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 十三次会议通知于 2024 年 10 月 25 日以书面方式送达全体监事，于 2024 年 10 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 ...

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]

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 ...

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 ...