证券代码：688062 证券简称：迈威生物 公告编号：2025-042 迈威（上海）生物科技股份有限公司 自愿披露关于注射用 7MW4911 临床试验申请 获得 FDA 许可的公告 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。 二、药品的其他相关情况 7MW4911 是基于公司自主知识产权的 IDDC™抗体偶联技术平台开发的靶向 钙黏蛋白 17（CDH17）的创新抗体偶联药物（ADC）。CDH17 作为经泛癌种多组 学验证的潜力治疗靶点，在正常组织中局限于肠上皮基底外侧膜表达，而在结直 肠癌、胃癌及胰腺癌等消化道恶性肿瘤中呈现显著过表达，其异常高表达与肿瘤 侵袭转移及不良预后密切相关，为精准干预提供了理想靶点。 1 7MW4911 采用高度工程化设计，整合三大核心元件：具有快速内化特性及跨 物种（人/猴）中等亲和力的 CDH17 高特异性单抗 Mab0727、新型可裂解连接子、 以及为克服多药耐药机制设计的专有 DNA 拓扑异构酶 I 抑制剂 MF-6 载荷。MF-6 通过卓越的血浆稳定性、可控的药物释放及强效旁观者效应 ...

Group 1 - The core point of the article is that Maiwei Biotech (688062.SH) has received a Clinical Study Continuation Notification from the FDA, allowing the clinical trial application for the injectable 7MW4911 to proceed [1] - The clinical trial will focus on the safety, pharmacokinetics, and efficacy of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors [1]

近日，迈威（上海）生物科技股份有限公司收到美国食品药品监督管理局（FDA）签发的《临床研究继 续进行通知书》，注射用7MW4911临床试验申请正式获FDA许可。该药品是基于公司自主知识产权的 IDDC™抗体偶联技术平台开发的靶向钙黏蛋白（CDH17）的创新抗体偶联药物（ADC）。 ...

Core Viewpoint - Maiwei Biotech (688062.SH) has received FDA approval for its clinical trial application for the injectable drug 7MW4911, which is an innovative antibody-drug conjugate (ADC) targeting CDH17, a promising therapeutic target in various cancers [1] Company Summary - The FDA issued a "Study May Proceed Notification" for 7MW4911, allowing the clinical trial to commence [1] - 7MW4911 is developed based on the company's proprietary IDDC? antibody conjugation technology platform [1] - CDH17 is validated as a potential therapeutic target across multiple cancer types, showing significant overexpression in colorectal, gastric, and pancreatic cancers, which is associated with tumor invasion, metastasis, and poor prognosis [1] Industry Summary - CDH17 is expressed exclusively in the basolateral membrane of intestinal epithelial cells in normal tissues, making it an ideal target for precision intervention in gastrointestinal malignancies [1]

Group 1 - The core viewpoint of the news highlights the financial performance and trading activities of Maiwei Biotech, indicating a decline in revenue and net profit, alongside significant trading volumes in the stock market [1][2] - On August 14, 2023, Maiwei Biotech's stock price decreased by 0.64%, with a trading volume of 439 million yuan, and a net financing outflow of 772.01 million yuan [1] - As of August 14, 2023, the total margin balance for Maiwei Biotech was 502 million yuan, with a financing balance of 501 million yuan, representing 6.90% of the circulating market value, indicating a high level of financing activity [1] Group 2 - For the period ending March 31, 2025, Maiwei Biotech reported a revenue of 44.79 million yuan, a year-on-year decrease of 33.70%, and a net profit attributable to shareholders of -292 million yuan, a decline of 41.85% [2] - As of March 31, 2025, the number of shareholders for Maiwei Biotech increased to 16,100, reflecting a 4.22% rise, while the average circulating shares per person decreased by 4.04% to 12,705 shares [2] - The top ten circulating shareholders included several funds, with HSBC Jintrust Smart Manufacturing Pioneer Fund being the third largest, holding 4.705 million shares, a decrease of 136,200 shares from the previous period [2]

Group 1 - The core point of the article highlights the financing activities of Maiwei Biotechnology, indicating a net selling position in the recent trading days [1] - On August 13, the financing buy amount for Maiwei Biotechnology was 0.73 billion, ranking 334th in the market, with a financing repayment amount of 0.85 billion, resulting in a net sell of 11.75 million [1] - Over the last three trading days (August 11-13), the financing buy amounts were 0.39 billion, 0.53 billion, and 0.73 billion respectively [1] Group 2 - In terms of securities lending, there were no shares sold or net sold on that day [2]

Group 1 - The chemical pharmaceutical sector increased by 2.34% on August 13, with Shouyao Holdings leading the gains [1] - The Shanghai Composite Index closed at 3683.46, up 0.48%, while the Shenzhen Component Index closed at 11551.36, up 1.76% [1] - Notable gainers in the chemical pharmaceutical sector included Shouyao Holdings, which rose by 19.99% to a closing price of 55.94, and Weichip Bio, which increased by 14.39% to 41.18 [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 342 million yuan from main funds, while retail investors contributed a net inflow of 426 million yuan [2] - Major stocks with significant net inflows included Heng Rui Pharmaceutical with 55.1 million yuan and Fu Xing Pharmaceutical with 23.4 million yuan [3] - Conversely, stocks like ST Sailong and ST Suwu experienced notable net outflows of 4.97% and 3.70%, respectively [2]

Group 1 - The core viewpoint of the news highlights the financial performance and trading activities of Maiwei Biotech, indicating a decline in revenue and net profit while showing significant trading volume and high financing levels [1][2] Group 2 - On August 12, Maiwei Biotech's stock fell by 2.10%, with a trading volume of 427 million yuan, and a net financing purchase of 7.34 million yuan, indicating active trading despite the decline [1] - As of August 12, the total margin balance for Maiwei Biotech was 521 million yuan, accounting for 7.70% of its market capitalization, which is above the 90th percentile of the past year [1] - The company reported a revenue of 44.79 million yuan for the first quarter of 2025, a year-on-year decrease of 33.70%, and a net profit loss of 292 million yuan, down 41.85% year-on-year [2] - As of March 31, 2025, the number of shareholders increased by 4.22% to 16,100, while the average circulating shares per person decreased by 4.04% [2] - The main business revenue composition of Maiwei Biotech includes 72.38% from antibody drugs and 27.55% from technical services [1]

Group 1 - The core viewpoint of the news is that Maiwei Biotech has seen significant financing activity, indicating investor interest in the company [1][2]. - On August 12, Maiwei Biotech had a financing buy-in amount of 0.53 billion, ranking 399th in the market, with a financing repayment amount of 0.45 billion, resulting in a net buy of 7.34 million [1]. - Over the last three trading days (August 8-12), the financing buy-in amounts for Maiwei Biotech were 0.43 billion, 0.39 billion, and 0.53 billion respectively [2]. Group 2 - In terms of securities lending, on the same day, there were no shares sold or net sold, indicating no short selling activity [3].

Group 1 - The stock price of Maiwei Biotech-U is reported at 33.09 yuan, down by 0.71 yuan from the previous trading day, with a trading volume of 4.27 billion yuan [1] - Maiwei Biotech-U operates in the biopharmaceutical industry, focusing on the research, production, and sales of antibody drugs, including monoclonal antibodies and bispecific antibody drugs [1] - The company announced the completion of the first patient dosing in the clinical trial of its innovative drug 9MW2821 targeting Nectin-4ADC for patients with ADC-treated triple-negative breast cancer in the United States, marking its first overseas clinical trial [1] Group 2 - On August 12, the net outflow of main funds was 46.4564 million yuan, with a cumulative net outflow of 218 million yuan over the past five days [1]