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）。 ...

格隆汇8月18日丨迈威生物(688062.SH)公布，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》（StudyMayProceedNotification），注射用7MW4911临床试验申请正式获得FDA许 可。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。 ...

融资方面，迈威生物当日融资买入4547.15万元。当前融资余额5.01亿元，占流通市值的6.90%，融资余 额超过近一年90%分位水平，处于高位。 融券方面，迈威生物8月14日融券偿还0.00股，融券卖出0.00股，按当日收盘价计算，卖出金额0.00元； 融券余量2.13万股，融券余额75.91万元，超过近一年80%分位水平，处于高位。 8月14日，迈威生物跌0.64%，成交额4.39亿元。两融数据显示，当日迈威生物获融资买入额4547.15万 元，融资偿还5319.16万元，融资净买入-772.01万元。截至8月14日，迈威生物融资融券余额合计5.02亿 元。 资料显示，迈威(上海)生物科技股份有限公司位于中国(上海)自由贸易试验区蔡伦路230号2幢105室,香 港九龙观塘道348号宏利广场5楼，成立日期2017年5月12日，上市日期2022年1月18日，公司主营业务涉 及治疗用生物制品的研发、生产与销售。主营业务收入构成为：抗体药物72.38%，技术服务27.55%， 其他(补充)0.08%。 来源：新浪证券-红岸工作室 机构持仓方面，截止2025年3月31日，迈威生物十大流通股东中，汇丰晋信智造先锋股票 ...

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].

公司宣布其靶向Nectin-4ADC创新药9MW2821用于ADC经治三阴性乳腺癌患者的临床试验在美国完成 首例患者给药。这是该药物在海外开展的首个临床试验。 8月12日主力资金净流出4645.64万元，近五日主力资金累计净流出2.18亿元。 风险提示：股市有风险，投资需谨慎。 本文源自金融界 迈威生物-U股价报33.09元，较前一交易日下跌0.71元。盘中最高触及34.61元，最低下探31.88元，成交 金额达4.27亿元。 迈威生物-U属于生物医药行业，专注于抗体药物研发、生产和销售。公司主要产品包括单克隆抗体药 物、双特异性抗体药物等创新生物药。 ...