Group 1 - The core viewpoint of the news highlights a surge in virus prevention concept stocks, particularly in response to the release of the 2025 treatment plan for Chikungunya virus, which has led to significant stock price increases for several companies in the pharmaceutical sector [1][2] - Companies such as Lide Man and Lianhuan Pharmaceutical saw their stock prices rise by 20% and nearly 10% respectively, indicating strong market interest and potential investment opportunities in the sector [2] - The news also mentions that there is currently no available vaccine for the Chikungunya virus in China, which may drive demand for preventive measures and related pharmaceutical products [1] Group 2 - Specific stock performance data shows that Hotgen Biotech increased by over 9%, while Zhongsheng Pharmaceutical rose by over 7%, reflecting a broader trend of growth among virus prevention stocks [1][2] - The total market capitalization of Lide Man is reported at 4.597 billion, while Lianhuan Pharmaceutical stands at 5.538 billion, indicating substantial company valuations in the context of the current market dynamics [2] - Year-to-date performance shows that Hotgen Biotech has increased by 244.50%, suggesting a strong upward trend in investor confidence and market performance for this company [2]

证券代码：688062 证券简称：迈威生物 公告编号：2025-038 迈威（上海）生物科技股份有限公司 获得国家药品监督管理局和美国 FDA 受理的公告 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。 重要内容提示： 近日，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"）收到：1）国家药品监督管理局（NMPA）签发的《受理通知书》，注射用 出具的 IND Acknowledgement Letter，确认已收到公司就注射用 7MW4911 递交 的 IND 申请。由于药品的研发周期长、审批环节多，容易受到一些不确定性因 素的影响，敬请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如 下： 一、药品基本情况 （一）国家药品监督管理局受理情况 药品名称：注射用 7MW4911 申请事项：境内生产药品注册临床试验 受理号：CXSL2500640 自愿披露关于注射用 7MW4911 临床试验申请 申请人：迈威（上海）生物科技股份有限公司 二、药品的其他相关情况 向钙黏蛋白 17（CDH17）的创新抗体 ...

证券日报网讯 7月31日晚间，迈威生物发布公告称，近日，公司收到：国家药品监督管理局（NMPA） 签发的《受理通知书》，注射用7MW4911的临床试验申请已获正式受理；美国食品药品监督管理局 （FDA）出具的INDAcknowledgementLetter，确认已收到公司就注射用7MW4911递交的IND申请。 （文章来源：证券日报） ...

7月31日晚，微芯生物（688321）发布公告称，公司的全资子公司微芯生物科技（美国）有限公司于7月 31日收到美国食品药品监督管理局（简称"FDA"）签发的关于允许公司自主研发的CS231295开展治疗 晚期实体瘤的I期临床试验的通知。CS231295是一种透脑Aurora B选择性抑制剂，具有良好的血脑屏障 穿透能力，对脑部原发或脑转移性肿瘤具有明显治疗优势。 资料显示，微芯生物成立于2001年8月，主营业务是药物技术开发、相关成果商业应用。 捷佳伟创：上半年净利润预增38.65%–59.85% 7月31日晚，捷佳伟创（300724）发布2025年半年度预告，公司预计上半年实现归属于上市公司股东的 净利润17亿元至19.6亿元，同比增长38.65%至59.85%；预计实现扣除非经常性损益后的净利润15.49亿 元至18.09亿元，同比增长31.37%至53.41%。 资料显示，捷佳伟创成立于2007年6月，主营业务是太阳能电池设备研发、生产和销售。 所属行业：电力设备–光伏设备–光伏加工设备 微芯生物：CS231295临床试验申请获FDA批准 所属行业：医药生物–化学制药–化学制剂 中国石化：上半年净利润 ...

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development pipeline [1] Group 1 - The injectable 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17) developed based on the company's proprietary IDDC antibody conjugation technology platform [1] - The acceptance of the clinical trial application by NMPA marks a significant milestone for the company in advancing its drug candidate [1] - The receipt of the IND Acknowledgement Letter from the FDA confirms that the company has submitted its IND application for 7MW4911, facilitating its entry into the U.S. market [1]

格隆汇7月31日丨迈威生物(688062.SH)公布，公司收到：1）国家药品监督管理局（NMPA）签发的《受 理通知书》，注射用7MW4911的临床试验申请已获正式受理；2）美国食品药品监督管理局（FDA）出 具的INDAcknowledgementLetter，确认已收到公司就注射用7MW4911递交的IND申请。 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。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，显著增强抗肿瘤活性。 ...

Core Viewpoint - Maiwei Biotech (688062.SH) has received regulatory approvals for its innovative antibody-drug conjugate (ADC) 7MW4911, marking a significant step in its clinical development [1] Regulatory Approvals - The company has received a formal acceptance notice from the National Medical Products Administration (NMPA) for the clinical trial application of 7MW4911 [1] - Additionally, the U.S. Food and Drug Administration (FDA) has issued an IND Acknowledgement Letter confirming receipt of the IND application for 7MW4911 [1] Product Development - 7MW4911 is developed based on the company's proprietary IDDC? antibody conjugate technology platform, targeting cadherin-17 (CDH17) [1] - CDH17 is identified as a promising therapeutic target validated by multi-omics across various cancer types, with significant overexpression in colorectal, gastric, and pancreatic cancers [1] - The design of 7MW4911 integrates three core components: a high-specificity monoclonal antibody Mab0727, a novel cleavable linker, and a proprietary DNA topoisomerase I inhibitor MF-6 [1] Mechanism of Action - MF-6 is designed to overcome multi-drug resistance mechanisms, enhancing anti-tumor activity through excellent plasma stability, controllable drug release, and a strong bystander effect [1]

证券代码：688062 证券简称：迈威生物 公告编号：2025-038 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 获得国家药品监督管理局和美国 FDA 受理的公告 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。 重要内容提示： 近日，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"）收到：1）国家药品监督管理局（NMPA）签发的《受理通知书》，注射用 7MW4911 的临床试验申请已获正式受理；2）美国食品药品监督管理局（FDA） 出具的 IND Acknowledgement Letter，确认已收到公司就注射用 7MW4911 递交 的 IND 申请。由于药品的研发周期长、审批环节多，容易受到一些不确定性因 素的影响，敬请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如 下： 一、药品基本情况 （一）国家药品监督管理局受理情况 药品名称：注射用 7MW4911 申请事项：境内生产药品注册临床试验 受理号：CXSL2500640 申请人：迈威（上海）生物 ...

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development process [1] Group 1: Regulatory Approvals - The company announced that it has received a "Notice of Acceptance" from the NMPA for its clinical trial application for 7MW4911 [1] - The FDA has acknowledged receipt of the IND application for 7MW4911, confirming the company's compliance with regulatory requirements [1] Group 2: Product Development - 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17), developed based on the company's proprietary IDDC™ antibody conjugation technology platform [1]

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration, indicating progress in its development of a novel antibody-drug conjugate targeting CDH17, which is overexpressed in various gastrointestinal cancers [1] Group 1: Clinical Development - The injectable 7MW4911's clinical trial application has been officially accepted by the National Medical Products Administration [1] - The U.S. Food and Drug Administration has acknowledged receipt of the IND application for 7MW4911 [1] Group 2: Product Details - 7MW4911 is developed based on the company's proprietary IDDC antibody-drug conjugate technology platform [1] - The drug targets calcium adhesion protein 17 (CDH17), which is significantly overexpressed in colorectal, gastric, and pancreatic cancers [1] - The high expression of CDH17 is closely related to tumor invasion, metastasis, and poor prognosis [1] Group 3: Therapeutic Potential - 7MW4911 demonstrates the potential to be a transformative therapy for advanced gastrointestinal solid tumors through CDH17-mediated selective cytotoxic payload release [1]