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]
迈威生物:注射用7MW4911临床试验申请获国家药品监督管理局和美国FDA受理