Core Viewpoint - The company has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC, iza-bren, which is currently in Phase III clinical trials [1][2] Group 1: Drug Development and Approval - The National Medical Products Administration (NMPA) has issued an acceptance notice for the NDA of iza-bren, based on interim analysis results from the BL-B01D1-303 study [1] - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials and is the first of its kind to have its NDA accepted globally [2] - The drug is being tested in over 40 clinical trials for various tumor types in both China and the United States [2] Group 2: Regulatory Status and Designations - Seven indications for iza-bren have been included in the breakthrough therapy designation list by the CDE, with one indication also receiving priority review status [2] - Additionally, one indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [2]

Group 1 - The company has completed the enrollment of the first subject in the Phase III clinical trial for its first-in-class drug, Iza-bren, targeting platinum-resistant recurrent epithelial ovarian cancer [1] - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials globally [1] - The drug is currently involved in over 40 clinical trials in China and the United States for various tumor types, including non-small cell lung cancer, small cell lung cancer, breast cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and urothelial carcinoma [2]