Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC, Iza-bren, which is the only one to enter Phase III clinical trials globally [1][2] Group 1: Drug Development and Clinical Trials - Iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma, as determined by an independent data monitoring committee (iDMC) [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial, and Iza-bren has been included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1] Group 2: Regulatory Status and Breakthrough Designations - Iza-bren is the first EGFR×HER3 dual antibody ADC to have its drug application accepted globally and is currently undergoing over 40 clinical trials for various tumor types in China and the United States [2] - As of now, Iza-bren has seven indications included in the breakthrough therapy designation list by the NMPA, two indications in the priority review list, and one indication recognized by the U.S. Food and Drug Administration (FDA) as a breakthrough therapy [2]