百利天恒：注射用BL-B01D1/iza-bren的药品上市申请获得受理

Core Viewpoint - The company, Baili Tianheng (688506.SH), has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China, marking a significant milestone in the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren is the first EGFR×HER3 dual antibody ADC to have its NDA accepted globally [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) in China [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] Group 2 - As of now, iza-bren has seven indications included in the CDE's list of breakthrough therapy designations [1] - Two indications have been included in the CDE's priority review list [1] - One indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]