百利天恒iza-bren用于治疗局部晚期或转移性鼻咽癌的药品上市申请获得受理

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its self-developed EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China [1] Group 1: Product Development - Iza-bren is the world's first-in-class and new concept EGFR×HER3 dual antibody ADC, and it is the only one that has entered Phase III clinical trials globally [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various types of tumors [1] Group 2: Regulatory Milestones - As of now, Iza-bren has seven indications included in the CDE's list of breakthrough therapy products and one indication included in the priority review list by CDE [1] - Additionally, one indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]