百利天恒：注射用iza-bren被纳入优先审评品种名单

Core Viewpoint - The company, BaiLi TianHeng, announced that its self-developed EGFR×HER3 dual antibody ADC (iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) of China, marking it as the first of its kind to enter Phase III clinical trials and receive priority review status [1] Group 1 - The drug, iza-bren, is the first EGFR×HER3 dual antibody ADC globally to be included in the priority review list [1] - Iza-bren has been recognized as a breakthrough therapy for recurrent or metastatic nasopharyngeal carcinoma that has failed at least two lines of chemotherapy and prior PD-1/PD-L1 monoclonal antibody treatment [1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met its primary endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1]