百利天恒：Iza-bren用于治疗局部晚期或转移性鼻咽癌被纳入优先审评程序

Core Viewpoint - The company announced that its self-developed drug, iza-bren (EGFR×HER3 dual antibody ADC), has been included in the priority review program for the treatment of locally advanced or metastatic nasopharyngeal carcinoma by the National Medical Products Administration (NMPA) [1][2] Group 1 - Iza-bren is the world's first and only EGFR×HER3 dual antibody ADC to enter Phase III clinical trials [1] - The drug is specifically for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy (with at least one line including platinum) after prior treatment with PD-1/PD-L1 monoclonal antibodies [1][2] - Iza-bren is also included in the breakthrough therapy list by the Center for Drug Evaluation (CDE) in China [2] Group 2 - The company is conducting over 40 clinical trials for iza-bren targeting various tumor types in both China and the United States [2] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met the primary endpoint [2] - The company has completed pre-New Drug Application (Pre-NDA) communication with CDE regarding this indication [2]