百利天恒(688506.SH)：自主研发的全球首创EGFR×HER3双抗ADC药物iza-bren被纳入优先审评程序

Core Viewpoint - The company, Baillie Gifford, has announced that its self-developed first-in-class 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 EGFR×HER3 dual antibody ADC to receive such recognition globally [1][1][1] Group 1 - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials, and it is currently undergoing over 40 clinical trials for various types of tumors in both China and the United States [1][1][1] - The NMPA has included Iza-bren in the list of breakthrough therapy products for the treatment of recurrent or metastatic nasopharyngeal carcinoma, which has previously failed at least two lines of chemotherapy [1][1][1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met the primary research endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1][1][1]