BIOKIN PHARMACEUTICAL(SH:688506) Ge Long Hui A P P·2025-11-23 07:55Core Viewpoint - The company, Sichuan Baili Tianheng Pharmaceutical Co., Ltd., has received the acceptance notice for its drug application for Iza-bren, a first-in-class EGFR×HER3 dual antibody ADC, marking a significant milestone in its development process [1][2] Group 1: Drug Development and Approval - Iza-bren is the world's first and only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials [2] - The acceptance of the New Drug Application (NDA) is based on the interim analysis results of the BL-B01D1-303 study [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic nasopharyngeal carcinoma [1] Group 2: Clinical Trials and Breakthrough Designations - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [2] - Seven indications for Iza-bren have been included in the breakthrough therapy designation list by the CDE, and one indication has been included in the priority review list [2] - Additionally, one indication has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) [2]