Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has received the acceptance notice from the National Medical Products Administration for its innovative drug, iza-bren, which is the world's first EGFR×HER3 dual-target ADC entering Phase III clinical trials [1][2] Group 1: Drug Information - The drug name is BL-B01D1/iza-bren, and it is an injectable formulation [1] - The intended indication is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including one line containing platinum, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] - Iza-bren is recognized as a first-in-class and new concept drug, and it is the only EGFR×HER3 dual-target ADC to have its marketing application accepted [2] Group 2: Clinical Trials and Regulatory Status - 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 list by the CDE, and one indication has been designated as a priority review product [2]
证券代码：688506 证券简称：百利天恒 公告编号：2025-086