百利天恒: 四川百利天恒药业股份有限公司自愿披露关于iza-bren（EGFR×HER3双抗ADC）用于治疗晚期EGFR突变的非小细胞肺癌获得美国FDA突破性疗法认定的公告

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. announced that its subsidiary SystImmune, Inc. and partner Bristol-Myers Squibb (BMS) received Breakthrough Therapy Designation from the FDA for iza-bren, a dual-target antibody-drug conjugate (ADC) for treating advanced EGFR-mutant non-small cell lung cancer (NSCLC) [1][2]. Group 1: Drug Information - Iza-bren is the world's first-in-class and only EGFR×HER3 dual-target ADC currently in Phase III clinical trials, with over 40 clinical trials ongoing in China and the U.S. for various tumor types [2]. - The Breakthrough Therapy Designation is based on clinical trial data from studies BL-B01D1-101 and BL-B01D1-203 conducted in China, as well as the international multi-center study BL-B01D1-LUNG-101 conducted by SystImmune and BMS in the U.S., Europe, and Japan [3]. Group 2: Clinical Need and Efficacy - The designation highlights the significant unmet clinical need faced by patients after treatment with EGFR-TKI and platinum-based chemotherapy, as most patients experience disease progression approximately 18 months after first-line treatment [2]. - Iza-bren has shown encouraging efficacy and manageable safety in patients with EGFR-mutant NSCLC who progressed after third-generation EGFR TKI and platinum-based chemotherapy [3].