Core Viewpoint - The company, Baili Tianheng (688506.SH), has announced that its self-developed drug, iza-bren (EGFR × HER3 dual antibody ADC), has been included in the breakthrough therapy list by the National Medical Products Administration's Drug Review Center, marking a significant milestone as it is the first-in-class and the only drug to reach Phase III clinical trials for patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1] Summary by Categories - **Product Development** - Iza-bren is a first-in-class and new concept drug that targets EGFR and HER3 [1] - The drug has reached Phase III clinical trials, indicating advanced development status [1] - **Regulatory Milestone** - The drug has been included in the breakthrough therapy list by the National Medical Products Administration [1] - This inclusion signifies recognition of the drug's potential to address unmet medical needs in specific cancer types [1] - **Target Patient Population** - The drug is aimed at patients suffering from platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1]

Group 1 - The company has completed the enrollment of the first subject in the Phase III clinical trial for its first-in-class drug, Iza-bren, targeting platinum-resistant recurrent epithelial ovarian cancer [1] - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials globally [1] - The drug is currently involved in over 40 clinical trials in China and the United States for various tumor types, including non-small cell lung cancer, small cell lung cancer, breast cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and urothelial carcinoma [2]

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].