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百利天恒(688506.SH):注射用iza-bren(EGFR×HER3双抗ADC)纳入突破性治疗品种名单
智通财经网· 2025-09-10 09:16
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]