Core Viewpoint - The company has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Drug Information - Drug Names: Injection Karilizumab (injection) and Apalutamide capsules (capsule) [1] - The application is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide to platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for recurrent or metastatic cervical cancer patients [1]
恒瑞医药(01276.HK)创新药注射用卡瑞利珠单抗联合苹果酸法米替尼胶囊药品注册上市许可申请获受理