Hengrui Pharma(SH:600276) Zhi Tong Cai Jing·2025-09-30 10:33Core Viewpoint - Heng Rui Medicine 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] Group 1: Drug Development - The application for market approval 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] Group 2: Efficacy and Safety - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for patients with recurrent or metastatic cervical cancer [1]