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先声药业(02096.HK):恩泽舒®获国家药品监督管理局批准在中国上市
Ge Long Hui· 2025-07-03 04:19
Core Insights - The approval of Enzeshou® (suvorexant injection) by the National Medical Products Administration (NMPA) in China marks a significant advancement in the treatment of platinum-resistant ovarian cancer, providing a much-needed therapeutic option for patients who have undergone limited prior systemic treatment [1][2] - Enzeshou® is a next-generation recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), demonstrating superior efficacy compared to existing treatments like Bevacizumab in preclinical studies [2] Group 1: Drug Approval and Indications - Enzeshou® received approval on June 30, 2025, for use in adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are platinum-resistant and have received no more than one prior systemic therapy [1] - The drug addresses a significant unmet clinical need in China, as there are currently no approved anti-angiogenic therapies for platinum-resistant ovarian cancer, particularly for patients previously treated with anti-angiogenic therapies [1] Group 2: Clinical Efficacy - The Phase III clinical trial (SCORES study) demonstrated significant improvements in progression-free survival (PFS), with median PFS extending from 2.73 months to 5.49 months, and a hazard ratio (HR) of 0.46 (0.35, 0.60), with a p-value of less than 0.0001 [2] - The trial also indicated a 23% reduction in the risk of death for the treatment group compared to the control group, with an overall survival (OS) hazard ratio of 0.77 and a p-value of 0.0304, marking Enzeshou® as the first vascular-targeted drug to show significant OS benefits in the platinum-resistant ovarian cancer population [2]