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恒瑞医药:氟唑帕利胶囊上市许可申请获国家药监局受理
Hua Er Jie Jian Wen· 2025-10-27 11:13
Core Viewpoint - Heng Rui Medicine's application for the marketing authorization of Fluorouracil Capsules has been accepted by the National Medical Products Administration, intended for use in combination with Abiraterone and Prednisone for the first-line treatment of DNA repair gene-deficient positive (DRD+) metastatic castration-resistant prostate cancer [1] Group 1: Clinical Trials - The Phase III international multicenter clinical trial (496 cases, 1:1 randomization) is expected to meet the primary endpoint of superior efficacy by July 2025, showing significant improvement in imaging progression-free survival [1] Group 2: Approved Indications - Fluorouracil Capsules have already been approved for multiple indications, including ovarian cancer and breast cancer [1] Group 3: Industry Background - Prostate cancer has a high incidence rate, and DRD+ patients have a poor prognosis, indicating a significant clinical demand. The global sales of PARP inhibitors are projected to reach approximately $4.228 billion in 2024 [1] Group 4: R&D Investment - The cumulative R&D investment for Fluorouracil Capsules is approximately 1.113 billion yuan [1]