Core Viewpoint - Heng Rui Medicine has received acceptance for the marketing authorization application of Fluozolapril capsules from the National Medical Products Administration, indicating progress in the drug's approval process for treating metastatic castration-resistant prostate cancer [1] Group 1: Clinical Trial Results - The Phase III clinical trial (SHR3162-III-305) for Fluozolapril in combination with Abiraterone and Prednisone (AA-P) achieved predefined efficacy standards, demonstrating significant improvement in imaging progression-free survival compared to the placebo group [1] - The trial involved 496 patients randomized in a 1:1 ratio across 132 centers globally, with the primary endpoint assessed by an independent imaging review committee [1] Group 2: Drug Approval History - Fluozolapril has received multiple approvals for various indications, including treatment for gBRCAm ovarian cancer and maintenance therapy for advanced epithelial ovarian cancer [2] - The drug was first approved in December 2020 for platinum-sensitive recurrent ovarian cancer and has since expanded its indications through 2024 [2] Group 3: Market Context - Fluozolapril is a PARP inhibitor, with several similar products already approved globally, including Olaparib, Rucaparib, Niraparib, and Talazoparib, which collectively generated approximately $4.228 billion in global sales in 2024 [3] - The total R&D investment for Fluozolapril-related projects has reached approximately 1.113 billion yuan [3]