Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Fluorouracil capsules from the National Medical Products Administration, indicating progress in its clinical development for metastatic castration-resistant prostate cancer [1] Group 1: Clinical Trials and Results - The Phase III clinical trial (SHR3162-III-305) for Fluorouracil 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 global centers, with the primary endpoint assessed by an independent imaging review committee [1] Group 2: Drug Approvals and Indications - Fluorouracil capsules have received multiple approvals for various indications, including treatment for platinum-sensitive recurrent ovarian cancer with gBRCAm, maintenance therapy post-chemotherapy, and treatment for metastatic breast cancer with gBRCAm [2] - The drug has been approved for use in advanced epithelial ovarian cancer and other related cancers, indicating its expanding therapeutic applications [2] Group 3: Market Context and Competition - Fluorouracil is a PARP inhibitor, with several similar products like Olaparib, Rucaparib, Niraparib, and Talazoparib already approved and marketed in the U.S., highlighting a competitive landscape [3] - The global sales of these PARP inhibitors are projected to reach approximately $4.228 billion in 2024, indicating a significant market opportunity for Fluorouracil [3] - The cumulative R&D investment for Fluorouracil capsules has reached about 1.113 billion yuan, reflecting the company's commitment to developing this therapeutic option [3]