Core Insights - Jiangsu Hengrui Medicine Co., Ltd. has received the acceptance notification from the National Medical Products Administration for the marketing authorization application of Fluorouracil Capsules [1] - The drug is intended for first-line treatment of metastatic castration-resistant prostate cancer with DNA repair gene defects, in combination with Abiraterone and Prednisone or Prednisolone [1] Group 1 - The drug name is Fluorouracil Capsules, and it is in capsule form with acceptance number CXHS2500129 [1] - The application is currently in the submission phase, with Jiangsu Hengrui Medicine as the applicant [1] - The proposed indication is for use in combination with Abiraterone and Prednisone or Prednisolone for treating DRD+ metastatic castration-resistant prostate cancer [1] Group 2 - A Phase III clinical trial (SHR3162-III-305) for Fluorouracil in combination with Abiraterone and Prednisone has met its predefined efficacy standards [2] - The study is a randomized, double-blind, placebo-controlled international multicenter trial involving 496 patients across 132 centers [2] - Results indicate a significant and clinically meaningful improvement in imaging progression-free survival for the Fluorouracil and Abiraterone-Prednisone group compared to the placebo group [2]