Jiangsu Hengrui Pharmaceuticals (01276): The drug marketing authorization application for Fluorouracil Capsules has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that it has recently received a "Notice of Acceptance" from the National Medical Products Administration (referred to as "NMPA" below) for the drug approval application of the Fluorouracil Palir Capsule. In July 2025, the Phase III clinical trial (SHR3162-III-305) results of Fluorouracil Palir combined with Abiraterone and Prednisone (AA-P) for the first-line treatment of metastatic castration-resistant prostate cancer met the pre-specified efficacy standard. This study is a random, double-blind, placebo-controlled international multicenter Phase III clinical trial evaluating Fluorouracil Palir combined with AA-P versus placebo combined with AA-P for the first-line treatment of metastatic castration-resistant prostate cancer, with the primary endpoint being progression-free survival assessed by a blinded independent central review committee (BICR) based on RECIST v1.1 and PCWG3 criteria, and the key secondary endpoint being overall survival. The study was led by Professor Ye Dingwei from Fudan University Affiliated Cancer Hospital, with a total of 132 centers worldwide participating, and a total of 496 patients randomly assigned in a 1:1 ratio to the Fluorouracil Palir combined with AA-P group and the placebo combined with AA-P group. The results showed a significant and clinically meaningful improvement in progression-free survival with Fluorouracil Palir combined with AA-P compared to the placebo combined with AA-P group. Fluorouracil Palir Capsule has been approved for multiple indications, including: in December 2020 for the treatment of platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer with germline BRCA mutation (gBRCAm) previously treated with two or more lines of chemotherapy; in June 2021 for the maintenance treatment of adults with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved complete or partial response to platinum-based chemotherapy; in May 2024 for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved complete or partial response to first-line platinum-based chemotherapy; and in December 2024 for the treatment of adults with germline BRCA-mutated human epidermal growth factor receptor 2-negative metastatic breast cancer who have received prior chemotherapy for locally advanced, adjuvant or metastatic disease and hormone receptor-positive breast cancer patients who have received prior endocrine therapy or are considered inappropriate for endocrine therapy. Fluorouracil Palir Capsule is a poly ADP-ribose polymerase (PARP) inhibitor that selectively kills tumor cells with DDR mutations. Several PARP inhibitors have been approved globally, with similar products such as Olaparib, Rucaparib, Niraparib, and Talazoparib being sold in the United States. Olaparib was approved in China in 2018, and Niraparib was introduced by ZAI LAB and approved in China in 2019. Domestic products include BEIGENE's Pamiparib Capsule and Enpai Pharmaceuticals' Senaparib Capsule. According to the EvaluatePharma database, the combined global sales of Olaparib, Niraparib, and Talazoparib in 2024 amounted to approximately $4.228 billion. As of now, the total research and development investment in Fluorouracil Palir Capsule projects is approximately RMB 1.113 billion.