Hengrui Pharma recently announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for Wevdury (fuzuloparib) in combination with abiraterone acetate and prednisone or prednisolone for the proposed indication of treating metastatic Castration-Resistant Prostate Cancer (mCRPC) in adult patients.

This application is based on data from the SHR3162-3-305 study (FUZUPRO, NCT04691804), an international, multicenter, randomised, double-blind, placebo-controlled phase 3 trial.

The study aimed to assess the efficacy and safety of fuzuloparib in combination with abiraterone and prednisone (AA-P) versus placebo in combination with AA-P as first-line treatment in patients with mCRPC.

Professor Dingwei Ye of Fudan University Shanghai Cancer Center served as the global lead principal investigator. The trial was conducted jointly at 132 sites worldwide.

A total of 496 patients with mCRPC were enrolled in the study (including 236 patients enrolled outside the Chinese mainland and randomly assigned at a 1:1 ratio to the experimental arm (fuzuloparib plus AA-P) or the control arm (placebo plus AA-P).

The primary endpoint was radiographic Progression-Free Survival (rPFS) assessed by Blinded Independent Central Review (BICR).

The study results showed that, as first-line treatment for mCRPC, the experimental arm significantly extended rPFS compared with the control arm, with a manageable safety profile. As of the data cutoff on March 23, 2025, the median rPFS was 24.8 months in the experimental arm versus 19.9 months in the control arm (Hazard Ratio [HR] = 0.71; 95 percent CI 0.55–0.91).

These findings were orally presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO).