Jiangsu Hengrui Pharmaceuticals (01276): Application for market approval of injection Rituximab accepted and included in priority review process.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the application for marketing approval of the drug Injection of Ruconestuzumab. The application has been included in the priority review process. The new indication application is based on a randomized, open-label, positive drug-controlled, multicenter Phase III clinical trial. The study aims to evaluate the efficacy and safety of Ruconestuzumab (SHR-A1811) compared to standard treatment in HER2-positive advanced colorectal cancer patients who have failed treatment with oxaliplatin, fluoropyrimidine, and irinotecan; as well as explore the drug's immunogenicity and pharmacokinetic characteristics. The study is jointly conducted by Kang-Ho Hospital, Shanghai, Professor Lee Jin, CKH HOLDINGS, Second Affiliated Hospital of Zhejiang University School of Medicine, Professor Yuan Ying, with the participation of 40 centers nationwide. The primary endpoint is the independent imaging review committee (IRC)-assessed progression-free survival (PFS) based on RECIST v1.1 criteria. The study results show that compared to the standard treatment, Ruconestuzumab significantly prolongs PFS in HER2-positive advanced colorectal cancer patients, reducing the risk of disease progression or death. Overall survival (OS) data shows a trend towards benefit.