HENGRUI PHARMA announced that its subsidiary, Shengdiya Biopharmaceutical, has received a notice of acceptance from the National Medical Products Administration for the marketing authorization application of its injectable drug SHR-A1811. The application has been included in the priority review process.

The submission for this new indication is based on a randomized, open-label, positive-controlled, multicenter Phase III clinical trial. The study was designed to evaluate the efficacy and safety of SHR-A1811 compared to standard treatment in HER2-positive advanced colorectal cancer patients who had previously failed treatment with oxaliplatin, fluoropyrimidines, and irinotecan. The trial also investigated the drug's immunogenicity and pharmacokinetic characteristics.

The clinical research was led by principal investigators from Shanghai Gaobo Cancer Hospital and The Second Affiliated Hospital of Zhejiang University School of Medicine, with participation from 40 centers nationwide. The primary endpoint was progression-free survival as assessed by an independent review committee using RECIST v1.1 criteria.

Study results demonstrated that SHR-A1811 significantly extended progression-free survival in HER2-positive advanced colorectal cancer patients compared to standard treatment, reducing the risk of disease progression or death. A beneficial trend in overall survival data has also been observed.