Hengrui Medicine drug candidates get priority review, breakthrough status

Jiangsu Hengrui Medicine's subsidiary, Suzhou Suncadia Biopharmaceuticals, has received NMPA acceptance and priority review for its SHR-A1811 injection. The drug is for HER2-positive breast cancer patients who have undergone prior HER2-targeted treatments. This follows the drug's prior approval in May 2025 for HER2-activating mutated non-small cell lung cancer. Cumulative R&D investment for SHR-A1811 is approximately CNY 1,338.83 million.

Concurrently, Hengrui Medicine's HRS-5635 injection, developed by its subsidiary Fujian Hengrui Pharmaceutical, has been granted breakthrough therapy designation by the NMPA for chronic hepatitis B. This siRNA drug, the first of its kind developed by the company targeting HBV in the liver, has shown potential in achieving functional cures in Phase II clinical trials.

The total R&D investment for HRS-5635 is approximately CNY 151.68 million. Both developments highlight the company's commitment to advancing innovative therapies in areas of high unmet medical need.