Hengrui Medicine has received its marketing authorization application for a new indication for its Ruikang trastuzumab injection and has been included in the priority review process

CAR-T Digest - August 2020

Weekly Digest - September 2025

17 September 2025: Hengrui Medicine has received its marketing authorization application for a new indication for its Ruikang trastuzumab injection and has been included in the priority review process

Hengrui Medicine’s subsidiary Suzhou Shengdia Biopharmaceutical received acceptance from China’s National Medical Products Administration (NMPA) for a new indication of Ruikang Trastuzumab Injection (SHR-A1811) to treat locally advanced or metastatic HER2-positive adult breast cancer after prior anti-HER2 therapy
The application has been included in the NMPA’s priority review process
The Phase 3 trial (SHR-A1811-III-301) compared SHR-A1811 with pyrotinib plus capecitabine in previously treated HER2-positive breast cancer across 54 centers in China, with progression-free survival (PFS) as the primary endpoint
In July 2025, an independent data monitoring committee confirmed that the study met its prespecified superiority criteria, showing SHR-A1811 significantly reduced the risk of disease progression or death versus the control group with good safety
SHR-A1811 was already approved in China in May 2025 for HER2-mutant unresectable locally advanced or metastatic non-small cell lung cancer after at least one systemic treatment