China’s HER2-targeted ADC Trastuzumab Rezetecan gains NMPA approval for HER2-mutant NSCLC

CAR-T Digest - August 2020

29 May 2025: China’s HER2-targeted ADC Trastuzumab Rezetecan gains NMPA approval for HER2-mutant NSCLC

China approved Trastuzumab rezetecan, its first domestically developed antibody-drug conjugate (ADC), for treating HER2-mutant advanced non-small cell lung cancer (NSCLC) in patients previously treated with systemic therapy
Approval is based on the HORIZON-Lung study led by Prof. Lu Shun, showing a 74.5% response rate and 11.5 months median progression-free survival, doubling the efficacy of conventional therapies
The drug also showed reduced toxicity compared to traditional ADCs, drawing international attention for setting new global standards in ADC research
Developed by Hengrui Pharmaceuticals using its HRMAP platform, the drug showcases China’s growing capability in end-to-end ADC development
It has also received Breakthrough Therapy Designation for eight other cancers, including breast, colorectal, gastric, and ovarian cancers