By Fineline Cube 
On August 22, 2025, Daiichi Sankyo (TYO: 4568) submitted a marketing authorization application for Enhertu (trastuzumab deruxtecan injection) to China’s National Medical Products Administration (NMPA), which has been included in the priority review and approval process. This application seeks approval for Enhertu as a neoadjuvant treatment for HER2-positive breast cancer patients, marking the seventh marketing application in China and the fourth for a breast cancer indication.
Enhertu Mechanism and Composition
Enhertu is an antibody-drug conjugate (ADC) targeting HER2, comprising a humanized anti-HER2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor, DXd. The drug payload is selectively released within tumor cells, disrupting DNA and leading to cell death.
Clinical Trial Results
The application is supported by positive results from the DESTINY-Breast11 (DB-11) study. The trial demonstrated statistically significant improvements in pathological complete response (pCR) for patients with high-risk, early-stage HER2-positive breast cancer in the T-DXd-THP group compared to the ddAC-THP group. Benefits were also observed in event-free survival (EFS) and residual cancer burden (RCB). The T-DXd-THP regimen showed a favorable safety profile compared to the control group.-Fineline Info & Tech