Global Finance News
27 Mar 2026, 16:35
ENHERTU, developed by Daiichi Sankyo and AstraZeneca, has been approved in China for the neoadjuvant treatment of HER2-positive early-stage breast cancer.
The approval, granted by China’s National Medical Products Administration, marks the first global use of ENHERTU in a curative-intent early breast cancer setting and the first HER2-directed antibody-drug conjugate approved in China for this purpose.
The decision is based on Phase 3 DESTINY-Breast11 trial results, where ENHERTU followed by THP achieved a significantly higher pathologic complete response rate of 67.3%, compared to 56.3% with standard therapy.
The treatment demonstrated a manageable safety profile consistent with prior data, with no new safety concerns identified. The approval is conditional, pending confirmation of long-term clinical benefits in ongoing studies.
This marks the seventh approval for ENHERTU in China in three years, highlighting rapid adoption of the therapy in a market with high breast cancer incidence and significant unmet medical need.
The approval, granted by China’s National Medical Products Administration, marks the first global use of ENHERTU in a curative-intent early breast cancer setting and the first HER2-directed antibody-drug conjugate approved in China for this purpose.
The decision is based on Phase 3 DESTINY-Breast11 trial results, where ENHERTU followed by THP achieved a significantly higher pathologic complete response rate of 67.3%, compared to 56.3% with standard therapy.
The treatment demonstrated a manageable safety profile consistent with prior data, with no new safety concerns identified. The approval is conditional, pending confirmation of long-term clinical benefits in ongoing studies.
This marks the seventh approval for ENHERTU in China in three years, highlighting rapid adoption of the therapy in a market with high breast cancer incidence and significant unmet medical need.