Daiichi Sankyo and AstraZeneca’s Enhertu gains NMPA approval for HER2 GEJ

Back to news list

Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/daiichi-sankyo-astrazenecas-enher...

Published: Fri, 23 Jan 2026 09:26:05 +0000

Daiichi Sankyo and AstraZeneca have received approval from China's National Medicinal Products Administration (NMPA) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) cancer who have previously received trastuzumab-based therapy[1]. It is a monotherapy intended for the second line of treatment, which represents a shift from the previous indication in the third line and fills an important clinical gap[1]. The approval was granted on January 22, 2026, based on data from the phase III clinical trial DESTINY-Gastric04[1]. Enhertu is a specifically designed HER2-targeted antibody and cytostatic (ADC) drug[1]. This second-line indication expands the potential market by approximately 30% compared to the previous third-line only indication[1]. The drug is eligible for negotiations to be included in China's National Reimbursed Drug List (NRDL) in category 1 in 2026 and already has priority review status[1]. Enhertu continues to expand its position in the treatment of HER2-positive tumors, already having approvals for the treatment of breast and gastric cancer at the global level[1].