On 22 January 2026, Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA) as the first and only HER2-directed antibody-drug conjugate for the second line treatment of adults with HER2 positive metastatic gastric or gastroesophageal junction cancer who have received one prior trastuzumab based regimen. This is the sixth indication approved for Enhertu® in China.
Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
Samsung Epis recently announced that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.