On 7 May 2026, Daiichi Sankyo announced that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) received approval from Korea’s Ministry of Food and Drug Safety on 30 April 2026 for the treatment of HER-2 positive metastatic breast cancer and gastric cancer.
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.
In January 2026, Samsung Epis Holdings announced that a trastuzumab deruxtecan biosimilar was added to Samsung Bioepis’ pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.