Enhertu gains new approval in China

13 August 2024

Japanese drugmaker Daiichi Sankyo’s (TYO: 4568) shares rose 5.5% to 5,758 yen this morning, after it announced a third approval in China for Enhertu (trastuzumab deruxtecan), which is co-marketed with UK pharma major AstraZeneca (LSE: AZN)>

Enhertu has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens.

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Gastric06 Phase II trial. Full approval for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

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