New Approval in China for Enhertu, a Key Antibody-Drug Conjugate from Daiichi Sankyo and AstraZeneca

Stock News
08/13

A new indication for the antibody-drug conjugate (ADC) Enhertu, developed in collaboration between Daiichi Sankyo and AstraZeneca PLC (AZN.US), has secured approval for marketing in China as of August 12.

This newly approved use targets the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, where Enhertu is administered in combination with pertuzumab.

Enhertu (DS-8201) is a HER2-directed ADC, initially developed by Daiichi Sankyo and now co-developed and commercialized globally with AstraZeneca PLC (AZN.US). The drug consists of a HER2-targeting antibody, a cleavable tetrapeptide linker, and a topoisomerase I inhibitor payload (a derivative of exatecan known as DXd), with a drug-to-antibody ratio of approximately 8.

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