Enhertu approved in China for new indication

29 December 2025

Enhertu (trastuzumab deruxtecan) has now been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer that has progressed on one or more endocrine therapies in the metastatic setting.

A specifically engineered HER2 directed DXd antibody drug conjugate (ADC), Enhertu was discovered by Daiichi Sankyo (TYO: 4568) and is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE: AZN).

Breast cancer is the second most common cancer in women in China. About 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths. HR positive, HER2 negative is the most common breast cancer subtype, accounting for about 70% of all breast cancers. Despite being classified as HER2 negative, many of these tumors still carry some level of HER2 expression.

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