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mp.weixin.qq.com·· 24 days agoScore60

NMPA Approves MSD's Subcutaneous Pembrolizumab MK-3475A in China

In brief

China's NMPA approved MSD's subcutaneous pembrolizumab injection (MK-3475A) on September 28, per the agency's website. The formulation, known as a subcutaneous version of Keytruda, had already been approved by the US FDA in September 2025 as Keytruda QLEX and in the EU in November 2025. The approval gives pembrolizumab a new route of administration in China.

Source: mp.weixin.qq.com · mp.weixin.qq.com

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org