Skip to content
mp.weixin.qq.com· 默沙东中国·· 18 days agoPickScore60

NMPA Approves Subcutaneous Pembrolizumab, First of Its Kind in China

默沙东PD-1抑制剂帕博利珠单抗注射液(皮下注射)在华获批

In brief

China's NMPA has approved Merck's subcutaneous formulation of the PD-1 inhibitor pembrolizumab, covering 19 solid tumour indications, making it the first and currently only subcutaneous PD-1 inhibitor approved in China. The approval, announced on 29 September 2026, is based on data from study MK-3475A-D77. The approval covers the same indication set as the existing intravenous formulation.

Why it matters

First subcutaneous PD-1 inhibitor approval in China affects a top-selling oncology drug's delivery options.

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

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