On September 28, 2026, information published on the official website of the National Medical Products Administration (NMPA) showed that Merck Sharp & Dohme (MSD)’s pembrolizumab injection (subcutaneous formulation, MK-3475A) has been approved for marketing in China. This approval marks the launch of a new administration formulation of pembrolizumab in China, offering a new therapeutic option for clinical practice. 

(Source: Official website of NMPA)

Pembrolizumab (brand name: Keytruda®) is a programmed death receptor-1 (PD-1) inhibitor. It enhances the body’s anti-tumor immune response by blocking PD-1-mediated immune inhibitory signals and is now widely used for the treatment of multiple solid tumors.

The newly approved MK-3475A is a novel formulation developed based on pembrolizumab and recombinant hyaluronidase technology for subcutaneous administration. Compared with conventional intravenous infusion, subcutaneous injection is expected to further streamline the administration process and improve treatment convenience.

Previously, Phase III clinical trials of MK-3475A have been conducted to compare different formulations. Among them, the MK-3475A-D77 study evaluated the pharmacokinetics, efficacy and safety of subcutaneous pembrolizumab versus intravenous pembrolizumab in patients with metastatic non-small cell lung cancer, meeting its predefined primary endpoint.

In the field of gynecologic oncology, pembrolizumab serves as one of the key agents for immunotherapy and is currently used for certain endometrial and cervical cancers. The approval of this subcutaneous formulation will further expand the available administration routes of pembrolizumab.