China Medical System Holdings Limited announced that on Jun, 22 2026 the National Medical Products Administration of the People’s Republic of China approved the New Drug Application for Silevimig Injection, a recombinant fully human bispecific antibody for passive immunization in adults after rabies virus exposure.

Silevimig targets two epitopes of the rabies virus glycoprotein, delivering immediate neutralization without hampering subsequent vaccine-induced active immunity. A Phase III adult trial met its primary endpoint of non-inferiority versus human rabies immune globulin, currently the main passive immunization product in China. A separate Phase III study in patients aged 2 to under 18 is ongoing.

The product is the world’s first bispecific antibody cleared for rabies post-exposure prophylaxis. According to the company, Silevimig can be manufactured at scale, requires a smaller dose than existing options and avoids the plasma-sourcing and potential infection risks associated with human rabies immune globulin.

Under a September 2025 agreement with Chongqing Genrix Biopharmaceutical Co., Ltd., China Medical System holds exclusive commercialization rights for Silevimig in mainland China and exclusive licensing rights across the Asia-Pacific, Middle East and North Africa. The collaboration runs for ten years from the Chinese marketing approval date, with automatic ten-year renewals thereafter.

The company plans to roll out Silevimig to improve access to passive rabies immunization in China, where roughly 40 million people face rabies exposure each year and only about 15% of Category III cases currently receive passive immunization.