CMS: Class 1 Innovative Drug Silevimig Injection Approved in China, Becoming the World’s First Bispecific Antibody for Passive Immunization Against Rabies
SHENZHEN, CHINA – China Medical System Holdings Limited (867.HK/8A8.SG) (“CMS”, or the “Group”) is pleased to announce that, the New Drug Application for Silevimig Injection (GR1801, the “Product”), a Class 1 therapeutic biological product has been approved by the National Medical Products Administration of the People’s Republic of China (“NMPA”) and the drug registration certificate was obtained on 22 June 2026. The Product is indicated for passive immunization in adults following rabies virus exposure.
Silevimig Injection is the world’s first fully human bispecific antibody targeting dual epitopes of the rabies virus (“RABV”), which is consistent with the recommendations of the World Health Organization (“WHO”) for a “cocktail” therapeutic paradigm. It demonstrates broad neutraliza...