CMS(00867.HK): Class 1 New Drug Silevimig Injection Granted NMPA Marketing Approval, the World’s First Bispecific Antibody for Rabies Passive Immunization

NewTimeSpace News: On 22 June 2026, China Medical System Holdings Limited (00867.HK) issued a voluntary and business progress announcement disclosing that Silevimig Injection has secured marketing approval from the NMPA.

Silevimig Injection is a recombinant fully human bispecific antibody targeting rabies virus (RABV). It binds to epitopes I and III of the viral envelope glycoprotein of RABV to block virus-receptor binding, specifically neutralizing rabies virus before active rabies vaccination delivers full protective efficacy. As the world’s first bispecific antibody for rabies passive immunization, its molecular design complies with the WHO-recommended "cocktail-style" combination formulation. The pivotal Phase III clinical trial conducted in Chinese adult subjects met the primary efficacy endpoints.

Rabies boasts a nearly 100% mortality rate, and standardized post-exposure prophylaxis is the most effective intervention strategy. Over 40 million people in China sustain rabies virus exposure each year, 40% of whom present with Grade III exposure, yet merely around 15% receive passive immunization preparations. Human Rabies Immune Globulin (HRIG), the dominant passive immunization product available domestically, suffers from limited supply, high pricing and potential risks of blood-borne infections.

This product currently features the lowest dosage among all rabies passive immunization agents. Its low administration volume enables smooth injection, effectively alleviating patient pain and boosting treatment adherence. In September 2025, the Group entered into an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical via its subsidiary, acquiring exclusive commercialization rights for the product in mainland China.