CMS: Class 1 Innovative Drug Silevimig Injection Approved in China, Becoming the Worlds First Bispecific Antibody for Passive Immunization Against Rabies
(firmenpresse) - SHENZHEN, June 22, 2026 - (ACN Newswire) - 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 neutralization, which can effectively neutralize different viral strains or genotypes of RABV, providing immediate protection. Moreover, it is the passive immunization product with the smallest dose for rabies, resulting in less injection volume and easier administration, which can effectively reduce patient pain and improve compliance. In addition, the Product can be manufactured at scale with standardized processes and controlled production cost, and also carries no risks of blood-borne infections, low immunogenicity, and minimal interference with vaccine-induced active immunization. The market for rabies passive immunization is substantial, yet existing passive immunization products are constrained by low market penetration and limitations in safety and accessibility. The approval of the Product will provide a new treatment option for patients requiring urgent post-exposure management against rabies in China.
The approval of Silevimig Injection expands the Group’s commercialized innovative drug portfolio to 8 products, with 6 more innovative drugs under marketing review and approximately 20 projects advancing clinical development, further strengthening a tiered innovation pipeline. As of now, CMS’s innovation transformation strategy has fully entered the value-harvesting phase. Leveraging the Group’s existing expert network and market resources, the commercialization rollout of Silevimig Injection is expected to proceed steadily providing sustained momentum to the Group’s performance growth.
About Rabies
Rabies is an acute zoonotic disease caused by RABV, clinically characterized by aerophobia, hydrophobia, pharyngeal muscle spasms, and progressive paralysis[1], with a case-fatality rate approaching 100%. At present, there is no proven treatment for rabies once clinical symptoms appear. Standardized post-exposure management, comprising wound care, vaccination, and passive immunization administered as needed, remains the most effective strategy[2]. As vaccine-induced antibodies require 1-2 weeks after the first dose of vaccine injection to reach protective levels, passive immunization provides immediate coverage[1]. According to the National Technical Guidelines for the Rabies Exposure Prophylaxis (2023 Edition), patients with Category III exposure and those with Category II exposure involving severe immunodeficiency should receive passive immunization at the same time as the first dose of rabies vaccine[3]. In China, more than 40 million people are exposed to rabies annually, of whom approximately 40% fall under Category III exposure[1]. However, due to factors such as limited awareness, high cost, and restricted accessibility, only about 15% of Category III cases receive passive immunization[1]. Currently, the primary approved passive immunization option in China is human rabies immune globulin (“HRIG”). However, HRIG must be sourced from healthy donors, making it difficult and costly to obtain. Furthermore, it carries potential risks of blood-borne infections. This has led to a low penetration rate of passive immunization products in China.
More information about Silevimig Injection
Silevimig Injection is a recombinant, fully human bispecific antibody against rabies virus. It targets the viral envelope glycoprotein (G protein) of RABV and blocks its interaction with host receptors by binding to epitopes I and III. Through this mechanism, Silevimig Injection specifically neutralizes the RABV prior to the establishment of full protection by active rabies vaccination.
In a Phase III clinical trial in adults, the Product met its primary efficacy endpoint, demonstrating non-inferior protective efficacy compared with HRIG, the currently most used passive immunization product in China. The study confirmed that the Product provides immediate protection during the early stages of rabies virus exposure without compromising the active immune response induced by vaccination. In addition, a Phase III clinical trial in children and adolescents aged 2 to
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Datum: 22.06.2026 - 16:44 Uhr
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