CMS (00867; 8A8.SG) Reaches Cooperation Agreement for Two Innovative Biological Products: Vikontamab Injection for Tetanus Passive Immunization and Siravemab Injection for Rabies Passive Immunization

Stock News
09/23

On September 22, 2025, CMS Holdings Limited ("CMS", 00867) announced that through its subsidiaries, it has signed exclusive cooperation agreements with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. ("Zhixiang Jintai") for two innovative biological products in the infectious disease prevention and control field. The agreements grant CMS exclusive commercialization rights in mainland China and exclusive licensing rights in the Asia-Pacific region (excluding mainland China) as well as the Middle East and North Africa.

Both products are Class 1 therapeutic biological products currently under China NDA review. Vikontamab (GR2001) injection is indicated for passive immunization against tetanus, while Siravemab (GR1801) injection is indicated for passive immunization following suspected rabies virus exposure.

Vikontamab injection is a recombinant humanized monoclonal antibody against tetanus toxin with excellent safety profile and superior efficacy compared to Human Tetanus Immunoglobulin (HTIG), providing rapid and durable protection for patients. The product targets the C-terminal of the heavy chain of tetanus neurotoxin (TeNT-Hc). TeNT is a single-chain protein of approximately 150kDa that undergoes post-translational modification to form an active toxin composed of heavy and light chains. The product specifically binds to TeNT-Hc, blocking its entry into neuronal cells and providing passive immune protection. The Phase III clinical trial of Vikontamab injection for tetanus passive immunization has achieved its primary efficacy endpoint. In May 2024, Vikontamab injection was included in the breakthrough therapy designation list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and its New Drug Application (NDA) was accepted by CDE on May 22, 2025.

Siravemab injection is the world's first recombinant fully human bispecific antibody for rabies passive immunization. The product works by targeting and binding to epitopes I and/or III of the rabies virus G protein, blocking its binding to receptors, and preventing viral invasion of nerves before the rabies vaccine's active immunization takes full protective effect, thus preventing rabies. This aligns with the World Health Organization (WHO) recommended "cocktail therapy" approach targeting different antigenic sites. Additionally, the product enables large-scale standardized stable production with broad neutralization spectrum, low immunogenicity, minimal interference with vaccine active immunization, and controllable costs. On January 14, 2025, its NDA for passive immunization in adults following suspected rabies virus exposure was accepted by CDE. Furthermore, its clinical trial application for passive immunization in children and adolescents aged 2 to under 18 years following suspected rabies virus exposure was approved by NMPA in July 2025, with Phase III clinical trials currently underway.

CMS remains committed to developing innovative products with clinical value and differentiated advantages. The passive immunization markets for tetanus and rabies are extensive, while existing passive immunization products have certain limitations in terms of safety and accessibility. The anticipated market approval of Vikontamab injection and Siravemab injection is expected to provide new passive immunization and prevention options for patients exposed to tetanus and rabies, while creating synergies with CMS's existing products in terms of expert networks and market resources, ultimately benefiting patients at the earliest opportunity.

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