Core Viewpoint - China Medical System Holdings Limited (CMS) has entered into exclusive collaboration agreements with Chongqing Genrix Biopharmaceutical Co., Ltd. for two Class 1 therapeutic biological products, Vecantoxatug and Silevimig, aimed at passive immunization against tetanus and rabies, respectively. The agreements grant CMS exclusive commercialization rights in mainland China and licensing rights in the Asia-Pacific region, the Middle East, and North Africa, with a term extending up to ten years post-marketing approval [1][4]. Group 1: Vecantoxatug - Vecantoxatug is a passive immunization agent that has shown superior protection compared to human tetanus immunoglobulin (HTIG) and has successfully met its primary efficacy endpoint in Phase III clinical trials [2][4]. - The product was designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) in May 2024, and its New Drug Application (NDA) was accepted on May 22, 2025 [2]. - Vecantoxatug is a recombinant humanized monoclonal antibody that effectively blocks tetanus neurotoxin entry into neurons, providing a safer and more effective option for passive immunization [5][7]. Group 2: Silevimig - Silevimig is the world's first recombinant, fully human bispecific antibody against rabies virus, developed to target specific antigenic sites as recommended by the World Health Organization (WHO) [3][9]. - The NDA for Silevimig was accepted by the CDE on January 14, 2025, and a clinical trial application for use in children and adolescents was approved in July 2025 [3][10]. - In Phase III clinical trials, Silevimig demonstrated non-inferior protective efficacy compared to human rabies immunoglobulin (HRIG), providing immediate protection without compromising the active immune response from vaccination [10][12]. Group 3: Market Context and Clinical Need - The market for passive immunization against tetanus and rabies is significant, with existing products facing safety and accessibility issues, highlighting the need for innovative solutions like Vecantoxatug and Silevimig [4][11]. - Tetanus has a high global mortality rate, with 500,000 to 1,000,000 cases reported annually, while rabies has a near 100% case-fatality rate once symptoms appear, emphasizing the urgent need for effective preventive measures [6][11]. - Current passive immunization options in China, such as HRIG and equine rabies antiserum, have limitations including high costs and potential adverse reactions, creating a market opportunity for the new products [12].
China Medical System (867.HK; 8A8.SG) Signed Collaboration Agreements for Two Innovative Biologics Used for Passive Immunization Against Tetanus and Rabies