Health

Sinovac absorption tetanus vaccine obtained drug registration approval

2025-08-26   

On August 25th, the adsorbed tetanus vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd., a subsidiary of Beijing Kexing Holdings (Group) Co., Ltd., obtained the "Drug Registration Approval" (Approval No.: National Medical Products Administration Approval No. S20250048) from the National Medical Products Administration, which will provide more choices for the prevention of tetanus. The Sinovac adsorption tetanus vaccine achieves a dual breakthrough in immunogenicity and safety through innovative nanoscale adjuvant technology and purification processes, providing a better solution for tetanus prevention. The vaccine uses aluminum hydroxide adjuvant with a particle size of only 300 nanometers (traditional adjuvants are 1-10 microns) to improve antigen adsorption efficiency and significantly enhance formulation stability. By upgrading the purification process, the tetanus vaccine raw material has better immunogenicity. The Phase III clinical study of Sinovac adsorption tetanus vaccine showed that the geometric mean concentration (GMC) of antibodies was higher than that of the control vaccine, indicating good safety. According to the "Diagnosis and Treatment Standards for Non Neonatal Tetanus (2024 Edition)", tetanus remains a serious public health problem in countries and regions where immunization programs are not implemented effectively. It is estimated that there are approximately 1 million cases of tetanus worldwide each year, with 300000 to 500000 deaths. The tetanus vaccine can be used for the management of tetanus prevention after trauma and for pre exposure prevention of potential high-risk populations for trauma. Non neonatal tetanus refers to an acute, specific, and toxic disease characterized by sustained tetanic contractions and paroxysmal spasms of skeletal muscles throughout the body, caused by the invasion of Clostridium tetani through skin or mucosal rupture, reproduction in an anaerobic environment, and the production of exotoxins. Severe patients can experience laryngeal spasms, asphyxia, lung infections, and organ failure. Without medical intervention, the mortality rate is close to 100%. Even with active comprehensive treatment, the global mortality rate is still 30% to 50%, making it an extremely serious and potentially fatal disease. In recent years, Sinovac Group has actively expanded its presence in the field of trauma, and the adsorption tetanus vaccine is an important product in the company's "trauma combination product" strategy. In addition to vaccines, the company is advancing clinical research on the injection of anti tetanus toxin monoclonal antibody SNA02-48. In addition, the Class 1 innovative drug Kribi developed by Xingmeng Biotechnology, which the company invested in, has been approved for market in 2024 for passive immunotherapy of adult rabies virus exposed individuals; The market application for the freeze-dried human rabies vaccine (serum-free Vero cells) developed by Sinovac Biotech (Chengdu) Co., Ltd. has also been accepted in January 2025. Sinovac Group is committed to meeting the unmet clinical needs in the field of disease prevention and control, and will promote the launch of more innovative vaccines and monoclonal antibody products to provide more protection for human health. (New Society)

Edit:GUAN LUCIANA Responsible editor:Zhang Lin

Source:Xinhua Net

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