冻干人用狂犬病疫苗(无血清Vero细胞)
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科兴吸附破伤风疫苗获药品注册批件
Jing Ji Wang· 2025-08-27 08:21
Group 1 - The core viewpoint of the news is that Beijing Kexing Holdings' subsidiary has developed an adsorbed tetanus vaccine, which has received approval from the National Medical Products Administration, providing more options for tetanus prevention [1] - The Kexing adsorbed tetanus vaccine utilizes nanometer-level adjuvant technology and purification process innovations, achieving breakthroughs in immunogenicity and safety, thus offering a superior solution for tetanus prevention [1] - The vaccine features an adjuvant with a particle size of only 300 nanometers, significantly enhancing the adsorption efficiency of the antigen and improving the stability of the formulation compared to traditional adjuvants [1] Group 2 - The phase III clinical study of the Kexing adsorbed tetanus vaccine shows that the geometric mean concentration (GMC) of antibodies is higher than that of the control vaccine, indicating good safety [1] - Tetanus remains a serious public health issue in countries and regions with inadequate immunization programs, with an estimated annual incidence of approximately 1 million cases and a death toll of 300,000 to 500,000 [1] - The vaccine is intended for post-exposure prevention of tetanus in cases of injury and for pre-exposure prevention in high-risk populations [1] Group 3 - Kexing Group is actively expanding its presence in the injury field, with the adsorbed tetanus vaccine being a key product in the company's "injury combination product" strategy [2] - In addition to the vaccine, the company is advancing clinical research on the anti-tetanus toxin monoclonal antibody SNA02-48 injection [2] - The company has also invested in Xingmeng Biotech, which developed the innovative drug Kexib, approved for passive immunotherapy for adult rabies virus exposure in 2024 [2]