According to the Zhitong Finance App, Cansino Biotech (06185) issued an announcement that the China National Drug Administration (NDA) has approved the new drug marketing application (NDA) for the adsorbed tetanus vaccine (tetanus vaccine) developed by the company.
Tetanus is an acute infectious disease caused by tetanus bacillus tetanus infecting the body. An exotoxin produced by tetanus bacillus, is a tetanus spasmodic toxin, a causative agent of tetanus and can cause skeletal muscle tonic contraction and paroxysmal spasms throughout the body. Severe tetanus patients can be complicated by laryngospasm, asphyxia, lung infection, and organ failure. The case fatality rate is as high as 30% to 50%, and the case fatality rate is close to 100% without medical intervention. It is an extremely serious potentially fatal disease.
The tetanus vaccine developed by our company is fermented using animal-free medium, which is safer, has determined a large-scale industrialized process, and the process is stable. This vaccine is mainly used to prevent non-neonatal tetanus. It will enrich the company's product pipeline and enhance the company's core competitiveness. According to phase III clinical data of our tetanus vaccine, the test vaccine can cause an ideal immune response. The antibody GMC (Geometric Mean Concentration) is superior to the control vaccine 30 days after exemption. It has a clear advantage over the control group, indicating that the test vaccine had good immunogenicity in the test population.
The launch of this product will enrich the variety of our commercial products and expand the adult vaccine market. The company has reached an exclusive commercialization cooperation agreement with Yuanda Life Sciences Group Co., Ltd. for the tetanus vaccine. According to the agreement, the company will authorize Yuanda Life Sciences Group Co., Ltd. to carry out exclusive promotion services in Greater China for the tetanus vaccine developed by the company after the product is approved, to further expand vaccine accessibility.