CANSINOBIO (06185.HK): Tetanus Vaccine Receives NMPA New Drug Application Approval, Expanding Adult Vaccine Market

NewTimeSpace News: On 20 August 2026, CANSINOBIO (06185.HK) announced that its adsorbed tetanus vaccine received NMPA new drug application approval; Phase III data showed antibody GMC at 30 days post-immunization superior to the comparator vaccine, and an exclusive commercialization cooperation has been reached with Grand Life Sciences for Greater China.

NewTimeSpace News: On 20 August 2026, CanSino Biologics Inc. (stock code: 06185) published an inside information announcement under Rule 13.09 of the Listing Rules and Part XIVA of the Securities and Futures Ordinance, stating that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for the company's self-developed adsorbed tetanus vaccine (the tetanus vaccine).

Tetanus is an acute infectious disease caused by infection with Clostridium tetani; tetanospasmin, an exotoxin produced by the bacterium, causes tonic contraction of skeletal muscles and paroxysmal spasms. Severe cases may be complicated by laryngospasm, asphyxia, pulmonary infection and organ failure, with a case fatality rate as high as 30% to 50%, approaching nearly 100% without medical intervention. The company's tetanus vaccine, developed using animal-component-free culture media, is safer with a stable industrialized process, and is mainly used for the prevention of non-neonatal tetanus. Phase III clinical data showed that the geometric mean concentration (GMC) of antibodies at 30 days after immunization was superior to the comparator vaccine, demonstrating good immunogenicity in the trial population.

The approval will enrich the company's commercialized product portfolio and expand the adult vaccine market. The company has entered into an exclusive commercialization cooperation agreement with Grand Life Sciences Group Co., Ltd. for the tetanus vaccine, under which the company will grant it exclusive promotion services in Greater China following product approval, further enhancing vaccine accessibility.

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