CanSinoBIO's NDA for Td5cp Adolescent and Adult Accepted, Further Strengthening Its Diversified Vaccine Pipeline

HONG KONG, August 16, 2026 - (ACN Newswire) - On August 16, 2026, CanSino Biologics Inc. ("CanSinoBIO"; HKEX: 06185/SHSE: 688185) announced that the New Drug Application (NDA) for its Tetanus, Reduced Diphtheria and Pertussis (Acellular, Five Components) Combined Vaccine, Adsorbed (for people aged six years and above; the "Td5cp Adolescent and Adult") has been formally accepted by China's National Medical Products Administration (NMPA). As a booster vaccine for adolescents and adults, the product was granted Priority Review status in May 2026. If approved and launched, it is expected to create synergies with the recently approved next-generation three-component DTaP vaccine Tripecia(R) (DT3cP Infant), further strengthening CanSinoBIO's pertussis-containing vaccine portfolio across different age groups.

Pertussis is a highly contagious acute respiratory infectious disease caused by Bordetella pertussis¹. In recent years, the disease has experienced a global resurgence. Data show that reported pertussis cases in China exceeded 470,000 in 2024¹, representing an approximately 12-fold increase compared with 2023 and drawing sustained attention to disease prevention and control. Against this backdrop, in addition to primary immunization in infants, the importance of booster immunization during adolescence and adulthood has become increasingly evident. Vaccination with diphtheria, tetanus and pertussis-containing vaccines is an important measure for preventing the related diseases, yet China has long lacked a dedicated booster immunization product for people aged six years and above.

In April this year, CanSinoBIO's Diphtheria, Tetanus and Pertussis (Acellular, Three Components) Combined Vaccine, Adsorbed for infants—Tripecia(R) (DT3cP Infant)—was approved for marketing through the NMPA's Priority Review pathway, marking an important breakthrough for the company in component-based pertussis vaccine technology. Compared with the three-component (PT, FHA and PRN) DT3cP vaccine, the Td5cp Adolescent and Adult includes two additional pertussis antigens, FIM2 and FIM3. Each pertussis antigen is individually purified and formulated at precise ratios, helping ensure stable product quality and batch-to-batch consistency. The continued advancement of this product will also support further exploration of innovative component-based pertussis vaccine technology across broader age groups.

In July 2026, seven departments, including the National Disease Control and Prevention Administration and the National Development and Reform Commission, jointly issued the "15th Five-Year Plan for Disease Prevention and Control", which explicitly calls for the implementation of a life-course immunization strategy covering the entire population. As public health needs continue to evolve, providing more comprehensive immunization protection solutions for people at different stages of life has become an important direction for vaccine innovation. If the Td5cp Adolescent and Adult is successfully approved and launched, it will further enrich CanSinoBIO's pertussis-containing vaccine portfolio and support the company's continued efforts to strengthen its innovative vaccine portfolio across all age groups.

From a capital market perspective, the acceptance of the NDA for the Td5cp Adolescent and Adult marks the product's formal entry into a key regulatory review stage. It also represents important progress in CanSinoBIO's continued advancement of innovative vaccine R&D and commercialization, while strengthening market expectations for the development of the company's pipeline of combination vaccine candidates and laying a solid foundation for the company's medium- to long-term performance growth.

References:

1. Chinese Center for Disease Control and Prevention: https://www.chinacdc.cn/jkyj/mygh02/jbzt/xjxcrb/brk/202409/t20240925_300997.html

2. Zhang W, Wei C, Wan P, et al. Safety and immunogenicity of diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed after three-dose priming in 2 months age infants: a randomized, blinded, controlled phase III clinical trial in China. Emerg Microbes Infect. 2026 Feb;15(1):2625556.

3. Dai H, Sui X, Che J, et al. Pathogenicity and vaccine protection of circulating pertactin- and filamentous hemagglutinin-deficient Bordetella pertussis strains. Emerg Microbes Infect. 2026 Feb;15(1):2640283.

4. CSR data on file