CanSinoBIO advances Td5cp booster candidate into key stage of NMPA review

CHINA—CanSino Biologics Inc. has announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for a five-component tetanus, reduced diphtheria, and pertussis (Td5cp) combined vaccine for people aged six years and above.

The vaccine, known as Td5cp Adolescent and Adult, is being developed as a booster for adolescents and adults.

The NMPA granted the candidate Priority Review status in May 2026.

If approved and launched, the vaccine will complement CanSinoBIO’s recently approved three-component DTaP vaccine, Tripecia® (DT3cP Infant), expanding the company’s pertussis-containing vaccine portfolio across age groups.

Addressing the pertussis burden

Pertussis is a highly contagious respiratory disease caused by Bordetella pertussis.

Reported cases have increased sharply in several countries in recent years, including China, where more than 470,000 cases were reported in 2024.

This represented an approximately 12-fold increase from 2023 and has heightened attention to disease prevention and control.

While infant vaccination remains an important part of pertussis prevention, booster immunisation during adolescence and adulthood is also gaining importance.

Vaccines containing diphtheria, tetanus and pertussis components can provide protection against these diseases.

However, China has historically lacked a dedicated pertussis booster product specifically targeting people aged six years and above.

Five-component vaccine technology

CanSinoBIO’s latest vaccine builds on the company’s work in component-based pertussis vaccine development.

In April 2026, the NMPA approved Tripecia® (DT3cP Infant), a three-component diphtheria, tetanus and pertussis vaccine for infants, through its Priority Review pathway.

The three-component vaccine contains the pertussis antigens pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN).

In comparison, the Td5cp Adolescent and Adult adds fimbrial antigens FIM2 and FIM3, bringing the total number of pertussis components to five.

CanSinoBIO said each pertussis antigen undergoes individual purification before being formulated at specified ratios.

The approach is intended to support consistent product quality and manufacturing performance between batches.

Development of the vaccine will also allow the company to further investigate component-based pertussis vaccine technology for use across additional age groups.

Supporting life-course immunisation

In July 2026, seven government 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.

The plan calls for a life-course immunisation strategy covering the population across different life stages.

Against this policy backdrop, vaccine developers are exploring products that address immunisation needs beyond childhood.

If approved and commercialised, CanSinoBIO’s Td5cp Adolescent and Adult would add a booster option for older age groups to the company’s existing pertussis vaccine portfolio.

The NDA acceptance also moves the vaccine into a key stage of regulatory review as CanSinoBIO advances its combination vaccine pipeline and broader development and commercialisation efforts. 

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