CANSINOBIO (06185): The DTcP vaccine for infants and young children has been approved by the Chinese National Medical Products Administration (NMPA).

CANSINOBIO (06185) announced that the China National Medical Products Administration has approved the company's research and development of a new drug application (NDA) for the infant and toddler adsorbed acellular pertussis (three-component) diphtheria-tetanus-pertussis combination vaccine (DTcP) (under 2 years old) (infant and toddler DTcP, trade name: Pankangxin). It is reported that the manufacturing process of the acellular pertussis vaccine currently on sale in China uses a co-purification process for the pertussis antigen, while the company's infant and toddler DTcP is a three-component acellular pertussis vaccine, where each pertussis antigen can be purified individually and formulated in a predetermined ratio to ensure consistency in product quality between batches and make the product more stable. The company's infant and toddler DTcP is the first domestically marketed three-component acellular pertussis vaccine. The development of the infant and toddler DTcP lays the foundation for further development of adsorbed acellular pertussis (component) diphtheria-tetanus-pertussis combination vaccine (for those aged six and above) and combination vaccines based on DTcP. The company's infant and toddler DTcP is the first product in the company's portfolio of three-component acellular pertussis vaccine combinations to receive NDA approval. The company has accumulated relevant experience in clinical research and development, quality control, and large-scale production, which will facilitate the progress of other candidate vaccines in the product portfolio towards market approval. Additionally, the launch of the infant and toddler DTcP will enrich and optimize the company's commercial product structure, enhancing the brand effect of the company at the terminal.