CANSINOBIO (06185) has announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its acellular component pertussis, tetanus, and diphtheria combined vaccine (DTcP) for infants and young children under the age of two. The vaccine, branded as Pan Kang Xin®, is the first component-based DTaP vaccine to be marketed in China.

Currently, the co-purified DTaP vaccines available in the domestic market are manufactured using a co-purification process for the pertussis antigens. In contrast, CANSINOBIO's infant DTcP vaccine is a component-based vaccine, where each pertussis antigen is individually purified and then formulated in a precise ratio. This method ensures consistent quality between production batches and results in a more stable product.

The development of the infant DTcP vaccine lays the foundation for the future development of an acellular component pertussis, tetanus, and diphtheria combined vaccine for individuals aged six years and above, as well as other combination vaccines based on the DTcP platform.

This approval represents the first product in CANSINOBIO's component DTaP vaccine portfolio to receive NDA approval. The company has accumulated valuable experience in clinical research, quality control, and large-scale production, which is expected to facilitate the commercialization of other candidate vaccines in its pipeline.

Furthermore, the launch of the infant DTcP vaccine will enrich and optimize CANSINOBIO's commercial product portfolio, helping to enhance the company's brand recognition in the market.