China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its DTcP vaccine, designed for infants and young children under the age of 2.
Quality Consistency and Market Gap
The DTcP vaccine, a component pertussis vaccine, is noted for its quality consistency between batches, ensuring a more stable product quality. This is significant as there is no similar domestically produced product currently available in the Chinese market.
Phase III Clinical Study and Immunization Schedule
According to the Phase III clinical study, the primary immunization with this vaccine begins at 2 months of age and requires a total of 3 doses, with an interval of 1 or 2 months between each dose. A booster immunization is administered between 18 and 24 months of age, with each individual receiving 1 dose.-Fineline Info & Tech
