Recently, CanSinoBio's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as "PCV13i") has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population.

CanSinoBio's PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory.

At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines.

In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal origin, which reduces the risk caused by biological factors of animal origin, and avoids the toxic residues caused by the traditional purification process using the phenol method.

The achievement of this clinical trial summary report indicates that PCV13i has the necessary conditions to submit the application for drug manufacturing registration to the National Drug Administration (NMPA), after which it still needs to go through the procedures of technical review, clinical trial site verification, production site inspection, etc., and can be marketed only after obtaining the approval of the registration of the drug and the approval of the issuance of the product.

https://mp.weixin.qq.com/s/kI4i0jjU-R1T3h7bR6V5rQ