CanSino Biologics Inc. announced that 13-Valent pneumococcal conjugate vaccine (CRM197, TT Vector) (the "PCV13i ") developed by the Company has obtained the final report of Phase III clinical trial recently. ItsPCV13i adopts a covalent combination of polysaccharide antigens and carrier proteins. After the polysaccharide antigens are linked to the carrier proteins, the polysaccharide can be converted into T cells dependent antigens, which not only induces a high level of specific antibodies in infants and young children under 2 years old, but also generates memory B cells to produce immune memory.

Meanwhile, the Company adopts double vector technology which can reduce the immunosuppression to immunogenicity when co-injecting with other vaccines. In terms of production technology, the Company has adopted a safer production process, with animal-free culture medium as the fermentation medium, reducing risks from animal-derived biological factors and avoiding the toxicity residue from traditional purification process by phenol method. The final report of Phase III clinical trial of PCV13i shows that PCV13i has a favorable safety and immunogenicity profile, and the clinical study has reached its pre-determined clinical conclusion in the target population based on the data available to date.

The obtaining of the final report of the clinical trial demonstrates that PCV13i possesses the necessary conditions for submitting the NDA to the National Medical Products Administration (NMPA), after which it shall be subject to the procedures of technical evaluation, clinical trial onsite inspection and production site inspection, and will be commercialized only after obtaining the NDA approval and lot release approval.