CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study

CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bivalent COVID-19 mRNA vaccine SYS6006.32, targeting the XBB.1.5 and BQ.1 variants.

Vaccine Development and Immunogenicity
SYS6006.32 is developed based on CSPC’s first-generation COVID-19 mRNA vaccine, DuEnTai. Non-clinical research data indicates that SYS6006.32 exhibits very high immunogenicity against mainstream variants such as EG.5 and XBB.1.5, with live virus neutralizing antibody levels 108 and 88 times higher than those observed with DuEnTai, respectively.

Broad-Spectrum Immune Activity and Safety Profile
In addition to its high efficacy against specific variants, SYS6006.32 also demonstrates broad-spectrum cross-immune activity against a range of variants, including XBB.1.16, XBB.1.9, BA.5, BQ.1, and BA.2.86. Regarding safety, the vaccine does not introduce any new risks compared to its predecessor, DuEnTai, ensuring a favorable safety profile for the new bivalent formulation.-Fineline Info & Tech

Fineline Info & Tech