SK bioscience wins China approval for GBP410 clinical trials

(SK bioscience)

SK bioscience Co. said on Friday it received approval from Chinese medical regulators to begin phase 1 and phase 3 clinical trials of its 21-valent pneumococcal conjugate vaccine candidate, GBP410.

The vaccine, developed in partnership with France’s Sanofi, demonstrated comparable immunogenicity and safety to existing approved vaccines in a global phase 2 trial, the company said in a statement. Phase 3 trials are underway in multiple countries.

China requires local clinical data for vaccine approvals, and SK bioscience said it plans to swiftly complete phase 1 testing in the country before moving to phase 3 trials.

GBP410 is the first pediatric pneumococcal vaccine candidate in phase 3 trials to cover more than 20 serotypes, the company added. The phase 3 will be conducted in infants and toddlers in China.