SK Bioscience Receives US Approval for Phase 3 Clinical Trial of 21-Valent Pneumococcal Protein-Conjugate Vaccine

"A Very Important Advancement in the Development of GBP410"

SK Bioscience has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 3 clinical trial plan of the 21-valent pneumococcal vaccine (GBP410) in the United States.

According to the disclosure on the 17th, the clinical trials are divided into phases 1 to 4. Phase 1 is a trial evaluating immunogenicity and safety by administering the vaccine four times to 1,630 healthy infants and children.

Phase 2 conducts a similar trial on 2,320 subjects, and Phase 4 is a catch-up vaccination trial adjusting the number of doses according to age, conducted on 1,252 subjects. Phase 3 details have not been disclosed.

This clinical trial is part of the global Phase 3 trial being conducted with Sanofi. The global trial, recruiting 7,700 participants worldwide, began dosing the first subject last month.

Ahn Jae-yong, President of SK Bioscience, stated, "The FDA's completion of the review for the Phase 3 trial plan is a very important advancement in the development of GBP410. We will do our best to address unmet medical needs and provide safe and effective protection to more people through GBP410 and innovative next-generation pneumococcal vaccines with 21 or more valences that will be developed in the future."

This content was produced with the assistance of AI translation services.