GC Biopharma receives approval for elderly influenza vaccine trials

GC Biopharma has received approval from the Ministry of Food and Drug Safety to proceed with Phase 2/3 clinical trials for its high-immunogenicity influenza vaccine candidate, ‘GC3114B’. The trials will focus on evaluating the immunogenicity and safety of the vaccine in individuals aged 65 and older through direct comparison with an active control group.

Designed to induce a stronger immune response than standard-dose vaccines, GC3114B contains a higher antigen content to combat the diminished immune function often seen in elderly populations. The company plans to begin the first patient dosing for Phase 2 in the second half of this year, with Phase 3 trials intended to be conducted across multiple countries.

GC Biopharma aims to secure domestic self-sufficiency for high-immunogenicity vaccines, which currently rely heavily on imports, and seeks to enter the National Immunization Program (NIP) market. The company has also established a manufacturing and supply chain strategy through a partnership with Korea Vaccine to utilize pre-filled syringe production facilities.