South Korea-based pharmaceutical company GC Biopharma (KS:006280) announced on Monday that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) in South Korea for a Phase 1 clinical trial of GC4006A, its mRNA (messenger RNA) vaccine candidate for COVID-19.

In the Phase 1 trial, GC Biopharma plans to evaluate the safety and immunogenicity of GC4006A in healthy adult volunteers. In an earlier non-clinical study, the vaccine candidate demonstrated a robust humoral immune response, generating antibody levels comparable to those of existing vaccines. The vaccine also elicited a strong cellular immune response, effectively targeting infected cells.

GC Biopharma was selected by the Korea Disease Control and Prevention Agency (KDCA) in April 2025 to lead the agency's mRNA Vaccine Development Support Project for Pandemic Preparedness.

The company said that it is committing its full resources and expertise to the project, with the KDCA's aim of localising mRNA vaccine production by 2028.