GC Biopharma 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.
The development of GC4006A has progressed rapidly since April 2025, when the Korea Disease Control and Prevention Agency (KDCA) selected GC Biopharma to lead the agency's "the mRNA Vaccine Development Support Project for Pandemic Preparedness". With the KDCA's goal of localizing mRNA vaccine production by 2028, GC Biopharma is committing its full resources and expertise to the project, the company stated.
In the Phase 1 clinical trial, GC Biopharma plans to evaluate the safety and immunogenicity of its vaccine candidate, GC4006A, in healthy adult volunteers. If the Investigational New Drug (IND) application is approved by the end of 2025 as expected, the company will initiate the first administrations in early 2026.
In a previously conducted non-clinical study, GC4006A 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.
GC4006A is the key product of the mRNA-LNP(Lipid Nanoparticle) platform that the company has developed through its mRNA-LNP research since 2019. This platform enables the company to manage the entire mRNA vaccine development process end-to-end. The upcoming Phase 1 clinical trial will serve as a testing ground to demonstrate the platform's capabilities, paving the way for a rapid response to future pandemics within 100 days of an outbreak.
"GC Biopharma is the first company in Korea to establish a full in-house capacity of mRNA drug development from start to finish", said Jae Uk Jeong, Head of R&D at GC Biopharma. "The development of our COVID-19 mRNA vaccine marks just the beginning. We are committed to expanding the platform's applications to a wide range of diseases."
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