GC Biopharma Moves Ahead with Phase 1 Trial for COVID-19 mRNA Vaccine

GC Biopharma Advances COVID-19 Vaccine Development in South Korea

GC Biopharma, one of the prominent pharmaceutical players in South Korea, has taken a significant step towards combating the COVID-19 pandemic by submitting an Investigational New Drug (IND) application to the country's Ministry of Food and Drug Safety (MFDS). This request pertains to the Phase 1 clinical trial of its mRNA vaccine candidate known as GC4006A, marking a critical milestone in the clinical exploration of mRNA technology for COVID-19 prevention.

The journey for GC4006A began in April 2025 when the Korea Disease Control and Prevention Agency (KDCA) chose to partner with GC Biopharma for the important mRNA Vaccine Development Support Project aimed at pandemic preparedness. The agency’s ambitious goal is to localize mRNA vaccine production by the year 2028, and GC Biopharma is putting forth its full expertise and resources towards meeting this target.

As outlined in their trial plans, GC Biopharma intends to focus on evaluating both the safety and immunogenicity of GC4006A in a cohort of healthy adult volunteers. If the IND application receives approval as expected by the end of 2025, the company is poised to commence the first vaccinations in early 2026. This timeline suggests a targeted and efficient approach to vaccine development, reflecting the urgency associated with pandemic response measures.

Prior studies conducted prior to this IND submission demonstrated that GC4006A induced a strong humoral immune response, resulting in antibody levels that are comparable to those seen with existing COVID-19 vaccines. Additionally, it showed an impressive cellular immune response that effectively targets infected cells, signaling potential efficacy in real-world applications.

GC4006A derives from an innovative mRNA-LNP (Lipid Nanoparticle) platform that GC Biopharma has been refining since 2019. This robust platform enables them to control and streamline the mRNA vaccine development process from inception to completion. The Phase 1 clinical trial will serve as a key opportunity to validate the platform’s capabilities and readiness to respond rapidly to future public health challenges arising from emerging infectious diseases.

Jae Uk Jeong, the Head of Research and Development at GC Biopharma, emphasized the importance of this project by stating, “GC Biopharma is the first company in Korea to establish a full in-house capacity of mRNA drug development from start to finish.