GC Biopharma, a leading global biopharmaceutical company, announced that South Korea’s Ministry of Food and Drug Safety has approved its Investigational New Drug application for a Phase 1 clinical trial of GC4006A, its mRNA vaccine candidate for COVID-19. The approval comes shortly after the IND submission in September, allowing the company to accelerate its development plans in line with the Korean government’s initiative to localize mRNA vaccine production. GC Biopharma aims to file for Phase 2 IND approval in the second half of 2026.

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GC4006A is developed using GC Biopharma’s proprietary mRNA-LNP platform, which combines messenger RNA with lipid nanoparticles to enhance delivery and protein expression. mRNA vaccine technology is considered a key tool not only for COVID-19 but also for rapid responses to emerging infectious diseases and potential viral variants in future pandemics. The platform allows for flexible and speedy development of vaccines against new pathogens.

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In addition, GC Biopharma was recently selected to receive Phase 1 clinical research support under the Korea Disease Control and Prevention Agency’s mRNA Vaccine Development Support Project for Pandemic Preparedness. This selection underscores the company’s leading role in advancing mRNA technology in Korea.

Jaewoo Lee, Head of the Regulatory Science and Product Development Division at GC Biopharma, stated that the IND approval is an important milestone, highlighting the strength and competitiveness of the company’s mRNA platform. He emphasized that GC Biopharma will continue to explore the platform’s potential across multiple therapeutic areas, including vaccines.

The mRNA-LNP platform developed by GC Biopharma applies proprietary UTR patents, codon optimization technology, and advanced lipid nanoparticle delivery systems to enhance both protein expression levels and durability. The company is the first in Korea to independently manage the entire process of mRNA vaccine development from candidate discovery to manufacturing and production, demonstrating its capability to lead innovation in the field.

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