GC Biopharma announced that Ministry of Food and Drug Safety (MFDS) in South Korea has approved the Investigational New Drug (IND) application for the phase I clinical trial of GC4006A, mRNA (messenger RNA) vaccine candidate for COVID-19.

Following the IND submission in September, the approval was granted in a short timeframe. The company expects to accelerate development in alignment with the Korean government's policy initiative to localise mRNA vaccine. The company plans to submit phase II IND in the second half of 2026.

GC4006A is a COVID-19 vaccine candidate developed using GC Biopharma's proprietary mRNA-LNP (Lipid Nanoparticle) platform. mRNA vaccines are regarded as a critical technology that extends beyond a single infectious disease, as they enable rapid responses to emerging pathogens and viral variants in future pandemics.

"This IND approval represents a meaningful milestone, demonstrating the robustness and competitiveness of our mRNA platform. We will continue to explore the applicability of the platform technology across various therapeutic areas, including vaccines," said Jaewoo Lee, Head, Regulatory Science and Product Development Division, GC Biopharma.

Meanwhile, the company was recently selected as a recipient of phase I clinical research support under the Korea Disease Control and Prevention Agency (KDCA)'s 'mRNA Vaccine Development Support Project for Pandemic Preparedness.'

GC Biopharma's mRNA-LNP platform enhances both the level and durability of protein expression by applying its proprietary UTR patents, codon optimisation technology and LNP with advanced delivery efficiency. It is the first company in Korea to independently execute the entire process of mRNA vaccines from candidate discovery to manufacturing and production.