Phase 2 IND submission targeted for the second half of 2026
- Demonstrating the competitiveness of GC Biopharma's mRNA platform  

GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced that Ministry of Food and Drug Safety (MFDS) in South Korea has approved the Investigational New Drug (IND) application for the Phase 1 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 localize mRNA vaccine. GC Biopharma plans to submit Phase 2 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.

Meanwhile, GC Biopharma was recently selected as a recipient of Phase 1 clinical research support under the Korea Disease Control and Prevention Agency (KDCA)'s 'mRNA Vaccine Development Support Project for Pandemic Preparedness'.

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

GC Biopharma's mRNA-LNP platform enhances both the level and durability of protein expression by applying its proprietary UTR¹⁾ patents, codon²⁾ optimization technology, and LNP with advanced delivery efficiency. GC Biopharma is the first company in Korea to independently execute the entire process of mRNA vaccines from candidate discovery to manufacturing and production.

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1) Untranslated Region, Regions positioned before and after the codon that play a role in controlling mRNA stability and protein expression

2) The portion of mRNA to produce proteins