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GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea
GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced today 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.
About this update from Gc Biopharma Corp.
[{"type":"text","content":"- Phase 2 IND submission targeted for the second half of 2026- Demonstrating the competitiveness of GC Biopharma's mRNA platform ","length":133,"tagName":"p","attribs":{}},{"type":"text","content":"YONGIN, South Korea, Dec. 22, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced today 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.","length":369,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/GC Biopharma)","displaySize":"","headline":null,"caption":"(PRNewsfoto/GC Biopharma)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/4b834899abdf3d99fcde8560d438cc9a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/B0c2J77qVeMlBCJvcjoKKg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/4b834899abdf3d99fcde8560d438cc9a","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/1888566/GC_Biopharma_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":294,"tagName":"p"},{"type":"text","content":"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.","length":320,"tagName":"p"},{"type":"text","content":"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'.","length":242,"tagName":"p"},{"type":"text","content":""This IND approval represents a meaningful milestone, demonstrating the robustnes...