GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea

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

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.

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

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo^® (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/

This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma’s management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.

GC Biopharma Contacts (Media)
Sohee Kim
shkim20@gccorp.com

Yelin Jun
yelin@gccorp.com

Yoonjae Na
yjy6520@gccorp.com

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SOURCE GC Biopharma