GC Biopharma seeks approval for COVID-19 mRNA vaccine trial in Korea

YONGIN, South Korea - GC Biopharma (KS:006280), a prominent player in the Biotechnology industry and consistently profitable over the last twelve months according to InvestingPro data, has submitted an Investigational New Drug application to South Korea’s Ministry of Food and Drug Safety for a Phase 1 clinical trial of its COVID-19 mRNA vaccine candidate, GC4006A.

The company plans to evaluate the safety and immunogenicity of the vaccine in healthy adult volunteers. If approved by the end of 2025, the first administrations would begin in early 2026. With net income expected to grow this year, GC Biopharma appears well-positioned to fund its clinical development programs.

The development has accelerated since April 2025, when the Korea Disease Control and Prevention Agency selected GC Biopharma to lead its "mRNA Vaccine Development Support Project for Pandemic Preparedness," which aims to localize mRNA vaccine production by 2028. The company’s strong financial foundation, including a 20-year track record of consistent dividend payments, underscores its stability in pursuing long-term projects.

According to the company, pre-clinical studies showed GC4006A generated antibody levels comparable to existing vaccines while demonstrating a strong cellular immune response against infected cells.

The vaccine is developed using GC Biopharma’s mRNA-LNP (Lipid Nanoparticle) platform, which the company has researched since 2019. This platform enables end-to-end management of the mRNA vaccine development process.

"GC Biopharma is the first company in Korea to establish a full in-house capacity of mRNA drug development from start to finish," said Jae Uk Jeong, Head of R&D at GC Biopharma, in a press release statement.

The company plans to expand applications of its mRNA-LNP platform beyond COVID-19 to include rare genetic diseases, chronic inflammatory diseases, anticancer immunotherapies, and other vaccines. For detailed financial analysis and additional insights about GC Biopharma’s growth potential, visit InvestingPro, where you’ll find 5 more exclusive ProTips and comprehensive metrics.

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