#South Korea #GC Biopharma #Yongin #COVID-19 #mRNA Vaccine

GC Biopharma Achieves IND Approval for COVID-19 mRNA Vaccine

GC Biopharma, a notable global biopharmaceutical firm based in South Korea, has recently celebrated a pivotal milestone with the sanctioned IND (Investigational New Drug) approval. The country's Ministry of Food and Drug Safety has authorized the initiation of a Phase 1 clinical trial for their innovative mRNA vaccine, designated as GC4006A, aimed at combating COVID-19.

The approval came swiftly following the IND submission made by GC Biopharma in September of this year. This rapid endorsement aligns seamlessly with the South Korean government's strategic push to localize mRNA vaccine production, reinforcing the nation's commitment to enhancing its pandemic preparedness. The company is setting its sights on submitting a Phase 2 IND application by the latter half of 2026, reflecting its ambition to advance further in mRNA vaccine development.

GC4006A leverages the proprietary mRNA-LNP (Lipid Nanoparticle) technology, which GC Biopharma has developed. This platform is heralded for its versatility in governing responses to not just COVID-19 but also future viral threats and variants that may arise. The mRNA technology is increasingly recognized as a cornerstone in modern vaccine development, allowing for swift and effective responses to emerging infectious diseases.

In conjunction with this IND approval, GC Biopharma has recently been acknowledged as part of the Phase 1 clinical research support by the Korea Disease Control and Prevention Agency (KDCA). This recognition is part of an initiative focused on mRNA vaccine development meant to bolster the country’s response to future pandemics.

Jaewoo Lee, the head of Regulatory Science and Product Development Division at GC Biopharma, expressed that securing this IND approval signifies a robust validation of their mRNA platform's capabilities. He affirmed the company's ongoing commitment to explore the varying therapeutic applications of this pioneering technology across diverse medical fields, particularly in vaccine development.

Furthermore, GC Biopharma's mRNA-LNP platform offers a significant enhancement in both the efficacy and longevity of protein expression. Equipped with cutting-edge technologies including their proprietary UTR (Untranslated Region) patents and codon optimization systems, the company excels in the delivery of mRNA vaccines, with ambitions of being a trailblazer in this crucial domain.

GC Biopharma stands as the only company in South Korea to actively manage the full spectrum of mRNA vaccine creation, encompassing everything from initial candidate discovery to manufacturing and production. This comprehensive approach not only positions the company as a leader in the biopharmaceutical sector but also emphasizes its dedication to innovation and healthcare advancements.

Founded as Green Cross Corporation, GC Biopharma has a rich history spanning over 50 years, specializing in the development and manufacture of plasma derivatives and vaccines. Almost three years from now, the company made notable strides towards expanding its global footprint with the promising entry of Alyglo® (intravenous immunoglobulin G) into the U.S. market ongoing this year. In alignment with its vision for proactive healthcare evolution, GC Biopharma continuously seeks avenues for innovation, leveraging its core research and development capabilities in mRNA technology and lipid nanoparticles to cater to a spectrum of medical needs, particularly focusing on rare diseases and immunological conditions.

For further details and updates, please visit GC Biopharma's official website.

This announcement may contain forward-looking statements regarding GC Biopharma's operational performance. Such statements reflect current beliefs and expectations but are subject to various risks and uncertainties. GC Biopharma does not undertake any obligation to update such forward-looking statements unless mandated by law or stock exchange regulations.