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GC Biopharma headquarters. / GC Biopharma

GC Biopharma has received approval to begin a phase 2 clinical trial of its independently developed COVID-19 messenger RNA (mRNA) vaccine candidate, marking a major step toward domestic production.

The company said on Sept. 11 that the Ministry of Food and Drug Safety approved the investigational new drug application for a domestic phase 2 trial of its COVID-19 mRNA vaccine candidate, GC4006A.

The phase 2 trial will enroll healthy adults and elderly participants aged 19 to 85 and directly compare GC4006A with an active control to assess the optimal clinical dose and immunogenicity of the candidate.

GC Biopharma plans to begin dosing the first patient within this year and move ahead with the phase 2 trial in earnest, with the goal of submitting an IND for a phase 3 trial in 2027.

GC Biopharma is the only South Korean company currently carrying out a government-backed project aimed at achieving domestic self-sufficiency in mRNA vaccines by 2028 without delays.

Building on technologies accumulated since 2019, the company has internalized the entire mRNA drug production process, from cell line development and mRNA synthesis to lipid nanoparticle (LNP) formulation, finished-product manufacturing and precision quality analysis.

Based on its proprietary mRNA-LNP platform to be validated through the trial, GC Biopharma plans to expand its pipeline beyond commercialization of a COVID-19 vaccine into areas including next-generation cancer immunotherapies and treatments for rare genetic diseases.

According to global market research firms, the worldwide market for mRNA vaccines and therapeutics is projected to grow to about $31.3 billion, or roughly 42 trillion won, by 2030.

“The phase 2 IND approval is an important milestone in firmly validating our mRNA-LNP platform through clinical trials and securing domestic vaccine sovereignty,” said Lee Jae-woo, head of development at GC Biopharma. “We are considering expanding the pipeline into a variety of disease areas in addition to achieving vaccine self-sufficiency.”

                                                                                                       Moon Jeong-woo