GC Biopharma has received the green light to start Phase 2 clinical trials for its own mRNA COVID-19 vaccine. This is a key step in South Korea’s plan to make its own vaccines by 2028. GC Biopharma is not stopping at one vaccine. The company is building its own mRNA platform to develop new treatments for infectious diseases and cancer.
GC Biopharma's Phase 1 clinical trial for its mRNA COVID-19 vaccine candidate involved adults aged 19–64 and confirmed safety and tolerability over a one-month period.
GC Biopharma says its AI-optimized mRNA structures have raised efficacy by more than 50% compared to global standards. Its LNP delivery system, developed and patented in-house, is built to target organs like the spleen, liver, and lungs. The company is already using this platform for technology exports and contract development and manufacturing (CDMO) deals. More than 10 biotech partners are now testing its platform.
The South Korean government’s pandemic preparedness mRNA vaccine development support project is coordinated by the Korea Disease Control and Prevention Agency (KDCA), National Institute of Health, and Korea Health Industry Development Institute, with the national target of achieving mRNA vaccine self-sufficiency by 2028.
A JoongAng Ilbo industry report says GC Biopharma is the only local company running the government’s mRNA vaccine independence program. This means the country is relying on one private developer for this key goal. The Phase 2 trial, approved by the MFDS, will include adults aged 19–85. It will compare GC Biopharma’s vaccine to an approved shot to find the best dose and measure immune response.
GC Biopharma is also looking beyond infectious diseases. The company is working with AbClon to develop an ‘in vivo CAR-T’ therapy. This next-generation cancer treatment could avoid the high costs and logistics of traditional CAR-T. Instead of taking immune cells out of the body and engineering them, this method aims to create CAR-T cells inside the body with a single shot. If it works, it could make cell therapy cheaper and easier to access.
Jung Jae-wook, head of R&D at GC Biopharma, said, “Through the development of the mCOVID vaccine, we will demonstrate that GC Biopharma’s proprietary mRNA platform and full-cycle production infrastructure are functioning properly,” and stressed the company’s plan to deliver both vaccine self-sufficiency and global innovation.
Several Korean outlets, including HuffPost Korea, report that GC Biopharma plans to file for Phase 3 trials in 2027 and seek product approval in 2028. This matches the government’s timeline for domestic mRNA vaccine self-sufficiency. The Phase 2 trial is set to start dosing patients this year, after Phase 1 confirmed safety and tolerability.
GC Biopharma’s approach is a direct answer to the global boom in mRNA drugs. The market is expected to grow from 15 trillion to 42 trillion Korean won by 2030. By investing in AI design, its own delivery tech, and full vertical integration, GC Biopharma wants to be a serious player in the next wave of biopharma manufacturing. If the company meets its targets, South Korea could soon have real vaccine independence and a homegrown platform for advanced therapies.
