GC Biopharma, in partnership with Korea Disease Control and Prevention Agency (KDCA), has gained regulatory approval from Korea's Ministry of Food and Drug Safety (MFDS) for BARYTHRAX—world's first recombinant protein anthrax vaccine. This is Korea's 39th new drug and a milestone in biodefense readiness.

Key Highlights

Approval Received from Korean Regulatory Authority

• BARYTHRAX was approved on April 8, 2025, after it was applied for on October 31, 2023.

• The vaccine is produced collaboratively by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA).

Anthrax Breakthrough Prevention

• Anthrax, which is caused by Bacillus anthracis, is a class-1 infectious disease and a bioterror threat with a 97% death rate if left untreated.

• BARYTHRAX employs genetically modified protective antigen proteins to stimulate an immune response and counteract anthrax toxins.

Safer Replacement for Conventional Vaccines

• BARYTHRAX avoids the use of live or attenuated bacteria, unlike traditional anthrax vaccines, removing residual toxin risk.

• It also solves the issue of diminishing immunogenicity in recombinant vaccines through stability over time.

Success in Clinical and Animal Trials

• Phase II clinical trials revealed robust antibody response in healthy adults with no serious side effects.

• Animal trials under Korea's "Animal Rule" validated long-term antibody persistence and excellent survival rates after infection challenge.

Importance to National Security and Public Health

• The approval places GC Biopharma in a position to provide Korea's anthrax vaccine stockpile for emergency readiness.

• The vaccine complements GC Biopharma's diversified portfolio, including blood products and other essential vaccines.

Statements from Officials or Leaders
Eun-chul Huh, GC Biopharma President and CEO, said:
This milestone reaffirms our dedication to local production of essential medicines for public health and national security. GC Biopharma will continue to take the lead in securing stable supplies of key medical products, as we have with other vaccines and blood products since the company's inception."

With this achievement, GC Biopharma solidifies its leadership in vaccine technology and biosecurity. For healthcare distributors and pharmacists, BARYTHRAX is a pivotal leap forward in emergency medicine supply chains, especially for institutions handling national health emergencies and biohazard risks.