South Korean biopharmaceutical company GC Biopharma announced on Wednesday that it has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA).
With this approval, BARTHYRAX has become Korea's 39th novel drug.
Anthrax, caused by Bacillus anthracis, is class-1 infectious disease capable of surviving extreme conditions and spreading easily through airborne transmission. If untreated, its fatality rate can reach up to 97%, making it a significant threat as a potential biological weapon.
GC Biopharma says that BARYTHRAX utilises protective antigen (PA) proteins produced through genetic recombination techniques. In anthrax infections, PA acts as a gateway for 2 Bacillus anthracis toxins, lethal factor (LF) and edema factor (EF), to enter host cells. By utilising PA proteins, the vaccination can train and stimulate an immune response to neutralise anthrax. It also improves vaccine stability by overcoming a key limitation of recombinant protein vaccines, a reduction in immunogenicity within the shelf life.
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GC Biopharma's BARYTHRAX receives Korean regulatory approval