GC Biopharma announced  that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA).

With the approval by MFDS, BARYTHRAX has become Korea's 39^th novel drug. Following the application on 31 Oct. 2023, GC Biopharma and KDCA successfully received the product approval from MFDS on 8th this month.

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.

BARYTHRAX utilizes 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 utilizing PA proteins, the vaccination can train and stimulate an immune response to neutralize anthrax.

Traditional vaccines are made by attenuating Bacillus anthracis or culturing non-pathogenic Bacillus anthracis, which may contain residual toxin components. BARYTHRAX, being the world's first recombinant protein anthrax vaccine, removed this risk and improved vaccine safety. 

BARYTHRAX has also improved vaccine stability by overcoming a key limitation of recombinant protein vaccines, which is "the reduction in immunogenicity within the shelf life". In the Phase II clinical trial, healthy adult subjects, who received the vaccination generated sufficient antibodies to neutralize anthrax toxins, while reporting no acute or severe adverse events.

Bacillus anthracis is highly lethal, making it unethical to carry out phase 3 human clinical trials. In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis of Korea, animal trials can be conducted as a substitute for phase 3 clinical studies. In the animal efficacy study, the vaccinated subjects maintained high levels of neutralizing antibodies even after 6 months following the 4^th dose of the vaccine, with a high survival rate against the Bacillus anthracis spore challenge.

The MFDS's approval, supported by GC Biopharma's production capacity, will pave the way for the company to supply Korea's essential anthrax vaccine reserve.

Eun-chul Huh, President and CEO of GC Biopharma, said, "This achievement underscores our commitment to localizing critical medicines for public health and national security. GC Biopharma will continue leading efforts to ensure stable supplies of essential medical products, as we have been doing with other vaccines and blood products since our founding."