GC Biopharma has sought marketing approval from the Korean Ministry of Food and Drug Safety (MFDS) for anthrax vaccine GC1109.
The company co-developed the vaccine along with the Korea Disease Control and Prevention Agency.
GC1109 has a protective antigen as its active pharmaceutical ingredient, created using recombinant DNA technology. This approach involves two types of proteins, comprising anthrax toxin, lethal factor and oedema factor.
On obtaining approval, GC1109 will become the first recombinant anthrax vaccine globally.
A Phase II clinical trial analysed the safety and immunogenicity of the intramuscular dose of GC1109 in healthy subjects.
Findings showed that the vaccine-induced antibodies neutralise anthrax toxins.
Vaccine-associated adverse drug reactions or solicited adverse events were in line with those observed in the placebo arm.
GC Biopharma stated: “We believe in the significance of our journey to localise the anthrax vaccine in terms of securing vaccine sovereignty while promoting public health and national security.
“GC Biopharma will continue to lead the localisation of critical medicines and contribute to the stable supply of basic medical supplies as it has been doing for other vaccines and blood products since the foundation of the company.”
Classified as a Class 1 infectious disease under the Infectious Disease Control and Prevention Act, anthrax is caused by Bacillus anthracis.
GC Biopharma and KDCA have been collaborating since 2002 to develop a recombinant anthrax vaccine.
