GC Biopharma, a leading global biopharmaceutical company, announced the first shipment of BARYTHRAX inj., the world’s first recombinant anthrax vaccine. The product, jointly developed by the Korea Disease Control and Prevention Agency (KDCA) and GC Biopharma, was granted regulatory approval in April as Korea’s 39th locally developed new drug.
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The initial supply will be delivered to the KDCA for national stockpiling, supporting public health preparedness against biological threats, including potential bioterrorism.
BARYTHRAX inj. is the first anthrax vaccine globally to be developed using recombinant protein technology. Unlike conventional vaccines that use live attenuated or avirulent strain of Bacillus anthracis, BARYTHRAX inj. is based solely on the purified Protective Antigen (PA) protein, a principal component of the anthrax toxin.
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Clinical studies showed that BARYTHRAX inj. induces neutralizing antibodies that meet the predefined immunogenicity thresholds. This result supports its potential to effectively protect individuals in the event of anthrax exposure.
Furthermore, the safety assessment confirmed that the primary adverse events reported in the BARYTHRAX inj. group —such as injection-site pain, myalgia, and fatigue —were generally mild and temporary. No acute adverse reactions or deaths occurred, proving the vaccine’s strong safety profile.
Manufacturing is carried out at GC Biopharma’s advanced Hwasun facility in Korea, which can produce up to 10 million doses annually sufficient to immunize approximately 2.5 million people based on a four-dose regimen. The vaccine is also designed for rapid, scalable production in emergency scenarios.
“Delivering the world’s first recombinant anthrax vaccine marks a significant step forward in national biosecurity,” said Eun-Chul Huh, CEO of GC Biopharma. “We remain committed to supporting national biodefense and advancing vaccine security through innovation and strategic partnerships.”
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Source- PR Newswire
