- First anthrax vaccine developed using recombinant DNA technology
- Annual production capacity of up to 10 million doses at GC Biopharma's facility
YONGIN, South Korea, Dec. 8, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, today 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.
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.
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."
About GC Biopharma
GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo® (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/
This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.
GC Biopharma Contacts (Media)
Sohee Kim
shkim20@gccorp.com
Yelin Jun
yelin@gccorp.com
Yoonjae Na
yjy6520@gccorp.com
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SOURCE GC Biopharma
