#South Korea #GC Biopharma #Yongin #Anthrax Vaccine #BARYTHRAX inj.

GC Biopharma's Milestone in Vaccine Development

GC Biopharma, a prominent biopharmaceutical firm based in South Korea, recently made headlines with the shipment of the first doses of BARYTHRAX inj., recognized as the world's inaugural recombinant anthrax vaccine. This landmark achievement underscores the company's commitment to advancing public health initiatives and improving global health security against potential biological threats.

A Revolutionary Approach to Vaccination

BARYTHRAX inj. has been meticulously developed through cutting-edge recombinant DNA technology. This innovative approach sets it apart from traditional anthrax vaccines, which typically utilize a live attenuated or non-virulent strain of the Bacillus anthracis bacterium. Instead, BARYTHRAX inj. employs a purified version of the Protective Antigen (PA) protein, a key component found in anthrax toxins, promising a safer and more efficient immunization method.

Following its regulatory approval in April 2025 by the Korean authorities as the 39th domestically produced new drug, the initial comestible goods will be directed to the Korea Disease Control and Prevention Agency (KDCA). This strategic move aims to strengthen national stockpiling efforts, thereby enhancing public health readiness against various biological threats, including the potential for bioterrorism.

Clinical Trials Showcase Promising Results

Clinical evaluations have demonstrated that BARYTHRAX inj. generates neutralizing antibodies, successfully meeting pre-established immunogenicity benchmarks. These results indicate a promising protective efficacy for individuals who might be exposed to anthrax pathogens. The safety profile, critically evaluated during the trials, revealed that reported side effects such as injection site pain, muscle soreness, and overall fatigue were generally mild and transient. Remarkably, no severe adverse reactions or fatalities were documented during the studies, highlighting the vaccine's robust safety characteristics.

Manufacturing Capabilities and Future Outlook

Manufacturing for BARYTHRAX inj. occurs in GC Biopharma's state-of-the-art Hwasun facility, designed to produce up to 10 million doses annually. This production capacity is sufficient to immunize approximately 2.5 million individuals, assuming a four-dose regimen per person. The facility is also prepared for rapid scaling, ensuring swift vaccine availability in emergencies.

Eun-Chul Huh, CEO of GC Biopharma, emphasized the significance of delivering this revolutionary vaccine: “Bringing the world’s first recombinant anthrax vaccine to market represents a major advancement in our national biosecurity. Our commitment to bolstering national biodefense and vaccine security through ongoing innovation and strategic alliances remains steadfast.”

About GC Biopharma

Formerly known as Green Cross Corporation, GC Biopharma has over 50 years of experience in developing and manufacturing plasma derivatives and vaccines. The company is continuously expanding its global footprint, including a successful entry into the US market with the Alyglo® (intravenous immunoglobulin G) vaccine in 2024. The company aims to meet future healthcare demands through innovation, leveraging its expertise in protein engineering, mRNA technologies, and lipid nanoparticle drug delivery systems to create therapeutics focused on rare diseases and immunological concerns.

For more details about GC Biopharma and its offerings, visit their official website at GC Biopharma.