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..

GC Biopharma（006280.KS），一家全球领先的生物制药公司，今天宣布了世界上首个重组炭疽疫苗BARYTHRAX inj.的首次发货。该产品由韩国疾病控制与预防中心（KDCA）和GC Biopharma共同开发，于今年四月获得监管批准，成为韩国第39种本土研发的新药。

The initial supply will be delivered to the KDCA for national stockpiling, supporting public health preparedness against biological threats, including potential bioterrorism.

初始供应将交付给韩国疾病控制与预防中心（KDCA），用于国家战略储备，以支持针对包括潜在生物恐怖主义在内的生物威胁的公共卫生防范工作。

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..

BARYTHRAX注射剂是全球首个采用重组蛋白技术开发的炭疽疫苗。与使用减毒或无毒炭疽芽孢杆菌株的传统疫苗不同，BARYTHRAX注射剂仅基于纯化的保护性抗原（PA）蛋白，这是炭疽毒素的主要成分。

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.

临床研究表明，BARYTHRAX注射剂能够诱导达到预定义免疫原性阈值的中和抗体。这一结果支持了它在炭疽暴露情况下有效保护个体的潜力。

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.

此外，安全性评估确认，BARYTHRAX注射组报告的主要不良事件（如注射部位疼痛、肌肉痛和疲劳）通常为轻度且短暂。未发生急性不良反应或死亡事件，证明了该疫苗良好的安全性。

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..

制造是在韩国GC Biopharma先进的和顺工厂进行的，该工厂每年可生产多达1000万剂疫苗，按照四剂方案足以免疫大约250万人。该疫苗还设计用于在紧急情况下快速、可扩展的生产。

'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.'

“交付世界上首个重组炭疽疫苗标志着国家生物安全向前迈出了重要一步，”GC Biopharma首席执行官Eun-Chul Huh表示。“我们仍然致力于通过创新和战略合作伙伴关系来支持国家生物防御并提升疫苗安全性。”

About GC Biopharma

关于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.

GC Biopharma（前身为Green Cross Corporation）是一家总部位于韩国龙仁的生物制药公司。该公司在血浆衍生物和疫苗的开发与生产方面拥有超过半个世纪的经验，并通过2024年成功进入美国市场的Alyglo®（静脉注射免疫球蛋白G）扩展其全球影响力。

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).

为了满足未来医疗保健需求的使命，GC Biopharma继续通过其在蛋白质、mRNA和脂质纳米颗粒（LNP）药物递送平台工程方面的核心研发能力推动创新，开发罕见病以及免疫学与炎症（I&I）领域的治疗药物。

To learn more about the company, visit https://www.gcbiopharma.com/eng/.

要了解更多关于该公司的信息，请访问 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.

本新闻稿中的前瞻性声明可能包含生物制药内容，表达GC Biopharma管理层当前的信念和期望。此类声明不代表GC Biopharma或其管理层对未来的业绩做出任何保证，并且涉及已知和未知的风险、不确定性及其他因素。

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 不承担更新或修改本新闻稿中包含的任何前瞻性声明或其可能作出的任何其他前瞻性声明的义务，除非法律或证券交易所规则要求。

GC Biopharma Contacts (Media)

GC生物制药联系人（媒体）

Sohee Kim

金素熙

shkim20@gccorp.com

shkim20@gccorp.com

Yelin Jun

岳麟俊

yelin@gccorp.com

叶林@gccorp.com

Yoonjae Na

罗允载

yjy6520@gccorp.com

yjy6520@gccorp.com

Source: prnewswire.com

来源：prnewswire.com