The World's First "Recombinant Anthrax Vaccine": GC Biopharma applies for MFDS Approval

2023-11-06

疫苗临床2期上市批准临床结果

YONGIN, South Korea, Nov. 5, 2023 /PRNewswire/ -- GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of "GC1109", an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug Safety (MFDS).

'GC1109' contains protective antigen (PA) as its active pharmaceutical ingredients produced by recombinant DNA technology which delivers 2 types of proteins that comprise anthrax toxin, namely, lethal factor (LF) and edema factor (EF), into cells. If approved, "GC1109" will be the world's first recombinant anthrax vaccine.

Anthrax, caused by Bacillus anthracis, is a Class 1 infectious disease by the Infectious Disease Control and Prevention Act with a lethality rate of as high as 97% if one is not treated early. In order to prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been working on developing a recombinant vaccine for anthrax since 2002.

In the Phase II clinical trial, the vaccine's immunogenicity and safety has been demonstrated with healthy volunteers, where subjects who received intramuscular administration of GC1109 generated antibodies sufficient enough to neutralize anthrax toxins, while adverse drug reactions or solicited adverse events were similar to those of the placebo group.

Since it is unethical to expose human volunteers to lethal Bacillus anthracis, and field trials are not feasible due to a low incidence of anthrax, human clinical efficacy studies for an anthrax vaccine cannot be conducted. In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, animal efficacy data can be used to establish the vaccine's clinical benefit if evidence from the animal studies provide substantial grounds for the effectiveness of the product. In the animal efficacy study, GC1109 induced neutralizing antibody which remained at a high level even after 6 months following the 4th dose of the vaccine, with high survival rate against the bacillus anthracis spore challenge.

GC Biopharma stated, "We believe in the significance of our journey to localize the anthrax vaccine in terms of securing vaccine sovereignty, while promoting public health and national security. GC Biopharma will continue to lead the localization 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."

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century.

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

[email protected]

Yelin Jun

[email protected]

SOURCE GC Biopharma

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构