GC Biopharma announced on the 1st that it had applied for product approval for the anthrax vaccine 'GC1109' jointly developed with the Korea Disease Control and Prevention Agency (KCDC) to the Ministry of Food and Drug Safety (KFDA).
GC1109 is a vaccine made using genetic recombination technology to produce a protective antigen (PA) protein that delivers two types of toxins, including LF (lethal factor) and EF (Edema factor), into cells. If the government approves, it will become the world's first recombinant protein anthrax vaccine.
Anthrax, caused by anthrax, is a class 1 statutory infectious disease with a fatality rate of 97% if not treated early. GC Green Cross has been providing anthrax vaccine through a research service project of the Korea Disease Control and Prevention Agency since 2002 to prepare for national crises such as bioterrorism. was developing
As a result of the last phase 2 of the clinical trial targeting healthy adults, it was confirmed that the anthrax vaccine group produced sufficient antibodies capable of neutralizing anthrax toxin, and the rates of adverse drug reactions and predicted adverse events tended to be similar between the two groups. The immunogenicity and safety of the vaccine have been confirmed.
Heo Eun-Cheol, CEO of GC Biopharma, said, "I think the challenge of localizing the anthrax vaccine is significant in securing vaccine sovereignty and promoting national public health security." He added, "We have taken the lead in localizing essential medicines such as vaccines and blood products and will continue to maintain a stable supply of basic medicines and contribute to supply."
The link to the Korean version of this article is below.
▷GC Biopharma, 세계 최초 ‘재조합 단백질 탄저백신’ 품목허가 신청
By_BK Min, KDFN kdf@kdfnews.com
