Innovative: GC Biopharma Seeks MFDS Approval
GC Biopharma, in collaboration with the Korea Disease
Control and Prevention Agency (KDCA), has submitted "GC1109" for
marketing approval to the Korean Ministry of Food and Drug Safety (MFDS). This
anthrax vaccine is the world's first of its kind, developed using recombinant
DNA technology, with protective antigen (PA) as its primary ingredient,
targeting the lethal and edema factors of anthrax toxins.
The Phase II clinical trial demonstrated the vaccine's
safety and effectiveness in generating neutralizing antibodies against anthrax
toxins in healthy volunteers. Due to ethical constraints, human efficacy
studies are not feasible. Therefore, GC Biopharma utilized animal efficacy data
under the "Animal Rule" to support the vaccine's effectiveness, where
GC1109 induced high levels of neutralizing antibodies, providing substantial
evidence for its clinical benefit.
GC Biopharma's commitment to localizing the anthrax vaccine
for public health and national security is significant, emphasizing their
dedication to medical sovereignty and supply stability. As a leading
biopharmaceutical company, GC Biopharma has a longstanding commitment to
delivering life-saving therapeutics and vaccines, contributing to quality
healthcare solutions globally.
This announcement, though forward-looking, is subject to
risks and uncertainties. GC Biopharma undertakes no obligation to update or
revise any statements in this release, maintaining compliance with regulatory
requirements.
More Information : https://www.techdogs.com/tech-news/pr-newswire/the-worlds-first-recombinant-anthrax-vaccine-gc-biopharma-applies-for-mfds-approval
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