Innovative: Gc Biopharma Seeks Mfds Approval

By Author: Ben Gross
Total Articles: 433
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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