123ArticleOnline Logo
Welcome to 123ArticleOnline.com!
ALL >> General >> View Article

Innovative: Gc Biopharma Seeks Mfds Approval

Profile Picture
By Author: Ben Gross
Total Articles: 256
Comment this article
Facebook ShareTwitter ShareGoogle+ ShareTwitter Share

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

Total Views: 50Word Count: 200See All articles From Author

Add Comment

General Articles

1. Finding The Perfect Ink: A Guide To Locating The Best Tattoo Artist In Chandigarh
Author: Welcome to Tricity Insight,

2. Showcasing Your Treasures: The Art Of Wall Display Cabinets And Floating Shelves
Author: adlercon way

3. The Best Upcoming Phones In 2024 In (january)
Author: upcoming smartphones

4. Swipestore
Author: swipestore

5. Shekaryogpeeth: A Beacon Of Wellness Founded By Shekhar Rathore
Author: shekhar rathore

6. Best Upvc Windows Manufacturers In Mangalore
Author: upvscservice

7. Während Ihrer Hochzeitsplanung Wird Es Viel Stress Geben
Author: Brautkleider

8. The Rise Of Online Vet Consultations By Snouters In Delhi
Author: Kajal Snouters

9. The Essential Role Of Pizza Boxes In The Modern Food Industry
Author: Vicki Ward

10. Traditional Meters Vs. Smart Meters: Understanding The Differences And Benefits
Author: polaris

11. Fiber Laser Cutting: Unveiling The Cutting-edge 2g Axis Acceleration
Author: Cameron

12. Porcelain Pool Coping
Author: Serapool

13. The Perfect Bathroom Accessories Guide For 2024
Author: Johnson Bathrooms

14. Bouncebit Raises $6m In Seed Funding Round To Build Bitcoin Restaking Infrastructure
Author: James Colin

15. Smart Comms: Leader In 2024 Spark Matrix™
Author: Ben Gross

Login To Account
Login Email:
Password:
Forgot Password?
New User?
Sign Up Newsletter
Email Address: