|Title||US FDA Accepts GC Pharma’s Biologics License Application for Immune Globulin 'GC5107'|
|Date of registration||2021-05-05|
A significant milestone towards entering the world's largest plasma product marketplace
YONGIN, SOUTH KOREA, 5 MAY 2021 - GC Pharma (006280.KS) today announced that the United States Food and Drug Administration (FDA) accepted the the company’s Biologics License Application (BLA) for 'GC5107 (Immune Globulin Intravenous (Human),10% Liquid)’ intended for the treatment of Primary Humoral Immunodeficiency (PI), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the application is in February 2022.
The application includes positive data from a Phase III study with PI (Primary Humoral Immunodeficiency) patients in North America. In the trials, all primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied.
"The acceptance of our application for GC5107 is yet another important milestone in GC Pharma’s continuing efforts to help patients with immune disorder, said EC Huh, Ph. D., President of GC Pharma. “If approved, our IGIV product will provide a meaningful therapeutic option for clinicians and their patients. We look forward to working with the FDA during the review of this application.”
GC Pharma has been marketing Immune Globulin products in more than 30 countries in Asia, South America, and Middle East.
About GC Pharma
GC Pharma (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 Pharma 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. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company's legal name.
This press release may contain forward-looking statements, which express the current beliefs and expectations of GC Pharma's management. Such statements do not represent any guarantee by GC Pharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Pharma 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.
|Number||Date of registration||Title||Attachment File||Number of clicks|
|211||2021-05-05||US FDA Accepts GC Pharma’s Biologics License Application for Immune Globulin 'GC5107'||667|
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|207||2021-02-26||GC Pharma Submits Biologics License Application to US FDA for Immune Globulin 'GC5107'||880|
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