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- A significant milestone towards entering the world's largest plasma product marketplace

YONGIN, SOUTH KOREA, GC Biopharma (006280.KS) today announced that the United States Food and Drug Administration (FDA) accepted 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 Biopharma's continuing efforts to help patients with immune disorder, said EC Huh, Ph. D., President of GC Biopharma. "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 Biopharma has been marketing Immune Globulin products in more than 30 countries in Asia, South America, and the Middle East.

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Biopharma in early 2018. Green Cross Corporation remains the company's legal name.

This press release may contain forward-looking statements that express GC Biopharma's and GC Biopharma USA, Inc.'s management's current beliefs and expectations. Such views do not represent any guarantee by either entity or its government of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma and GC Biopharma USA, Inc. undertake no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements they may make, except as required by law or stock exchange rule.