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U.S. FDA Accepts Biologics License Application for GC Biopharma's GC5107B (Immune Globulin Intravenous (Human), 10% Liquid)

By PRNEWSWIRE

Published : July 31, 2023 - 15:10

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YONGIN, South Korea, July 31, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License Application (BLA) for its GC5107B (Immune Globulin Intravenous (Human) for patients with primary humoral immunodeficiency (PI).

The Prescription Drug User Fee Act (PDUFA) target action date is January 13, 2024. If approved, GC Biopharma would be able to provide more treatment options for patients with PI in the U.S.

GC Biopharma aims to enter the U.S. market in the second half of 2024 if GC5107B is approved by the FDA as anticipated.

While the U.S. immunoglobulin market size is estimated at about US$ 10.4 billion in 2022 (as per MRB[1] 2022), there have been sporadic shortages as there are only a small number of immunoglobulin manufacturers considering the need for a massive investment in facility and sophisticated production know-hows.

About GC5107B

GC5107B is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. The steps are "Fractionation I+III, solvent/detergent (S/D) treatment, and Nanofiltration."

About Primary Humoral Immunodeficiency

Primary humoral immunodeficiency disease comprises a large, heterogenous group of disorders resulting from inborn errors of immunity. Patients with PI are unable to mount an immune response to pathogens and can experience recurrent bacterial, viral, fungal, and protozoal infections as a result. Global estimates project that up to 6 million people may be living with PI, but only 650,000 people worldwide have been diagnosed[2],[3],[4].

About GC Biopharma

GC Biopharma (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 Biopharma 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.

This press release may contain forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma 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.

[1] MRB (Marketing Research Bureau): The Plasma Proteins Market In the United States 2022

[2] Rezaei N et al. Introduction on Primary Immunodeficiency Diseases. In: Rezaei N, Aghamohammadi A, and Notarangelo LJ (Eds.), Primary Immunodeficiency Diseases 2017:1-81.

GC Biopharma Contacts (Media)

Sohee Kim
shkim20@gccorp.com

Yelin Jun
yelin@gccorp.com