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– A significant milestone on a historic entry into the world’s largest plasma product marketplace

YONGIN, SOUTH KOREA - August 1, 2023 -- GC Biopharma Inc., a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, announced that the US 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 17 years and older with primary humoral immunodeficiency (PI). The Prescription Drug User Fee Act (PDUFA) goal date for a decision on the resubmission is January 13, 2024. If approved, GC Biopharma could provide more treatment options for patients with PI in the US. GC Biopharma aims to enter the US market in the second half of 2024 if GC5107B is approved by the FDA as anticipated. The US immunoglobulin market is estimated at US $10.4 billion in 2022 (as per MRB^[1] 2022); GC Biopharma looks forward to working closely with the FDA during its review.

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, heterogeneous group of disorders resulting from inborn errors of immunity. Patients with PI cannot mount an immune response to pathogens and can experience recurrent bacterial, viral, fungal, and protozoal infections. 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]

^[1] MRB (Marketing Research Bureau): The Plasma Proteins Market In the United States 2022
^[2] Rezaei N et al. Introduction to Primary Immunodeficiency Diseases. In: Rezaei N, Aghamohammadi A, and Notarangelo LJ (Eds.), Primary Immunodeficiency Diseases 2017:1-81.
^[3] Parvaneh L. et al. Eur Ann Allergy Clin Immunol 2019; 51(1):32-37.
^[4] Lindegren M.L. et al. MMWR Recomm Rep 2004; 53:1-2

About GC Biopharma

GC Biopharma (formerly 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 global plasma protein and vaccine product manufacturers and has been dedicated to quality healthcare solutions for over half a century.

This press release may contain forward-looking statements expressing 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.