GC Wellbeing

YONGIN, SOUTH KOREA, 31 July 2023 – 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[i] 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[ii],[iii],[iv].

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

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

[iii] Parvaneh L. et al. Eur Ann Allergy Clin Immunol 2019; 51(1):32-37.

[iv] Lindegren M.L. et al. MMWR Recomm Rep 2004; 53:1-2