South Korean biopharmaceutical company GC Biopharma (KRX: 006280) announced on Wednesday that its US subsidiary, ABO Holdings, has received US Food and Drug Administration (FDA) approval for its plasma collection centre in Calexico, California.
The approval follows GC Biopharma's recent acquisition of ABO Holdings in January 2025, a strategic move aimed at supporting the long-term revenue potential of ALYGLO, its immune globulin intravenous product, which was recently launched in the US market.
With this authorisation, ABO Holdings now operates six plasma collection centres across California, Utah, and New Jersey. The company plans to intensify donor recruitment efforts in the second quarter to support expanded operations.
ABO Holdings is also constructing two additional plasma centres in Texas, with FDA approval targeted by 2027.
GC Biopharma anticipates that its source plasma business will enter into a phase of gradual growth in the latter half of 2025.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA