GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California

GC Biopharma, a South Korean pharmaceutical company, announced that its U.S. subsidiary, ABO Holdings, has received FDA approval for its plasma collection center located in Calexico, California.

Following the successful U.S. launch of ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, GC Biopharma acquired ABO Holdings in January to support the product’s expected mid-to long-term revenue growth.

With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey. The company plans to ramp up donor recruitment efforts in the second quarter, setting the stage for substantial business growth in the second half of the year.

Additionally, ABO Holdings is on track to complete construction of two new plasma centers in Texas and aims to obtain FDA approval for both facilities by 2027. GC Biopharma anticipates gradual growth in its source plasma business starting in the latter half of this year.

“With all six FDA-approved plasma centers now operational, the company is well-positioned to achieve sustainable revenue growth for Alyglo,” said Eun-chul Huh, President and CEO of GC Biopharma. “This milestone represents a significant contribution to our overall business profitability.”