GC Biopharma, a South Korean pharmaceutical company, announced that the FDA has approved its plasma collection center in Calexico, California, operated by its U.S. subsidiary ABO Holdings. This approval marks a significant milestone in the company's U.S. expansion strategy following the successful launch of ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid in the American market.
The Calexico facility is the final of six plasma collection centers to receive FDA approval, with the others located across California, Utah, and New Jersey. This regulatory clearance enables GC Biopharma to strengthen its plasma supply chain for immunoglobulin production, a critical component for treating various immune disorders.
"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."
Strategic Acquisition and Expansion Plans
GC Biopharma acquired ABO Holdings in January 2025 specifically to support the mid-to-long-term growth of ALYGLO, which entered the U.S. market in 2024. The acquisition aligns with the company's vertical integration strategy, ensuring reliable access to source plasma—a critical raw material for immunoglobulin products.
The company plans to intensify donor recruitment efforts in the second quarter of 2025, preparing for substantial business growth in the latter half of the year. This timing is strategic, as plasma collection typically requires several months of processing before it can be utilized in manufacturing.
Beyond the six operational centers, ABO Holdings is constructing two additional plasma collection facilities in Texas, with FDA approval targeted by 2027. This expansion will further enhance GC Biopharma's plasma collection capacity and geographic diversification across the United States.
Plasma Products Market Context
The approval comes at a time when the global immunoglobulin market continues to experience high demand. Intravenous immunoglobulin (IVIG) products like ALYGLO are essential therapies for patients with primary immunodeficiency disorders, certain autoimmune conditions, and other immune-mediated diseases.
The U.S. represents the largest market for plasma-derived products globally, with consistent supply challenges that have been exacerbated by collection disruptions in recent years. By establishing its own collection network, GC Biopharma aims to mitigate supply risks while controlling a larger portion of its value chain.
Company Background and Capabilities
GC Biopharma, formerly known as Green Cross Corporation, brings over 50 years of experience in plasma derivatives and vaccines to its U.S. operations. The company has established itself as a significant player in the biopharmaceutical industry, particularly in plasma-derived products.
Beyond immunoglobulins, GC Biopharma is leveraging its R&D capabilities in protein engineering, mRNA technology, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for rare diseases and immunology/inflammation conditions.
The company's strategic focus on plasma collection reflects the critical importance of securing raw materials in the competitive immunoglobulin market, where reliable plasma supply directly impacts production capacity and market position.
Market Implications
For patients dependent on immunoglobulin therapies, the expansion of collection facilities potentially contributes to a more stable supply chain. Healthcare providers may benefit from increased competition in the IVIG market, which has historically experienced periodic shortages.
As GC Biopharma continues to establish its presence in the U.S. market, the company's vertical integration approach—controlling both collection and manufacturing—positions it to compete more effectively with established players in the plasma derivatives sector.
The company expects to see gradual growth in its source plasma business beginning in the second half of 2025, with the full impact of the expanded collection network likely to materialize in subsequent years as the Texas facilities come online and all centers reach optimal collection volumes.
