GCBiopharma will build production infrastructure to target the U.S. immunoglobulin market. The company will establish a dedicated production line for subcutaneous immunoglobulin (SCIG) at its Ochang plant in North Chungcheong and foster the next-generation plasma derivatives business as a future growth engine.
GC Biopharma said on the 16th that it signed a memorandum of understanding (MOU) with North Chungcheong Province and Cheongju for mid- to long-term investment in Cheongju. The company plans to invest a total of 530 billion won in the Ochang plant and other facilities from 2026 to 2033. The amount includes research and development (R&D) and the construction of production facilities, with 140 billion won to be invested in building SCIG production facilities.
That day, the company also said in a separate filing that it decided on a new facility investment of 140 billion won to build a new production line at the Ochang plant. The investment period runs from that day through the end of 2030.
Immunoglobulin is a high value-added plasma derivative used for primary immunodeficiency, autoimmune diseases, and neurological disorders, and global demand has been steadily increasing with aging populations and broader treatment indications.
This investment is notable not as a simple capacity expansion but as securing a production base to expand into the U.S. market.
The company recently announced its "The Fab Five" strategy, selecting five key pipelines with strong marketability and strategic importance, and among them positioned the 20% SCIG candidate "GC5136B" as its top-priority development asset.
Currently in the nonclinical stage, GC5136B aims to submit an investigational new drug (IND) application for a phase 3 clinical trial to the U.S. Food and Drug Administration (FDA) next year, based on an optimized manufacturing process. The company plans to build a dedicated production line in advance to quickly scale up production and supply after commercialization.
The reason GC Biopharma is focusing on SCIG is the strong growth potential of the U.S. market.
The U.S. immunoglobulin market is the world's largest at about $14.4 billion (about 20 trillion won) annually, and demand has recently been shifting from hospital-administered intravenous immunoglobulin (IVIG) to subcutaneous injection (SCIG) formulations that patients can self-administer at home. In particular, there are currently only three 20% high-concentration SCIG products sold in the United States, which the company believes leaves room for new entrants.
GC Biopharma set a mid- to long-term goal of securing a double-digit market share in the U.S. immunoglobulin market after GC5136B is commercialized. Its strategy is to improve profitability by boosting production efficiency and cost competitiveness through a proprietary manufacturing process.
At the end of 2023, the company won U.S. Food and Drug Administration (FDA) approval and entered the U.S. market with ALYGLO, a blood product for treating congenital immunodeficiency. Sales have been growing since its local launch in Jul. 2024. First-quarter sales this year were 34.9 billion won, about four times higher than the first quarter of last year (8.6 billion won).
Heo Eun-cheol, CEO of GC Biopharma, said, "This investment is an important decision to build on the success of our immunoglobulin product 'Alyglo' in the U.S. market," and added, "We will work closely with local governments to expand high value-added production infrastructure and continuously strengthen our competitiveness in plasma derivatives."
Meanwhile, GC Biopharma recently received an upfront payment of about 308.7 billion won after its affiliate Curevo was acquired by Eli Lilly and Company. The company plans to accelerate investment in the Ochang plant and the development of key pipelines with the cash it has secured.