GCBiopharma will expand its push into the U.S. market with the blood product Alglio. GC Biopharma said it expects Alglio to post $150 million (221.3 billion won) in U.S. sales this year. The goal is to reach $300 million (442.6 billion won) in sales in 2028.
Alglio is a blood product administered to patients with immunodeficiency. Blood products are medicines made by separating various components in blood. Alglio received marketing approval from the U.S. Food and Drug Administration (FDA) at the end of 2023 and was launched.
Alglio is currently administered by intravenous injection. The company plans to develop it as a subcutaneous injection. Subcutaneous injections are convenient because patients can self-administer without going to the hospital. The goal is to enter U.S. clinical trials in 2027.
GC Biopharma also plans to secure growth engines for the next 10 years with treatments for rare diseases and next-generation vaccines. GC Biopharma is jointly developing a Fabry disease treatment with Hanmi Pharmaceutical. Fabry disease is a condition in which an enzyme abnormality in the cellular organelle lysosome causes excessive accumulation of glycolipids, leading to death. Phase 1 and 2 clinical trials are underway in the United States, Korea, and Argentina. Hunterase, a treatment for Hunter syndrome, is also a key product. Hunter syndrome is a rare disease characterized by skeletal abnormalities such as a protruding forehead and cognitive decline, leading to death before age 30.
In its vaccine business, it has produced a cumulative 400 million doses of flu vaccine. Recently, it moved to secure a next-generation vaccine platform that can respond quickly to infectious disease outbreaks. As part of a project supported by the Korea Disease Control and Prevention Agency, it is developing a COVID-19 vaccine based on an mRNA-LNP platform. Once developed, an mRNA Vaccine can be quickly adapted to produce various vaccines by swapping in the viral genetic information.
GC Biopharma is jointly developing an in vivo CAR-T cell therapy with AbClon. Because a single injection can alter immune cells in the patient's body and treat cancer, it is called the "dream anticancer drug." The two companies are identifying new drug candidates targeting blood cancers and conducting preclinical and clinical studies.
GC Biopharma plans to build an integrated healthcare ecosystem spanning diagnosis, prevention, treatment, and management with affiliates such as GC Cell, GC Genome, and GC Care. A GC Biopharma official said, "Based on our existing strengths in blood products and vaccines, we will leap forward as a global healthcare corporations by 2030."