[Asia Economy Reporter Seo So-jeong] GC Green Cross is entering the U.S. market with its flagship blood products.
GC Green Cross (CEO Heo Eun-cheol) announced on the 26th that it has submitted a Biologics License Application (BLA) for its immunoglobulin product ‘GC5107’ to the U.S. Food and Drug Administration (FDA). This is the first time a domestic blood product is approaching global commercialization.
GC Green Cross completed the Phase 3 clinical trial of GC5107 in North America last year. In the clinical trial targeting patients with primary immunodeficiency, the efficacy and safety evaluation variables met the FDA guidelines.
In terms of efficacy, after administering GC5107 and measuring the frequency of acute and severe bacterial infections over 12 months, the result was 0.02, which is lower than the FDA standard of 1. The company explained that the safety evaluation also met all criteria, with no drug-related deaths or serious adverse reactions observed.
The U.S. immunoglobulin market is approximately $8.1 billion in size, and demand for immunoglobulin is continuously increasing due to the recent rise in autoimmune diseases.
Heo Eun-cheol, CEO of GC Green Cross, said, “This BLA submission represents a major leap toward the goal of entering the U.S. market with our domestic biopharmaceutical business,” adding, “Based on a product already recognized in the global market, we plan to provide meaningful treatment options to medical professionals and patients in the U.S.”
Meanwhile, the FDA approval process for biopharmaceutical products generally involves a 60-day preliminary review to determine whether the submitted data is acceptable, followed by a final approval decision within approximately 10 months.
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