GC Biopharma’s hematologic treatment is entering the United States, the world’s largest market, for the first time as a Korean product.

GC Biopharma said Monday that the company received marketing approval for its intravenous immunodeficiency treatment, Alyglo, from the U.S. Food and Drug Administration last Friday (local time).

The company plans to launch Alyglo in the second half of next year through its U.S. subsidiary, GC Biopharma USA. Alyglo is a 10 percent immunoglobulin for intravenous administration to treat primary humoral immunodeficiency, also known as congenital immunodeficiency.

GC Biopharma said it completed a phase 3 clinical trial in 2020 in North America in patients with primary immunodeficiency, meeting efficacy and safety standards.

In 2021, GC Pharma submitted a Biologics License Application (BLA) for Alyglo to the FDA in 2021 but received a delayed approval decision in February last year because the FDA could not conduct an on-site inspection of the company’s blood product manufacturing facility in Ochang, North Chungcheong Province within the targeted timeframe due to Covid-19.

This past April, GC Biopharma received an FDA on-site inspection of its facility and resubmitted the BLA in July in consultation with the FDA. The FDA approval came about a month before the deadline of Jan. 13 next year under the Prescription Drug User Fee Act (PDUFA.

GC Biopharma’s attempt to enter the U.S. blood products market goes back further. In 2015, the company applied to the FDA for marketing authorization for a 5 percent immunoglobulin formulation but was advised to supplement data on its manufacturing process in 2016 and 2017.

GC Biopharma said this is the first time a Korean blood product has successfully entered the U.S. market, adding that blood products, which require large-scale capital investment and sophisticated production experience, are now in short supply due to the limited number of producers worldwide.

The U.S. immunoglobulin market is valued at about $10.4 billion, and the demand for the product continues to grow due to the increasing prevalence of autoimmune diseases amid population aging.

"We are pleased to provide safe and effective treatment options for immunodeficiency patients in the U.S. with this approval," GC Biopharma CEO Huh Eun-chul said. "As we have dedicated ourselves to serving patients with rare diseases in every country, we are committed to expanding our reach globally to create a better care experience for patients and healthcare professionals."