GC Biopharma Launches ALYGLO™ 10% Liquid for Primary Humoral Immunodeficiency in US

TEANECK, N.J., Sept. 9, 2024 — GC Biopharma USA, Inc. has launched its immunoglobulin (IG) product ALYGLO, a 10% intravenous immunoglobulin therapy, for adults aged 17 and older suffering from primary humoral immunodeficiency (PI). PI is a rare, chronic disorder characterized by an impaired ability to produce antibodies, compromising the immune system's effectiveness in combating infections.

ALYGLO, an immune globulin intravenous solution, has successfully met the safety and efficacy criteria outlined by the FDA during Phase 3 clinical trials. The product's manufacturing process employs Cation Exchange Chromatography (CEX) to remove coagulation factor XIa (FXIa) to undetectable levels, potentially enhancing patient safety. The FDA approved ALYGLO on December 15, 2023.

Dr. Eun Chul Huh, President, and CEO of GC Biopharma, described the U.S. launch of ALYGLO as a significant milestone for both the company and patients with primary immunodeficiency disease. He emphasized that the launch aligns with GC Biopharma's mission to improve the health and quality of life for individuals suffering from rare and chronic diseases worldwide. He also noted that the company's investment in the U.S. market demonstrates its commitment to research and development and to introducing future products that will benefit patients and healthcare professionals.

ALYGLO is available via a limited distribution network of top national Specialty Pharmacy providers, ensuring high-quality patient care for the primary immune deficiency population. Additionally, the product is distributed by specialty distributors across the United States.

Dr. Lisa Betts, Chief Operating Officer for GC Biopharma USA, Inc., highlighted that ALYGLO adds to the treatment options available to patients, thereby improving access within the U.S. market. She reiterated the company's dedication to providing life-saving therapies for rare diseases and expressed enthusiasm about offering another therapeutic option for the primary immune deficiency population.

ALYGLO is a liquid solution containing 10% immunoglobulin G for intravenous infusion, derived from pooled human plasma from U.S. donors. The manufacturing process includes several steps to minimize the risk of virus transmission, such as fractionation, solvent/detergent treatment, and nanofiltration. Additionally, ALYGLO uses a novel Cation Exchange Chromatography (CEX) technique to eliminate FXIa to undetectable levels.

Primary Humoral Immunodeficiency (PI) encompasses disorders in which antibody production is compromised, affecting the immune system's ability to fight infections. This condition involves a deficiency or absence of B cells or plasma cells, responsible for antibody production, leading to increased susceptibility to infections, particularly in the respiratory and gastrointestinal tracts. ALYGLO's PI indication includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

GC Biopharma Corp., formerly known as Green Cross Corporation, is a biopharmaceutical company renowned for delivering life-saving protein therapeutics and vaccines. Based in Yongin, South Korea, GC Biopharma has been a leading global manufacturer of plasma protein and vaccine products for over half a century, committed to providing quality healthcare solutions.

GC Biopharma USA, Inc., established in Teaneck, NJ, in 2018, serves customers and patients throughout the U.S. Building on the expertise of its parent company, GC Biopharma USA aims to extend its reach and bring its legacy of plasma therapies and vaccines to the U.S. market.