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YONGIN, South Korea– LA-GLA is an investigational therapy for the treatment of Fabry disease, which is being co-developed by GC Biopharma and Hanmi Pharmaceutical. The clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LA-GLA in patients with Fabry disease.

Fabry disease is a rare genetic disorder linked to the X chromosome and classified as a type of Lysosomal Storage Disease (LSD). It results from a deficiency in the enzyme alpha-galactosidase A, which is essential for breaking down glycolipids in lysosomes. The accumulation of glycolipids due to this deficiency can lead to progressive damage to multiple organs and severe outcomes, including death.

Current treatment for Fabry disease includes Enzyme Replacement Therapy (ERT), which involves the intravenous administration of a recombinant enzyme. Additional treatment options may help address patient and provider needs.

As a once-monthly subcutaneous investigational therapy, LA-GLA has been designed with the goal of improving treatment delivery. Preclinical studies conducted to date have demonstrated the therapy's pharmacological activity, including kidney function improvements and effects on other disease manifestations. Based on these findings, the FDA granted LA-GLA Orphan Drug Designation (ODD) in May 2024.

GC Biopharma and Hanmi Pharmaceutical commented: "This collaboration reflects our shared commitment to advancing therapeutic options for rare diseases. By leveraging the technical expertise of both companies, we aim to execute this clinical trial efficiently and generate data to support the development of LA-GLA as a potential treatment for Fabry disease."

About GC Biopharma Corp.

GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century.

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