GC Biopharma and Hanmi Pharmaceutical Receives IND Clearance for Phase 1/2 Clinical Trial from the U.S. FDA

• Co-development of innovative new drug for the treatment of Fabry disease as "the world's first once-monthly subcutaneous treatment"
• Improves efficacy compared to existing treatment for kidney function, vascular disease, and peripheral nerve disorders

YONGIN, South Korea, Sept. 3, 2024 /PRNewswire/ -- GC Biopharma announced that its collaborative project for Fabry treatment 'LA-GLA' (GC1134A/HM15421) with Hanmi Pharmaceutical has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial.

LA-GLA is an innovative new drug for the treatment of Fabry disease as the world's first once-monthly subcutaneous treatment, which is being co-developed by GC Biopharma and Hanmi Pharmaceutical. This clinical trial aims to evaluate 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 leads to cellular toxicity and inflammatory responses, progressively damaging multiple organs and potentially leading to severe outcomes, including death.

Currently, Fabry disease is treated with Enzyme Replacement Therapy (ERT) which involves the intravenous administration of a recombinant enzyme. However, this treatment method requires patients to visit the hospital every two weeks for an infusion, leading to inconvenience. Moreover, the current method has limitations, including the burden of prolonged intravenous therapy and insufficient efficacy in preventing the progression of kidney disease.

LA-GLA is an 'innovative enzyme replacement therapy" addressing the limitations of existing treatments. It significantly improves convenience with a once-monthly subcutaneous injection regimen. In preclinical studies, LA-GLA not only improves kidney function but also demonstrated superior efficacy in managing vascular disease and peripheral nerve disorders compared to existing therapies. Based on these promising results, it was designated as an Orphan Drug (ODD) by the U.S. FDA this past May.

GC Biopharma and Hanmi Pharmaceutical commented, "This collaboration integrates the latest FDA-mandated clinical protocols and leverages the specialized technical expertise of both companies, enabling a rapid transition into the clinical phase." Further added, "Based on our expertise and knowledge of developing new treatments for Lysosomal Storage Disease (LSD), we will do our utmost to create new treatment options to patients suffering from 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.

This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.

GC Biopharma Corp. Contacts (Media)

Sohee Kim
shkim20@gccorp.com

Yelin Jun
yelin@gccorp.com

Rachel Kim
rachel.kim@gccorp.com