GC Green Cross Applies for Domestic Marketing Authorization of "Hunterase ICV"

Significant Reduction of Key Substance Responsible for Central Nervous System Damage

GC Green Cross announced on August 29 that it has submitted a domestic marketing authorization application for the intracerebroventricular (ICV) Hunter syndrome treatment, "Hunterase ICV," to the Ministry of Food and Drug Safety.

Hunter syndrome is a rare inherited lysosomal storage disorder, with approximately 70% of patients classified as severe cases experiencing significant central nervous system damage. GC Green Cross succeeded in developing the world's first ICV formulation to address the unmet medical needs of this patient group.

Hunterase ICV is a treatment in which a device is implanted in the patient's head and the drug is periodically administered directly into the brain ventricles. Its key advantage is overcoming the limitations of intravenous drugs that cannot cross the blood-brain barrier.

In clinical trials conducted in Japan, Hunterase ICV significantly reduced heparan sulfate, a key substance responsible for central nervous system damage. Based on these results, Hunterase ICV received marketing approval in Japan in 2021. Furthermore, five-year long-term follow-up data from Japan showed that heparan sulfate levels remained low, and cognitive decline was delayed or cognitive function improved.

Heo Euncheol, CEO of GC Green Cross, said, "We hope that this marketing authorization application will help address the unmet medical needs of domestic Hunter syndrome patients," adding, "We expect Hunterase ICV to become a major treatment option for severe patients worldwide."

Meanwhile, Hunterase ICV was designated as an orphan drug by the Ministry of Food and Drug Safety in February of this year, marking the fourth such designation after Japan, Russia, and Europe. Hunterase ICV is currently available in Japan and received marketing approval in Russia in December of last year.

This content was produced with the assistance of AI translation services.