GC Green Cross Obtains Product Approval in Peru for Hunter Syndrome Treatment "Hunterase ICV"

Expansion into Central and South American Markets

Global Growth Expected Based on Clinical Value

GC Green Cross has obtained product approval in Peru for its intraventricularly administered Hunter syndrome treatment, "Hunterase ICV." This marks the company's third overseas approval following Japan and Russia.

GC Green Cross announced on the 6th that Peru's Directorate General of Medicines, Supplies and Drugs (DIGEMID) has approved Hunterase ICV. The company also stated that it is pursuing entry into additional countries, including those in Central and South America.

Hunterase ICV is a Hunter syndrome treatment that delivers the drug directly into the ventricles of the brain and is administered once a month. It was developed for severe patients with Hunter syndrome who experience central nervous system symptoms.

Hunter syndrome is a rare genetic disorder caused by a deficiency of the IDS (Iduronate-2-sulfatase) enzyme, resulting in the accumulation of glycosaminoglycans (GAG) in the body. In some patients, central nervous system damage occurs, leading to cognitive decline and behavioral abnormalities.

According to GC Green Cross, clinical trials conducted in Japan showed that Hunterase ICV reduced the levels of heparan sulfate, which is known to be a major causative factor of central nervous system damage. Long-term follow-up observations also revealed a tendency for patients' cognitive and developmental functions to be stably maintained or improved.

Lee Jaewoo, Head of Development at GC Green Cross, stated, "Based on the secured long-term clinical data, we will focus on addressing the unmet medical needs of patients with severe Hunter syndrome."

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