GC Biopharma submitted an application for domestic approval of the Hunter syndrome treatment 'Hunterraze ICV' to the Ministry of Food and Drug Safety on the 29th. Hunter syndrome is a rare genetic disorder characterized by skeletal abnormalities, cognitive impairment, and central nervous system damage.
Hunterraze ICV is administered by inserting a device into the patient's head to periodically deliver medication to the ventricles. It improves the limitations of intravenous injections that cannot pass through the blood-brain barrier. Hunterraze ICV received designation as a rare drug in Korea last February, making it the fourth such designation after Japan, Russia, and Europe.
Heo Eun-cheol, CEO of GC Biopharma, noted, "I hope this contributes to meeting the medical needs of patients with Hunter syndrome in Korea."