The Central Drugs Standard Control Organisation in India has granted marketing authorization for the intravenous formulation, Hunterase IV. Simultaneously, Taiwan’s Food and Drug Administration approved both the IV version and the intracerebroventricular infusion, marketed locally as Irifaze ICV. These additions bring the total global reach of Hunterase IV to 14 countries, while the specialized ICV formulation is now authorized in four.

Hunter syndrome, a rare congenital condition caused by enzyme deficiency, often results in severe skeletal, cardiac, and cognitive impairment. Because roughly 70% of patients experience central nervous system damage, the ICV treatment is particularly vital; it bypasses the blood-brain barrier to deliver enzymes directly into the cerebral ventricles. Eun-Chul Huh, CEO of GC Biopharma, noted that these approvals provide a critical path forward for patients who previously faced a lack of sufficient therapeutic options. By entering these regions, the company builds upon its existing footprint in Japan, China, and Malaysia, further solidifying its role in the global rare disease sector.