Key Highlights:
- GC Biopharma has received CDSCO approval in India and TFDA approval in Taiwan for Hunterase IV, its intravenous treatment for Hunter syndrome. Hunterase IV is now approved in 14 countries, expanding access in markets with significant unmet needs.
- Taiwan has also approved Hunterase ICV (Irifaze ICV), an intracerebroventricular formulation designed to deliver the enzyme directly into the brain by bypassing the blood-brain barrier. The approval expands Hunterase ICV’s reach to four countries.
- The approvals strengthen GC Biopharma’s presence across key Asian markets, including Japan, China, Malaysia, India and Taiwan, as it seeks to expand its rare disease portfolio globally. Hunter syndrome is a rare disorder caused by deficiency of enzymes needed to break down glycosaminoglycans, leading to skeletal, cardiac and neurological complications.
Implications:
GC Biopharma’s Hunterase IV (idursulfase) has now been approved in India (CDSCO) and Taiwan (TFDA), bringing the intravenous enzyme replacement therapy for Hunter syndrome (MPS II) to 14 countries and strengthening GC’s footprint across key Asian markets (Japan, China, Malaysia, India, Taiwan). 1078 Taiwan also approved Hunterase ICV (Irifaze ICV), an intracerebroventricular formulation that delivers enzyme directly into the brain to address neurological symptoms, expanding ICV approvals to four countries and differentiating GC’s portfolio in a rare disease where CNS involvement is a major unmet need.
Source: PRnewswire
