GC Biopharma wins India, Taiwan approvals for Hunterase rare-disease treatment

GC Biopharma said India’s Central Drugs Standard Control Organisation and Taiwan’s Food and Drug Administration approved Hunterase IV, its intravenous treatment for Hunter syndrome. Taiwan also approved Hunterase ICV, an intracerebroventricular infusion marketed there as Irifaze ICV. The decisions bring Hunterase IV’s authorization to 14 countries and Hunterase ICV’s to four. India has high unmet medical needs because relatively few patients receive existing treatments, while Taiwan has established systems for early screening and patient support. GC Biopharma, formerly known as Green Cross Corporation, plans to build on its presence in Japan, China and Malaysia as it expands in the global rare-disease market.

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