GC Biopharma Wins India, Taiwan Approvals
‘Hunterase’, a treatment for Hunter syndrome developed by GC Biopharma, has successively obtained product approval in major Asian countries India and Taiwan.GC Biopharma announced on August 24 that it received product approval for ‘Hunterase IV’ from the Central Drugs Standard Control Organisation (
GC Biopharma has secured product approvals in India and Taiwan for 'Hunterase IV', a treatment for Hunter syndrome. The Central Drugs Standard Control Organisation (CDSCO) granted approval in India, while the Taiwan Food and Drug Administration (TFDA) approved both 'Hunterase IV' and the direct intracerebroventricular administration formulation, 'Hunterase ICV'.
The latter expansion of treatment options is particularly significant for Taiwan, where early screening and patient support systems are well-established. Hunter syndrome, a rare congenital disorder, affects approximately 1 in 100,000 to 150,000 male children, with about 70% classified as severe cases suffering from central nervous system damage.
GC Biopharma's head of development, Lee Jae-woo, emphasized that the approval addresses unmet medical needs for patients in Asia.
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