GC Green Cross Secures Hunterase Approvals for Hunter Syndrome in India and Taiwan

GC Green Cross announced on August 24, 2026, that Hunterase IV received marketing authorization from India’s Central Drugs Standard Control Organisation (CDSCO) and Taiwan’s Food and Drug Administration (TFDA). Taiwan also approved Hunterase ICV, an intracerebroventricular formulation that delivers the therapy directly into the brain’s ventricular system.

With the latest approvals, Hunterase IV is now authorized in 14 countries worldwide, while Hunterase ICV is approved in four. The company has previously established a presence in major Asian markets including Japan, China, and Malaysia.

India represents a significant market-access opportunity because the proportion of Hunter syndrome patients receiving existing treatments remains low, pointing to substantial unmet medical need. Taiwan has approved both formulations and has established systems for early Hunter syndrome screening and patient support, factors that may facilitate access to treatment.

Hunter Syndrome and the Role of Enzyme Replacement

Hunter syndrome, or mucopolysaccharidosis type II (MPS II), is an X-linked lysosomal storage disorder caused by deficient activity of iduronate-2-sulfatase (IDS). The enzyme normally participates in the degradation of the glycosaminoglycans (GAGs) heparan sulfate and dermatan sulfate. Loss of IDS activity causes progressive GAG accumulation in tissues and organs, contributing to multisystem disease.

The disorder predominantly affects males and can cause skeletal abnormalities, cardiovascular dysfunction, organ involvement, and neurological impairment, including cognitive decline. The source estimates an incidence of approximately 1 in 100,000 to 150,000 male births.

Hunterase IV provides enzyme replacement through intravenous administration, addressing the systemic manifestations of the disease. However, recombinant IDS delivered intravenously has limited ability to cross the blood-brain barrier, which restricts its ability to address neurological disease within the CNS.

ICV Formulation Targets CNS Involvement

Hunterase ICV uses direct intracerebroventricular administration to deliver the therapeutic enzyme into the CNS, bypassing the blood-brain barrier. The approach is intended to address manifestations associated with CNS involvement, including cognitive decline.

The distinction is clinically important because CNS involvement represents a major component of severe Hunter syndrome. GC Green Cross reports that approximately 70% of patients worldwide have severe disease accompanied by CNS damage.

The Taiwan approval therefore expands access to both systemic enzyme replacement and a formulation specifically administered to the CNS, giving the market access to two approaches within the Hunterase franchise.

Hunterase Advances Across Asian Markets

Lee Jae-woo, head of development at GC Green Cross, said the approvals are meaningful because they can address unmet medical needs among Asian patients who previously lacked sufficient treatment options. He added that the company will continue efforts to improve patients’ quality of life.

The approvals strengthen GC Green Cross’s position across Asia while extending Hunterase’s international regulatory footprint. The company plans to continue expanding its presence in the global rare-disease therapeutics market, with India and Taiwan adding two strategically important markets to its existing Asian operations.

Reference

GC Green Cross Obtains Product Approval for Hunter Syndrome Treatment ‘Hunterrase’ in India and Taiwan