[Provided by Green Cross]
[Provided by Green Cross]

Green Cross's rare disease treatment Hunteraze has secured regulatory approvals in India and Taiwan in quick succession, accelerating the drug's global expansion into key Asian markets.

Green Cross announced Monday that its Hunter syndrome treatment Hunteraze IV had received product approval from India's Central Drugs Standard Control Organisation and Taiwan's Food and Drug Administration. The company's intracerebroventricular formulation, Hunteraze ICV, also received approval from Taiwan's FDA at the same time.

Hunteraze IV has now been approved in 14 countries worldwide, while Hunteraze ICV holds approvals in four. India represents a market with significant unmet medical need and growth potential, as a low proportion of patients there currently receive treatment. Taiwan, meanwhile, is regarded as a highly accessible market thanks to its well-established systems for early patient screening and support.

With the additions of India and Taiwan, Green Cross has further consolidated its position in Asia's rare disease market, following earlier approvals in Japan, China and Malaysia.

Hunter syndrome is a congenital rare disease caused by a deficiency of the lysosomal enzyme that breaks down glycosaminoglycans, leading to skeletal abnormalities, cardiac dysfunction and cognitive decline. About 70 percent of patients worldwide suffer central nervous system damage. Hunteraze ICV addresses this by delivering the drug directly to the brain's ventricles to help improve cognitive function.

The approvals extend the drug's reach in large, emerging Asian markets where treatment options have been limited — covering not only the intravenous formulation but also the intracerebroventricular form — strengthening Green Cross's supply chain and commercial competitiveness in the global rare disease treatment market.

"These approvals are meaningful in that they can address the unmet medical needs of patients in Asia who have had limited treatment options," said Lee Jae-woo, head of Green Cross's development division. "We will continue to do our best to contribute to improving the quality of life for patients."


silverpaper@heraldcorp.com