GC Green Cross has expanded its reach in the Asian market by obtaining regulatory approval for its Hunter Syndrome treatment, Hunterraze IV, in India and Taiwan.
The company announced that Hunterraze IV received approval from the Central Drugs Standard Control Organization (CDSCO) in India and the Taiwan Food and Drug Administration (TFDA). Additionally, the intraventricular formulation, Hunterraze ICV, has also been approved by the TFDA in Taiwan.
With this approval, Hunterraze IV is now authorized in 14 countries worldwide, while Hunterraze ICV has received approval in four countries.
Hunter Syndrome is a rare congenital disorder caused by a deficiency of lysosomal enzymes that break down glycosaminoglycans (GAGs), leading to skeletal abnormalities, cardiac dysfunction, and cognitive decline. It primarily affects males, occurring in approximately 1 in 100,000 to 150,000 births, and severe cases can result in death before adulthood, making early diagnosis and treatment crucial. Currently, the main treatments for Hunter Syndrome globally are GC Green Cross's Hunterraze and Takeda Pharmaceutical's Elaprase.
The Hunterraze ICV is designed for direct delivery into the ventricles of the brain, aiming to improve symptoms related to central nervous system damage, including cognitive decline. About 70% of Hunter Syndrome patients worldwide are known to have severe cases accompanied by central nervous system damage.
India is considered a significant market due to its low percentage of patients receiving existing treatments, indicating a high unmet medical need. Taiwan has approved both IV and ICV formulations and has established early screening and patient support systems for Hunter Syndrome, enhancing market accessibility.
Lee Jae-woo, head of the development division at GC Green Cross, stated, "This approval is significant as it addresses the unmet medical needs of Asian patients who have had limited treatment options. We will continue to strive to improve the quality of life for patients with rare diseases."
* This article has been translated by AI.
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