GC Biopharma's Hunterase wins approval in India and Taiwan, expanding reach in Asia's rare disease market
核心洞察
GC Biopharma (搜索)'s Hunter syndrome (搜索) treatment Hunterase IV received marketing authorization from India's CDSCO and Taiwan's TFDA, while Hunterase ICV (搜索) was also approved in Taiwan.
Hunterase IV is now authorized in 14 countries worldwide, and Hunterase ICV (搜索) holds approvals in four countries, consolidating the company's position in Asia.
India presents high growth potential due to significant unmet medical need, while Taiwan offers high market accessibility through well-established early screening and patient support systems.
GC Biopharma (搜索) (006280.KS), a South Korea-based biopharmaceutical company formerly known as Green Cross Corporation, announced on August 24, 2026 that its Hunter syndrome (搜索) treatment Hunterase has secured regulatory approvals in India and Taiwan in quick succession, accelerating the drug's expansion into key Asian rare disease markets.
Hunterase IV received marketing authorization from India's Central Drugs Standard Control Organisation (CDSCO) and Taiwan's Food and Drug Administration (TFDA). At the same time, Hunterase ICV (搜索) (brand name in Taiwan: Irifaze ICV), an intracerebroventricular infusion, was also approved by Taiwan's TFDA. With these approvals, Hunterase IV is now authorized in 14 countries worldwide, while Hunterase ICV holds approvals in four countries.
Addressing Unmet Need Across Asian Markets
India, which approved the intravenous (IV) formulation, presents high growth potential and significant unmet medical needs, as the proportion of patients currently receiving existing treatments remains low. Taiwan, having approved both the IV and ICV formulations, is recognized for its high market accessibility, supported by well-established systems for early Hunter syndrome (搜索) screening and patient support.
Having successfully established a presence in key Asian markets—including Japan, China, and Malaysia, alongside the latest approvals in India and Taiwan—GC Biopharma (搜索) plans to further expand its footprint in the global rare disease market.
"These approvals are significant as they address the unmet medical needs of local Asian patients who previously lacked sufficient treatment options," said Eun-Chul Huh, CEO of GC Biopharma (搜索). "We will continue to dedicate our efforts to improving the quality of life for patients worldwide."
Disease Background and Mechanism of Action
Hunter syndrome (搜索) is a rare congenital disorder caused by a deficiency in lysosomal enzymes that break down glycosaminoglycans (搜索) (GAGs). This deficiency leads to skeletal abnormalities, cardiac dysfunction, and cognitive decline. The condition predominantly affects males, occurring in approximately 1 in 100,000 to 150,000 live male births.
Approximately 70% of all Hunter syndrome (搜索) patients suffer from severe forms of the disease accompanied by central nervous system (CNS) impairment. Hunterase ICV (搜索) addresses this by delivering the therapeutic enzyme directly into the cerebral ventricles, effectively bypassing the blood-brain barrier (BBB) into the CNS. This approach aims to manage symptoms associated with CNS damage, including cognitive decline.
Strategic Implications
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 GC Biopharma (搜索)'s supply chain and commercial competitiveness in the global rare disease treatment market.
GC Biopharma (搜索) has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with the successful US market entry of Alyglo (intravenous immunoglobulin G) in 2024. The company continues to drive innovation by leveraging its core R&D capabilities in protein engineering, mRNA, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for rare diseases as well as immunology and inflammation.