– Secures approval for ‘Hunterase IV’ in India and both ‘Hunterase IV & ICV’ in Taiwan, accelerating expansion into the Asian rare disease market

YONGIN, South Korea, Aug. 24, 2026 /PRNewswire/ — GC Biopharma (006280.KS), a leading global pharmaceutical company based in South Korea, announced today that its Hunter syndrome treatment, ‘Hunterase IV’, has received marketing authorization from India’s Central Drugs Standard Control Organisation (CDSCO) and Taiwan’s Food and Drug Administration (TFDA). Additionally, ‘Hunterase ICV’ (brand name in Taiwan: Irifaze ICV), an intracerebroventricular infusion, has also been approved by the Taiwan TFDA.

With these approvals, Hunterase IV is now authorized in 14 countries worldwide, while Hunterase ICV is approved in 4 countries.

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 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 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. “We will continue to dedicate our efforts to improving the quality of life for patients worldwide.”

Hunter syndrome is a rare congenital disorder caused by a deficiency in lysosomal enzymes that break down glycosaminoglycans (GAGs). This deficiency leads to skeletal abnormalities, cardiac dysfunction, and cognitive decline. It predominantly affects males, occurring in approximately 1 in 100,000 to 150,000 live male births.

Hunterase ICV delivers the therapeutic enzyme directly into the cerebral ventricles, effectively bypassing the blood-brain barrier (BBB) into the central nervous system (CNS). This approach aims to manage symptoms associated with CNS damage, including cognitive decline. Approximately 70% of all Hunter syndrome patients suffer from severe forms of the disease accompanied by CNS impairment.

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo^®(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/

This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma’s management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.

GC Biopharma Contacts (Media)

Sohee Kim
shkim20@gccorp.com

Yelin Jun
yelin@gccorp.com

Yoonjae Na
yjy6520@gccorp.com

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SOURCE GC Biopharma