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- 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 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 [email protected] Yelin Jun [email protected] Yoonjae Na [email protected] SOURCE GC Biopharma 21% more press release views with Request a Demo

SUZHOU, CHINA, 7 August 2026 – CANbridge Pharmaceuticals Inc. (“CANbridge” or the “Company”, Stock Code: 1228.HK), a global biopharmaceutical company focused on rare diseases, is committed to the research, development and commercialization of innovative therapies. The Company announces that Dr. Richard Arthur Moscicki (“Dr. Moscicki”) has been appointed as an independent non-executive Director, the chairman of the Remuneration Committee and a member of the Audit Committee. Dr. Moscicki currently serves as a director of the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), a member of the executive committee of Equitable Breakthroughs in Medicine Development at Yale University, chairman of the board of the Clinical Trials Access Collaborative, and a director of KSQ Therapeutics. With over five decades of integrated experience, he possesses extensive cross-sector expertise spanning clinical, biotech, regulatory and academic fields. As a trailblazer, he has led and contributed to the evolution of the rare disease industry from early stage to full bloom. On the regulatory front, Dr. Moscicki once held the dual roles of executive vice president of the science and regulatory advocacy and chief medical officer at Pharmaceutical Research and Manufacturers of America (PhRMA). He also acted as the deputy center director for science operations at the FDA’s Center for Drug Evaluation and Research (CDER). Within the biotech sector, Dr. Moscicki spent more than two decades at Genzyme Corporation (formerly Nasdaq: GENZ), a rare-disease trailblazer later acquired by Sanofi, and occupied core senior posts including chief medical officer. He has sat on the boards of multiple biotech firms, namely LogicBio Therapeutics, Inc. (formerly Nasdaq: LOGC) and Akcea Therapeutics, Inc. (formerly Nasdaq: AKCA). In clinical practice, Dr. Moscicki spent three decades at Massachusetts General Hospital as an attending physician and assistant director specialising in allergy and immunology. Dr. Moscicki holds a Bachelor of Science degree from Northwestern University and a Doctor of Medicine degree from Northwestern University Medical School under the Honor Program in Medical Education. “We are extremely honoured to welcome Dr. Moscicki, a towering pioneer and a visionary leader of the biotech industry, to the Board”, said James Xue, Ph.D., Founder, Chairman and CEO of CANbridge, “Dr. Moscicki is one of the most accomplished physician-scientists who embodies the highest standard in drug development and regulatory science, especially in the rare disease space. During my earlier career at Genzyme, I had the fortune to work with and for Rich, who served as my role model and mentored me in patient-centricity and scientific integrity.” Dr. Moscicki stated: “I am delighted to join CANbridge’s Board of Directors at a very critical time for the global rare disease industry and for CANbridge as it pivots to a global expansion strategy. This is far more than a professional appointment. For me, it is a genuine homecoming. James and I worked together for over a decade at Genzyme, a trailblazer in the modern rare‑disease field. The core values that defined Genzyme, innovation, entrepreneurship, and patient‑first, are all practiced and cherished at CANbridge. I look forward to working with James and other board members, grounding our foundation in China while pursuing world-class innovation guided by the global regulatory framework, and continuously pushing for expanded patient access to life‑changing rare‑disease therapies.” Dr. Moscicki succeeded Dr. Richard Gregory, who recently retired from the CANbridge Board. “As an independent director, Dr. Gregory had been an instrumental voice on the Board guiding CANbridge navigate through the IPO launch, pipeline development and the challenges over the past six years. I am eternally grateful to Dr. Gregory for his guidance and partnership and wish him a very fulfilling time in his retirement,” said James Xue. About CANbridge CANbridge Pharmaceuticals Inc. (Stock Code: 1228.HK) was founded in 2012 and listed on the Main Board of HKEX in 2021. The Company is a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases. As of December 31, 2025, the Company has a comprehensive pipeline of 7 drug assets targeting prevalent rare diseases that have high unmet needs and significant market potential. The robust pipeline includes 3 marketed products (Hunterase® , Livmarli® , Gaurunning® ) and 1 drug candidate at the late clinical stage, covering biologics, small molecules and gene therapies. In the rare disease area, the Company currently has seven biologic and small molecule product candidates. These include MPS II (Hunter syndrome) and other lysosomal storage disorders (LSDs), complement-mediated disorders, hemophilia A, metabolic disorders and rare cholestatic liver diseases including Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Furthermore, CANbridge is investing in the R&D of next-generation gene therapy technologies, which will provide novel, potentially curative therapies for rare genetic diseases with limited treatment options. To support the research, development and commercialization of its pipeline, the Company has built a global partner network including, but not limited to, WuXi AppTec, WuXi Biologics, Baheal Medical, GC Pharma, Mirum, Privus and Scriptr Global.