Clinigen K.K. and GC Pharma Announce Exclusive Licensing Agreement in Japan for Hunterase (Idursulfase-beta) ICV, Hunter Syndrome Drug

YONGIN,South Korea,April 4,2019 -- Clinigen K.K. and GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280) today announced an exclusive licensing agreement in Japan to commercialize Hunterase (Idursulfase-beta) ICV,a human recombinant iduronate-2-sulfatase (IDS) used in enzyme replacement therapy for the treatment of Hunter syndrome. Used as one of the methods for Hunter syndrome treatment,intravenous injection does not penetrate the blood brain barrier in clinically adequate amounts. Hunterase (Idursulfase-beta) ICV developed by GC Pharma is delivered directly to cerebral ventricles by intracerebroventricular (ICV) administration,in order to reach the cells of the brain and central nervous system. Hunterase (Idursulfase-beta) ICVis expected to meet the unmet needs of severe patients in improving their quality of life,as a method that can achieve what previous intravenous injection could not. The Phase 1/2 clinical trial conducted as an investigator-initiated trial by Prof. Torayuki Okuyama in National Center for Child Health and Development in Japan showed a significant decrease in Heparan sulfate which causes mental retardation.

[Image] Clinigen K.K. and GC Pharma announced an exclusive licensing agreement in Japan to commercialize Hunterase (Idursulfase-beta) ICV.

"We are proud to bring this innovative treatment to Japanese patients through the partnership with GC Pharma," said Yoshikazu Nakamura,Representative Director at Clinigen K.K.. "Hunter Syndromeis a complex disease with unmet medical need. We earnestly hope that this product provides significant benefit to patients in Japan."

"We are delighted to further enhance the value of Hunterase through this partnership," said Eun Chul Huh,Ph.D.,President at GC Pharma. "Our efforts to make substantial differences in the lives of those with Hunter syndrome in all markets will continue by providing new treatment environments and opportunities.

About Hunter syndrome

Hunter syndrome(Mucopolysaccharidosis type II) is an inherited lysosomal storage disease that occurs primarily in boys. It causes an enzyme deficiency that interferes with the body's ability to break down certain complex sugars,resulting in serious skeletal,tissue,neurological and multi-organ complications and,ultimately,death. It occurs in approximately 1.3 out of 100,000 male newborns. There is no cure. The standard treatments are enzyme replacement therapy (ERT) or palliative care.

About GC Pharma

GC Pharma is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea,GC Pharma is one of the largest protein products manufacturers in the world and has been dedicated to quality healthcare solutions more than half a century. Green Cross Corporation updates its corporate brand as GC Pharma in early 2018. Green Cross Corporation remains the company's registered,legal name.

About Clinigen K.K.

Clinigen K.K. is a wholly owned subsidiary of Clinigen Group plc,global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines,based in Burton Upon Trent,UK. Clinigen K.K. focuses on the development and commercialization of medicines for rare diseases.

In collaboration with Link Healthcare K.K. (Clinigen Group),Clinigen K.K. provides ethical and timely access to licensed and unlicensed medicines to improve the quality of people's lives in Japan.

For more on Clinigen K.K. please visit www.clinigen.co.jp

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