Green Cross Gains Market Approval With the World's 2nd Orphan Drug for Hunter Syndrome in South Korea
Green Cross is emerging as a potent global player in rare disease ground with its orphan drug, Hunterase®, capturing market green light from Korean FDA. Hunterase® is a human recombinant iduronate-2-sulfatase (IDS) designed to replace the enzyme that is deficient or absent in people with Hunter Syndrome. Prior to the approval, the only available drug was Shire’s drug, Elaprase, which now faces the fresh competition from Green Cross.
In collaboration with Samsung Medical Centre in Korea, Green Cross made it to the regulatory finish line after a 24-week, randomized, active-controlled clinical trial. The study demonstrated that Hunterase® reduces urinary glycosaminoglycans (GAGs) excretion by 30–40% and improves the 6-minute-walk distance by 19% from baseline after 24 weeks of weekly treatment; a significant improvement over the positive control drug. Safety evaluation also showed that patients treated with Hunterase experienced fewer side effects than those given the positive control drug, and treatment with Hunterase® for 24 weeks did not induce the production of antibodies against IDS.
“Market approval for Hunterase® has opened a new paradigm for patients suffering from Hunter Syndrome, offering a distinct therapeutic alternative with improved efficacy and safety” stated E.C Huh, the CTO of Green Cross. “On the basis of this approval, we are poised to accelerate the introduction of Hunterase® into larger geographic areas, including major markets such as the North America, Europe and China, as well as emerging markets”.
Presently, Green Cross is focused on expanding its presence towards bigger markets throughout global partnering. The current Hunter syndrome market is worth $450 million USD globally, with double-digit annual growth rates.
About Hunter syndrome
Hunter syndrome (or mucopolysaccharidosis Type II) is a rare genetic disorder that interferes with the body’s ability to break down specific mucopolysaccharides, known as GAGs, due to a single deficiency in a lysosomal enzyme, IDS. The disease leads to serious symptoms, including developmental delay, short stature, skeletal deformities, airway obstruction, and a decreased range of joint motion, and eventually to death at around the age of 15. The occurrence is 1 in 100,000–150,000 male worldwide.
About Green Cross Corp.
Green Cross Corp. is a leading, publicly traded Korean biopharmaceutical company that specializes in the development and commercialization of vaccines, plasma-derivatives, recombinant proteins and therapeutic antibodies for use in the fields of oncology and infectious diseases.