GC녹십자 Wins Peru Approval for Hunter Syndrome Drug Hunterase ICV

GC Green Cross, which is nearing the 2 trillion won revenue mark, has secured marketing approval in Peru for its intraventricular Hunter syndrome treatment, Hunterase ICV, following approvals in Japan and Russia, the company said. The move supports its push to expand overseas sales and diversify exports as it focuses on high value-added products in advanced markets such as the United States and Japan while accelerating entry into emerging markets. 

The company said Tuesday that Peru’s drug regulator, DIGEMID, recently granted approval for Hunterase ICV.

Hunterase ICV is administered directly into the brain’s ventricles and is given once a month. In clinical trials conducted in Japan, the treatment significantly reduced heparan sulfate, a key substance linked to central nervous system damage. It also showed effects in improving or stabilizing developmental age, a measure used to assess patients’ intellectual and physical development.

Lee Jae-woo, head of development at GC Green Cross, said, “Based on long-term clinical data, we will work to address unmet medical needs in severe Hunter syndrome.”

Hunter syndrome is a congenital rare disease in which a deficiency of the IDS enzyme causes glycosaminoglycans (GAG) to accumulate in the body. Symptoms include skeletal abnormalities, joint deformities, respiratory and cardiac dysfunction, and cognitive decline. It is known to occur in about one out of every 100,000 to 150,000 boys.

About two-thirds of patients are believed to have a severe form accompanied by central nervous system damage. As the disease progresses, cognitive decline and behavioral abnormalities can appear, significantly affecting quality of life and prognosis. 

GC Green Cross posted record annual revenue of 1.9913 trillion won last year. Market observers say the company has a strong chance of surpassing 2 trillion won this year as its core businesses, including blood products and vaccines, are expected to grow.