GC Pharma receives nod in Japan for HunteraseGC Pharma said Wednesday that Clinigen, its Tokyo-based partner, applied for sales approval in Japan for its Hunter syndrome treatment candidate.
Hunterase ICV earned categorization as a treatment option for unmet medical needs, GC Pharma said. At the moment, there is no known cure for Hunter Syndrome, which is characterized by skeletal, tissue, neurological and multi-organ complications resulting from a lack of certain enzymes.
The inherited lysosomal storage disease occurs in around 1.3 out of 100,000 male newborns.
Clinigen signed an exclusive licensing agreement in Japan for GC Pharma’s candidate therapy last year.
According to GC Pharma, Hunterase ICV showed in clinical trials that the amount of heparin sulfate, a primary substance responsible for the disease, was significantly reduced, and development disorder symptoms were alleviated.
By Ko Jun-tae