GC said that China’s National Medical Products Administration (NMPA) has designated Hunterase, a Hunter syndrome drug, as a priority screening product.
|GC headquarters in Yongin, Gyeonggi Province.|
The Chinese regulatory agency operates a priority screening system to shorten the review period for innovative medicines and rare diseases in areas where there is no treatment.
The designation comes after CANBridge Pharmaceuticals, its Chinese partner, applied for the sales approval of Hunterase, a Hunter syndrome drug, to NMPA in July. The two companies had signed a licensing agreement, which gave CANbridge the exclusive rights to develop and commercialize Hunterase in the greater China area.
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 severe skeletal, tissue, neurological and multi-organ complications and, ultimately, death.
Hunter syndrome is known to occur in one out of 150,000 people. However, the number of cases is more prevalent in East Asia, with Taiwan having a ratio of one out of about 50,000 to 90,000 people.
For such reasons, the Chinese NMPA included Hunter syndrome in the list of rare disease management last year.
“The company hopes that the priority screening will provide treatment for Hunter syndrome patients in China as soon as possible,” GC President Huh Eun-chul said. “We will continue to innovate to provide a new therapeutic environment for Hunter syndrome patients worldwide.”
CANbridge Pharmaceuticals CEO and Chairman James Xue also said, “Expectations is growing for Hunterase to become the first cure for Hunter syndrome in China.”