GC said that CANBridge Pharmaceuticals, its Chinese partner, has applied for the sales approval of Hunterase, a Hunter syndrome drug, to China’s National Medical Products Administration (NMPA).
|GC headquarters in Yongin, Gyeonggi Province.|
The application came six months after the two companies signed a licensing agreement, which gave CANbridge the exclusive rights to develop and commercialize Hunterase in the greater China area.
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.
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.
“The application is meaningful as it marks the first step toward treating patients with Hunter syndrome in China,” 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, “We are glad to apply for the sales approval of Hunterase as the first enzyme replacement therapy for Chinese patients.”
Hunterase is a human recombinant iduronate-2-sulfatase (IDS) enzyme replacement therapy for treating Hunter syndrome. The company is marketing the product in more than 10 countries.
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