Hunterase by GC Pharma is entering the Chinese market

Approved as the first treatment for Hunter syndrome in China

Hunterase by Green Cross is entering the Chinese market GC Pharma announced on the 9th that Hunterase, a treatment for Hunter syndrome, has obtained a license from the NMPA of China.

 

This is the first time that a drug for Hunter syndrome has been approved in China.

 

Hunterase by Green Cross

GC Pharma applied for Hunterase's item license, July of last year in China, and was designated as a priority subject of review by the NMPA in September.

 

The commercialization of Hunterase in China and other China region is undertaken by “CANBridge Pharmaceuticals,” which has signed an export contract.

 

Hunter syndrome, referred to as 'type II mucopolysaccharide', is a rare congenital disease that shows various unpredictable symptoms such as skeletal abnormalities and decreased intelligence, and dies early around 15 years of age.

 

In general, it occurs at the rate of 1 in 150,000 males, and one of the Greater China countries, about 1 in 50,000 to 90,000 cases occurs in Taiwan, and it is known that the incidence rate in East Asian countries is higher.

 

Currently, more than 3,000 patients with Hunter syndrome in China are estimated.

 

GC Pharma developed Hunterase as the world's second hunter syndrome treatment in 2012 and is now supplying it to 11 countries around the world.

 

It is also planning for Hunterase to enter Japanese market.

 

GC Pharma' partner, Clinigen K.K., applied for an item license of 'Hunterase ICV (intracerebroventricular)', a ventricular administration method, to the Japan Pharmaceutical and Medical Device Administration (PMDA) in March.

 

Hunterase ICV is a novel formulation in which drugs are administered directly to the ventricle by inserting a device into the head.

 

ICV has the advantage of overcoming the limitations of existing intravenous formulations that do not improve the symptoms of decreased intelligence because drugs can not penetrate the blood brain barrier (BBB).

 

Eun Chul Huh, President at GC Pharma said, “It is of great significance in that we are able to provide new treatment environments and opportunities for patients with Hunter syndrome in China.

 

I will do my best.” James Xue, CEO of CANbridge, said, "The approval of this product will be an important step forward in our efforts to commercialize the desperately needed treatment for rare diseases in China and around the world."