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CANbridge Pharmaceuticals Submits New Drug Application for Hunterase® for the Treatment of Hunter Syndrome in China

2019年07月29日 PM09:02
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BEIJING & SHANGHAI

CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, announced that it has filed a New Drug Application (NDA) with the National Medical Products Administration (NMPA) for Hunterase (idursulfase beta), a human recombinant iduronate-2-sulfatase (IDS) enzyme replacement therapy, to treat Hunter Syndrome in China. Hunter Syndrome (mucopolysaccharidosis type II) is a rare, disabling and often fatal genetic disease that occurs more frequently in Asian than in Western countries1-4. Hunterase has been available for the treatment of Hunter syndrome in 10 countries. CANbridge licensed Hunterase from its developer, GC Pharma (KRX: 006280), earlier this year for development and commercialization in greater China. The Chinese government has included mucopolysaccharidosis on the “First National List of Rare Diseases” as a disease group to target5. Currently, there is no approved treatment in China.

“We are delighted to submit the Hunterase NDA, which includes data from the first enzyme replacement therapy trial in Chinese patients to the NMPA, so soon after having licensed the treatment in January,” said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. “We look forward to bringing Hunterase, the first rare disease drug that CANbridge plans to commercialize in China, to Hunter syndrome patients and their families, for whom there are no treatment options in China, other than palliative care.”

About Hunter syndrome

Hunter syndrome (MPS II) is an inherited lysosomal storage disease that is X-linked and occurs primarily in boys. It causes an enzyme deficiency that interferes with the body’s ability to break down certain complex sugar polymers called glycosaminoglycans, resulting in serious skeletal, tissue, neurological and multi-organ complications and, ultimately, a shortened lifespan. Hunter syndrome occurs in approximately 1 in every 149,000 to 162,000 live births in Caucasian countries1,2. The rate in East Asian countries, however, is higher, occurring in approximately 1 in 51,000 to 93,000 live births in Taiwan3,4. There is no cure currently. The standard treatments are enzyme replacement therapy (ERT) or palliative care. Mucopolysaccharidosis is one of the 121 diseases on the “First National List of Rare Diseases” published by the Chinese government5.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a China-based biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address medical needs that are underserved in the region.

CANbridge has been widely recognized as a leader in orphan diseases in China. It has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In addition, it has an exclusive licensing agreement to commercialize Hunterase®, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than ten countries worldwide. CANbridge also has an oncology portfolio, which includes exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib), approved in the US, and rights to other novel candidates.

For more on CANbridge Pharmaceuticals Inc., please go to www.canbridgepharma.com

References:

  1. Meikle PJ, et al. JAMA. 1999; 281: 249-54.
  2. Poorthuis BJ, et al. Hum Genet. 1999; 105: 151-156.
  3. Lin HY, et al. Am J Med Genet 2009; 149A: 960-964.
  4. Chuang CK, et al. Orphanet J Rare Dis. 2018; 13: 84.
  5. The list of 121 rare diseases jointly released by the five departments of the national health commission in May 2018.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20190729005166/en/

CONTACT

CANbridge Pharmaceutical Inc.

James Xue

CEO

+8610.8414.8018

781.995.0074

Media

Deanne Eagle

Planet Communications

deanne@planetcommunications.nyc

917.837.5866

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