医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

CANbridge Pharmaceuticals’ Hunterase® Granted Priority Review by the Chinese National Medical Products Administration

2019年09月10日 PM09:02
このエントリーをはてなブックマークに追加


 

BEIJING & SHANGHAI

CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, announced that the National Medical Products Administration (NMPA) of China granted Priority Review to Hunterase (idursulfate beta), a human recombinant iduronate-2-sulfatase (IDS) enzyme replacement therapy, for the treatment of Hunter syndrome (mucopolysaccharidosis type II). Hunter syndrome is a rare, disabling and life-threatening genetic disease, which has a higher prevalence in Asia than in other parts of the world. CANbridge recently submitted a Hunterase New Drug Application (NDA) to the NMPA. The Chinese government has included mucopolysaccharidosis on the “First National List of Rare Diseases” as a disease group to target. There is no approved treatment for Hunter syndrome in China.

“The Priority Review designation, solely granted to therapies that address unmet medical conditions with some level of clinical urgency, validates our choice of Hunterase as the first rare disease candidate we plan to commercialize,” said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. “Hunterase is approved in 10 countries. We are now one step closer to being able to bring the same treatment option to Hunter syndrome patients, and their families, in China.”

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 countries. The rate in East Asian countries, however, is higher, occurring in approximately 1 in 51,000 to 93,000 live births in Taiwan. 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 government.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20190910005129/en/

CONTACT

CANbridge Pharmaceuticals Inc.

James Xue

CEO

+8610.8414.8018

781.995.0074

Media

Deanne Eagle

Planet Communications

deanne@planetcommunications.nyc

917.837.5866

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • 知临集团用于治疗神经母细胞瘤的再利用药物 SACT-1 获得FDA孤儿药资格
  • シャーロット・ディーン教授がバイオ医薬品AI担当主任科学者としてエクセンシアに参加
  • Charlotte Deane教授加入Exscientia,担任生物制剂人工智能首席科学家
  • Elpiscience Announces First Patient Dosed in US Phase I Clinical Trial of Anti-CD39 Monoclonal Antibody ES002 for Treatment of Advanced Solid Tumors
  • CDISC Welcomes New Members to Board of Directors