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 CANbridge Pharmaceuticals CAN106 Investigational New Drug Application Approved in Singapore for the Treatment of Complement Dysregulation Diseases

2020年12月18日 PM10:02
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BEIJING & CAMBRIDGE, Mass.

CANbridge Pharmaceuticals Inc., a company developing and commercializing innovative drugs to treat rare diseases and targeted cancers, announced that its Investigational New Drug (IND) application for CAN106, a recombinant human monoclonal antibody targeting complement C5 of the complement system, has been approved by the Health Sciences Authority (HSA) in Singapore for the treatment of complement dysregulation diseases. The first indication is paroxysmal nocturnal hemoglobinuria (PNH), a fatal disease in which the complement system destroys red blood cells.

CAN106 is being developed for multiple diseases associated with complement dysregulation. The complement system is the part of the immune system that helps antibodies and phagocytic cells clear microbes and damaged cells. Dysregulation of the proteins that compose it leads to several rare diseases, including PNH. CANbridge holds the proprietary global rights to research, develop, manufacture, and commercialize CAN106. CANbridge is developing CAN106, in conjunction with WuXi Biologics (2269.HK), a global company with leading open-access biologics technology platforms, as part of a strategic partnership for the development of rare disease therapeutics.

“This, the first IND approval to come out of our collaborative rare disease partnership with WuXi Biologics, marks another major milestone for CANbridge,” said James Xue, PhD, CANbridge Founder, Chairman and CEO. “CAN106 is the first CANbridge global proprietary asset to enter into clinical stage, we will develop this potential best-in-class treatment to serve the patients in China and beyond.”

“Congratulations to CANbridge on achieving this great company milestone of CAN106,” said Dr. Chris Chen, CEO of WuXi Biologics. “We are honored to enable innovative partners like CANbridge through WuXi Biologics’ integrated technology platform, and we wish the program great clinical success to benefit patients worldwide.”

About Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal nocturnal hemoglobinuria (PHN) belongs to a group of fatal and rare disorders that occur when the complement system, a part of the immune system, is dysregulated. In PNH, this results in the destruction of the red blood cells, which leads to severe anemia and, eventually, death. Treatment options are limited to allogenic bone marrow transplant and monoclonal antibody treatments, eculizumab and ravulizumab-cwvz. PHN is an acquired condition, so can occur at any age across gender and race, but females seem to get it at a slightly higher rate, as do people in their 30s and 40s. It continues throughout the life of the patient. The PNH incidence rate in Western countries is 1-2/1,000,000 per year. In Asia, the rate is approximately 10 per million per year, according to the 2019 China Rare Diseases Diagnosis and Treatment Guide.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers to address unmet medical needs.

CANbridge has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In greater China, where it is a recognized leader in orphan diseases, CANbridge 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 11 countries worldwide. CANbridge also has a collaborative agreement with the Horae Gene Therapy Center at UMass Medical School for the research and development of gene therapies to treat rare genetic diseases. The CANbridge oncology portfolio includes exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib), which was recently approved in greater China, as well as 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/20201218005168/en/

CONTACT

CANbridge Pharmaceuticals Inc.

ir@canbridgepharma.com

Media:

Deanne Eagle

Planet Communications

deanne@planetcommunications.nyc

917.837.5866

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