Approval of CAN 108 for rare liver disease, Alagille syndrome, under the early and pilot implementation policy in Boao Lecheng International Medical Tourism Pilot Zone, China.
CANbridge Pharmaceuticals, Inc a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, announced that CAN 108 (maralixibat), a treatment for Alagille syndrome (ALGS), has been approved under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone, which will allow it to be imported and used as an urgently needed drug in the region.
Maralixibat was approved by the FDA in September 2021 for the treatment of cholestatic pruritus in patients aged one year and older with ALGS. There are no approved drugs for the disease in China, where there is a large unmet need for treatment. The “Early and Pilot Implementation” Policy of Boao Lecheng International Medical Tourism Pilot Zone enables Chinese patients to access therapeutics that are available in other parts of the world, thereby improving the quality of life of patients, especially children.
CANbridge has the exclusive license to develop and commercialize CAN 108 in Greater China for three rare liver disease indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA). The National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for CAN108 for Alagille syndrome in China under priority review.
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