28 February 2022 | News
Under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone
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CANbridge Pharmaceuticals, Inc. has announced that CAN108 (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 United States Food and Drug Administration (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 CAN108 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.
“Being able to offer this promising investigational treatment to Chinese patients soon after its US approval, is a realization of our core commitment to deliver complete patient solutions and part of why we founded the company,” said James Xue, Ph.D., CANbridge Founder, Chairman and CEO. “As the world takes note of another Rare Disease Day, we are pleased to be able to offer this specific kind of support to rare disease patients in China.”