" class="no-js "lang="en-US"> CANbridge given Approval of Alagille Syndrome Treatment in China
Tuesday, April 23, 2024

CANbridge Announces Marketing Approval of CAN108 in China for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome

CANbridge Pharmaceuticals, a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced that the Chinese National Medical Products Administration (NMPA) has approved CAN108 to be marketed for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

LIVMARLI is approved in the United States for the treatment of cholestatic pruritus in patient with ALGS in patients three months of age and older and is authorized in Europe for patients two months and older. LIVMARLI was approved for cholestatic pruritus last year under the Early and Pilot Implementation Policy in the Boao Lecheng International Medical Tourism Pilot Zone in China. CANbridge has an exclusive license with Mirum Pharmaceuticals, Inc. for the development, commercialization and manufacturing, under certain conditions, of LIVMARLI in Greater China for three rare liver disease indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA), as well as other select indications. LIVMARLI is currently being investigated in an ongoing Global Phase 2 study (EMBARK) for biliary atresia.

“We are delighted to have received marketing approval for LIVMARLI in mainland China so soon after this novel treatment was approved in the leading Western markets,” said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. “The fact that we will be able to offer Chinese rare disease patients the same advanced therapies available in other parts of the world both speaks to our regulatory expertise and our mission to make life-changing therapies accessible to patients worldwide. LIVMARLI is the only approved medication in China to treat cholestatic pruritus associated with ALGS. We look forward to bringing this promising new treatment to thousands of ALGS patients in China and to developing LIVMARLI for other indications. We would also like to thank our partner, Mirum.”

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