CANbridge Pharmaceuticals Inc. announced that the Chinese National Medical Products Administration (NMPA) has approved CAN108 (Maralixibat Chloride Oral Solution/Mai Rui Bei /LIVMARLI) 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. LIVMAR LI was approved for cholestatic prurus 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. CANbridge will hold investor calls to discuss the approval.

These will be on June 6, at 10:00 AM EDT, for the English-language call. LIVMARLI (CAN108 (maralixibat)) is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor that blocks the enterohepatic circulation of bile acids, reduces bile acid levels in the liver and serum, reduces the result of liver injury and relieves pruritus (extreme itching). LIVMARLI is the first, and only medication approved in China, the US and EU to treat cholestatic pruritis associated with Alagille syndrome (alGS).

In addition to ALGS, LIVMARLI is under clinical development by CANbridge for the treatment of other cholestatic liver diseases, including progressive familial intrahepatic Cholestasis (PFIC). and biliary atresia, and has been granted Orphan Drug designation by the FDA. CANbridge acquired the exclusive right to develop, commercialize and manufacture, under certain conditions, LIVMARLI in Greater China from Mirum Pharmaceuticals Inc. for ALGS, PFIC and BA, and select other indications.

LIVMARLI has been approved for marketing by China's National Medical Products Administration (NMPA) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) I year of age and older.