CANBRIDGE-B (01228.HK): Maralixibat Oral Solution Approved for NHI Reimbursement in Taiwan, China, Effective 1 September
NewTimeSpace News: On 18 August 2026, CANbridge Pharmaceuticals Inc. (stock code: 01228) voluntarily announced that maralixibat oral solution, indicated for the treatment of Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), has been approved by the National Health Insurance Administration of Taiwan, China for inclusion in National Health Insurance (NHI) coverage, effective 1 September 2026.
Maralixibat is a minimally absorbed ileal bile acid transporter inhibitor that blocks the enterohepatic circulation of bile acids, reduces bile acid levels in the liver and serum, mitigates bile acid-mediated liver injury, and relieves cholestatic pruritus. The drug is the first approved treatment for cholestatic pruritus in ALGS patients aged 3 months and older in mainland China, Hong Kong, China and the United States, and the first drug approved for ALGS patients aged 2 months and older in the EU and Taiwan, China. For PFIC, maralixibat is approved in the US for patients aged 12 months and older, while the approved population in the EU, Hong Kong, China and Taiwan, China is 3 months and older.
The announcement further disclosed that maralixibat has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for both ALGS and PFIC, and has obtained orphan drug designation for ALGS and PFIC from the FDA, the European Medicines Agency and the Taiwan Food and Drug Administration.
The company considers maralixibat the first approved therapeutic for ALGS and PFIC in Taiwan, China, and believes the simultaneous inclusion of both indications in NHI coverage will substantially ease the long-term financial burden on patient families in the region, marking an important milestone in its rare disease commercialization strategy. The company looks forward to working with the NHI Administration and the cholestatic liver disease community to enable earlier treatment access for patients.
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