Suzhou, China - CANbridge Pharmaceuticals Inc. ('CANbridge', stock code: 1228.HK), a global biopharmaceutical company focused on rare diseases, is committed to the research, development and commercialization of innovative therapies.
The Company today announced that Livmarli (maralixibat chloride oral solution), indicated for the treatment of Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC), has obtained reimbursement approval from National Health Insurance Administration (NHIA) in Taiwan. The reimbursement coverage will take effect on September 1, 2026.
James Xue, Ph.D., Founder, Chairman and CEO of CANbridge, said: 'Patients living with rare diseases have long struggled with high medication costs. As the first approved therapy for ALGS and PFIC in Taiwan, Livmarli gaining NHIA reimbursement approval for both indications marks a significant milestone for patients living with ALGS and PFIC. This development will immediately and substantially alleviate the financial burden on patient families in Taiwan. We look forward to continuously working with the Taiwan NHIA and the Taiwanese cholestatic pruritus community to allow all eligible patients to gain early access to Livmarli toward achieving optimal improvements in quality of life.'
About Livmarli (Maralixibat Chloride Oral Solution /???)
Livmarli (Maralixibat Chloride Oral Solution /???) 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 resultant liver injury and relieves pruritus (extreme itching). Livmarli is the first medication approved in Mainland China, Hong Kong and the U.S. to treat ALGS in patients 3 months of age and older, and the first medication approved for this indication in the EU and Taiwan in patients 2 months of age and older. It is also approved in the U.S. for the treatment of PFIC in patients 12 months of age and older and in the EU, Hong Kong and Taiwan for the treatment of PFIC in patients 3 months of age and older.
Livmarli has been granted Breakthrough Therapy designation for ALGS and PFIC and orphan designation for ALGS and PFIC by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Taiwan Food and Drug Administration (TFDA).
About ALGS
Alagille syndrome (ALGS) is an autosomal dominant multisystem disorder that can lead to end-stage liver disease and death. Its incidence is between 1/30,000 and 1/50,000. It has been registered in National Rare Diseases Registry System of China (NRDRS). ALGS is characterized by intrahepatic bile duct paucity, together with involvement of extrahepatic organs including the kidneys, eyes, skeleton and cardiovascular system.. 100% of patients experience liver involvement, which often manifests as chronic cholestasis (slowed or stalled bile flow), usually in the neonatal period or within the first 3 months after birth. In addition to jaundice, skin xanthoma and hepatomegaly, patients will also experience severe pruritus, which can lead to skin disfigurement, emotional disorder, sleep deprivation and interruption of school learning, due to scratching in affected children. It seriously affects the growth, development and quality of life of patients and can lead to liver transplantation.
About PFIC
Progressive Familial Intrahepatic Cholestasis (PFIC) represents a group of rare genetic disorders caused by deficiencies in specific proteins involved in hepatocellular transport systems and bile formation. The condition manifests as intrahepatic cholestasis, triggering progressive liver disease that may ultimately advance to end-stage liver disease. Approximately 70% to 80% of patients will eventually require liver transplantation. Signs and symptoms of PFIC typically begin in infancy. Patients experience severe itching, jaundice, failure to grow at the expected rate (failure to thrive), and an increasing inability of the liver to function (liver failure). The disease is estimated to affect one in every 50,000 to 100,000 births in the United States and Europe. 13 types of PFIC have been genetically identified, all of which are similarly characterized by impaired bile flow and progressive liver disease.
About CANbridge
CANbridge Pharmaceuticals Inc. (Stock Code: 1228.HK) was founded in 2012 and listed on the Main Board of HKEX in 2021. The Company is a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases.
As of December 31, 2025, the Company has a comprehensive pipeline of 7 drug assets targeting prevalent rare diseases that have high unmet needs and significant market potential. The robust pipeline includes 3 marketed products (Hunterase, Livmarli, Gaurunning) and 1 drug candidate at the late clinical stage, covering biologics, small molecules and gene therapies. In the rare disease area, the Company currently has seven biologic and small molecule product candidates. These include MPS II (Hunter syndrome) and other lysosomal storage disorders (LSDs), complement-mediated disorders, hemophilia A, metabolic disorders and rare cholestatic liver diseases including Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Furthermore, CANbridge is investing in the R&D of next-generation gene therapy technologies, which will provide novel, potentially curative therapies for rare genetic diseases with limited treatment options. To support the research, development and commercialization of its pipeline, the Company has built a global partner network including, but not limited to, WuXi AppTec, WuXi Biologics, Baheal Medical, GC Pharma, Mirum, Privus and Scriptr Global.
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