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Primary biliary cholangitis (PBC) is a chronic progressive autoimmune cholestasis, which eventually leads to liver fibrosis and cirrhosis, but the pathogenesis is not totally clear. With the further under standing of the disease and the higher level of clinical diagnosis, the prevalence of PBC in China is on the rise. At present, only ursodeoxycholic acids and obeticholic acid are officially approved for the treatment of PBC around the world, therefore there are limited treatment options and unmet clinical needs. Several drugs with different targets are under development in China and abroad. This paper briefly summarizes the clinical development experiences of the drugs, in order to provide reference for research and evaluation.

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原发性胆汁性胆管炎（primary biliary cholangitis, PBC）是一种慢性进展性自身免疫性胆汁淤积性疾病，最终可导致肝纤维化及肝硬化，发病机制尚不完全明确。随着对疾病的认识及临床诊断水平的提高，我国PBC患病率呈上升趋势。目前，国际上被正式批准用于PBC的治疗药物仅有熊去氧胆酸和奥贝胆酸，治疗选择有限，存在未满足的临床需求。国内外有多个不同靶点的药物正在研发，通过干预胆汁酸形成、分泌、排泄等步骤，拟为PBC治疗提供新的药物选择。本文简要概述PBC治疗领域已批准药物的临床研发经验和在研药物的临床进展，以期为该类药物临床研发和评价提供参考。

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林琳，女，助理研究员，主要从事药品技术审评工作。E-mail: linl@cde.org.cn。

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林琳，女，助理研究员，主要从事药品技术审评工作。E-mail: linl@cde.org.cn。

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