中国食品药品监管Issue(7)：26-35,10.DOI:10.3969/j.issn.1673-5390.2024.07.003
非酒精性脂肪性肝炎新药研发的回顾与思考
Review and Reflection on the Development of New Drugs for Non-Alcoholic Steatohepatitis
尹茂山 1王寅 1李峥 1王士奇 1尹华静 1笪红远 1叶旋1
作者信息
摘要
Abstract
Non-alcoholic fatty liver disease(NAFLD)has become the most prevalent chronic liver disease in China.Among the various phenotypes of NAFLD,non-alcoholic steatohepatitis(NASH)is highly likely to develop into end-stage liver diseases,including cirrhosis and liver cancer,leading to increased mortality.This is also the main cause of liver transplantation in developed countries or region in Europe and America.At present,the treatment of NASH remains in the form of combination therapy,and there are serious unmet clinical needs for targeted new drugs.Apart from the approval of the new drug Resmetirom in the United States,no other NASH new drugs are on the market domestically or internationally.The medicinal properties and evaluation criteria of NASH new drugs have always been of significant concern.The lack of support for non-clinical pharmacodynamics research and the impact of clinical trials not meeting endpoint evaluation indicators on the druggability of new drugs are reflected in the development status of NASH new drugs.This also suggests that whether non clinical pharmacodynamics research results support the use of NASH clinical trials and whether clinical trials can achieve evaluation endpoints are key factors in promoting the development process of NASH new drugs.关键词
非酒精性脂肪性肝病/非酒精性脂肪性肝炎/有效性/成药性/回顾与思考Key words
non-alcoholic fatty liver disease/non-alcoholic steatohepatitis/efficacy/druggability/review and reflection分类
医药卫生引用本文复制引用
尹茂山,王寅,李峥,王士奇,尹华静,笪红远,叶旋..非酒精性脂肪性肝炎新药研发的回顾与思考[J].中国食品药品监管,2024,(7):26-35,10.
