China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative gout drug SHR4640. The study will evaluate the drug in combination with febuxostat for hyperuricemia in gout patients.
Drug Mechanism
SHR4640 is a urate transporter 1 (URAT1) inhibitor designed to selectively block URAT1 on renal tubular epithelial cells, reducing uric acid reabsorption and lowering serum uric acid levels. This mechanism targets the underlying cause of hyperuricemia in gout patients.
Clinical Trial Design
The trial will compare SHR4640 directly against AstraZeneca’s Zurampic (lesinurad), a urate transporter inhibitor approved by the US FDA in December 2015. Lesinurad, and its fixed-dose combination with allopurinol (Duzallo), have not yet gained approval in China. This head-to-head study aims to demonstrate SHR4640’s efficacy and safety profile in gout patients who have not achieved target serum uric acid levels with existing therapies.-Fineline Info & Tech
