China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for its SHR4640 as a long-term treatment for primary gout with hyperuricemia has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients suffering from this condition.
Drug Profile and Mechanism
SHR4640, a Category 1 drug, selectively inhibits the urate transporter protein (URAT1) associated with uric acid reabsorption in the kidneys. By suppressing uric acid reabsorption, SHR4640 reduces blood uric acid levels, making it a potential therapeutic option for primary gout and hyperuricemia.
Clinical Trial Results
The Phase III SHR4640-303 study found that compared with allopurinol, SHR4640 showed statistically significant and clinically superior improvement in primary gout with hyperuricemia. The study also demonstrated good safety and tolerability in patients with primary gout accompanied by hyperuricemia. This positions SHR4640 as a promising new treatment in the field.
Global Context
Globally, URAT1 inhibitors targeting gout and hyperuricemia include Eisai’s Urece (dotinurad). The acceptance of SHR4640 for review by the NMPA highlights the growing interest in developing more effective treatments for these conditions, potentially offering patients a new and improved therapeutic choice.
Significance of the Market Filing
The acceptance of SHR4640 for review by the NMPA is a crucial milestone for Hengrui Pharmaceuticals. It brings the company one step closer to bringing this innovative treatment to market, potentially improving the management of gout and hyperuricemia for patients in China and beyond.-Fineline Info & Tech
