Hengrui Pharma’s new gout drug SHR4640 has been approved for marketing
On May 28, the NMPA website announced that Hengrui Pharma’s Class 1 new drug SHR4640 has been approved for marketing in patients with gout and hyperuricemia.
SHR4640 (R&D code: SHR4640; also known as Ruzinurad) is a highly selective small-molecule inhibitor of the urate transporter (URAT1). URAT1 is specifically expressed in renal tubular epithelial cells. By selectively inhibiting URAT1‑mediated urate transport, SHR4640 suppresses urate reabsorption, promotes urate excretion, and thereby reduces serum uric acid levels.
According to Insight Database, the drug first filed for clinical trial in March 2014 and submitted its first marketing application in January 2025. Notably, with this approval, SHR4640 becomes the first domestically developed URAT1 inhibitor approved for marketing in China.
This approval is based on a multicenter, randomized, double‑blind, active‑controlled Phase III study (SHR4640‑303; NCT04956432/CTR20211140). The corresponding clinical data were presented at the 2025 European Alliance of Associations for Rheumatology (EULAR) annual congress. Results show that compared with the active control allopurinol, SHR4640 significantly increases the proportion of gout patients achieving target serum uric acid (sUA) levels, with a favorable safety profile, offering a new treatment option for these patients.
Gout is a crystal‑related arthropathy caused by monosodium urate deposition. In addition to joint damage, it can be accompanied by kidney disease and other metabolic syndrome manifestations such as hyperlipidemia, hypertension, and diabetes. With changing lifestyles and dietary habits, gout has become the second most common metabolic disease after diabetes.Focusing solely on the URAT1 target, nearly 20 drugs in China have initiated clinical trials (excluding those only filed for or granted clinical trial approval), representing intense competition. Hengrui Pharma’s SHR4640 is at the forefront – it is the second URAT1 inhibitor approved in China and the first domestically developed one.
