Hengrui：SHR4640 approved for marketing in China.
SHR4640, a Category 1 new drug independently developed, is the first domestically approved URAT1 selective inhibitor in China. It is indicated for the treatment of gout with hyperuricemia.
URAT1 is a urate transporter specifically expressed in renal tubular epithelial cells, responsible for approximately 90% of urate reabsorption in the kidney. SHR4640 selectively inhibit URAT1 activity, blocking urate reabsorption and accelerating urate excretion, directly targeting the core pathogenesis of hyperuricemia.
In August 2024, the Phase III clinical trial (SHR4640-303) of SHR4640 in subjects with primary gout and hyperuricemia was completed. Results showed that compared with the control drug, the drug significantly improved serum uric acid levels, with differences that were both statistically and clinically significant, and demonstrated a favorable safety and tolerability profile. According to available data, the domestic terminal hospital market size for anti-gout drugs exceeded RMB 1.5 billion in 2025, indicating strong clinical demand.
The drug’s marketing application was submitted and accepted in January 2025, and it was officially approved on May 28, 2026, for the treatment of patients with gout and hyperuricemia, making it the first approved domestically developed URAT1 inhibitor in China.
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