HENGRUI PHARMA announced that its wholly-owned subsidiary, Jiangsu Hengrui Pharmaceuticals Co., Ltd., has received notification from the National Medical Products Administration approving the marketing of its self-developed Class 1 innovative drug Luzinuolei Sodium Tablets (SHR4640 Tablets). This product represents China's first self-developed new-generation high-selectivity URAT1 inhibitor.

In China, the prevalence of hyperuricemia among adults is as high as 17.7%, affecting approximately 180 million people. The prevalence of gout is 3.2%, impacting around 36 million individuals. The primary pathological mechanism leading to hyperuricemia is a dynamic imbalance in the "urate pool," caused by either excessive uric acid production or insufficient excretion. Hyperuricemia is the most significant risk factor for the onset and progression of gout. Therefore, uric acid-lowering therapy is a core long-term management strategy for gout.

Currently, commonly used clinical xanthine oxidase (XO) inhibitors, such as febuxostat, act on the uric acid production pathway, aiming to reduce its synthesis. However, approximately two-thirds of the uric acid produced in the human body needs to be excreted via the kidneys. Even with reduced production, inadequate excretion can still prevent patients from reaching target serum uric acid levels. Studies indicate that 30% to 70% of patients treated with XO inhibitors alone fail to achieve their target serum uric acid levels.

Urate transporter 1 (URAT1) is responsible for about 90% of uric acid reabsorption in the kidneys, making it a core target for regulating uric acid excretion. Luzinuolei Sodium Tablets are a self-developed small molecule Class 1 new drug that highly selectively inhibits URAT1, thereby inhibiting uric acid reabsorption, promoting uric acid excretion, and lowering serum uric acid levels.

Currently, China has a large and growing population of gout patients, with an increasing trend among younger individuals, yet treatment options remain limited. Globally, the only highly selective URAT1 inhibitor for gout with hyperuricemia currently on the market is dotinurad tablets, which were approved in January 2020 and received marketing authorization in China in December 2024. According to inquiries, the global sales of dotinurad tablets in 2025 were approximately $39.34 million.

To date, the cumulative research and development investment for the Luzinuolei Sodium Tablets project is approximately 312.2 million yuan (unaudited).