▎WuXi AppTec Content Team Report

January 22,EisaiAnnouncementDutinore TabletsNew DrugThe listing application has been approved.National Medical Products Administration of ChinaMedicineCenter for Drug Evaluation (CDE)Accepted.Dotinurad Tablets (dotinurad)) is a uricosuric agent, which was previously approved in Japan in 2020 for the treatment ofHyperuricemia and Gout。

Screenshot source:CDE Official Website

Gout is a crystal-associated arthropathy caused by the deposition of monosodium urate in joints. The prevalence rate in China is currently 1% to 3% and shows an increasing trend year by year. In addition to causing severe pain during acute attacks and damaging joints, gout can also be accompanied by kidney lesions and other manifestations of metabolic syndrome, such as hyperlipidemia, hypertension, diabetes, and coronary heart disease. Excessively high blood uric acid levels (i.e., hyperuricemia) are a significant risk factor for the development of gout.

According to the Eisai press release, Dotinurad is a novel gout treatment drug,By selectively inhibiting the urate transporter 1 (URAT1) associated with uric acid reabsorption in the kidneys, uric acid reabsorption is suppressed and serum uric acid levels are reduced.. As a URAT1 selective inhibitor, this product effectively inhibits URAT1 in the renal proximal tubules without affecting the function of uric acid excretion factors ABCG2 and OAT1/3. Compared with non-selective URAT1 inhibitors, it is more efficient in lowering blood uric acid. Public data shows,Dutinore was initially developed byFujiMedicine (FUJI YAKUHIN）Research and Development,EisaiIn 2020Entered into a licensing agreement with Fuji Pharmaceuticals to obtain the exclusive development and sales rights for this product in China.

Previously, the results of a Phase 3 clinical study conducted in Japan showed that dotoserol4mg treats patients with hyperuricemia with or without gout,The proportion of patients with blood uric acid levels ≤6mg at 58 weeks was 100%., Long-term use has no significant impact on renal function and no clinically relevant impact on liver function.。In China,EisaiLaunched aAim to Evaluate the Efficacy of Doteinore and Febuxostat in the Treatment of GoutPhase 3 Clinical Study。The study enrolled 451 patients with gout.Patients were randomly divided into Dutinore4mg Group and Febuxostat40mg group, the primary endpoint is the serum uric acid level ≤ after 24 weeks of treatmentPercentage of Patients with 6.0 mg/dL。