By Fineline Cube Yipinhong Pharmacy Group Co., Ltd (SHE: 300723) announced that its Phase 3 trial for the Category 1 drug AR882 (Pozdeutinurad) in patients with gout and hyperuricemia has met its primary endpoint. In a 683-participant study, the AR882 75mg group achieved significantly superior serum uric acid (sUA) reduction versus febuxostat at 24 weeks — a pivotal validation for the next-generation URAT1 inhibitor that could redefine treatment standards in one of China’s most prevalent metabolic diseases.
Trial Overview
| Item | Detail |
|---|---|
| Sponsor | Yipinhong Pharmacy Group Co., Ltd (SHE: 300723) |
| Product | AR882 (Pozdeutinurad), Category 1 drug |
| Study Design | Phase 3, active-controlled |
| Comparator | Febuxostat 40mg |
| Population | Patients with gout and hyperuricemia |
| Enrollment | 683 participants |
| Primary Endpoint | Met (P<0.001) |
| Date | 03 Sept 2026 |
Clinical Evidence – Phase 3 Results
| Endpoint | AR882 75mg (24 Weeks) | Statistical Significance |
|---|---|---|
| Primary: sUA <360 μmol/L | 86.0% | Superior to febuxostat 40mg (P<0.001) |
| Key secondary: sUA <300 μmol/L | 71.3% | Superior to febuxostat (P<0.001) |
| Key secondary: sUA <240 μmol/L | 50.3% | Superior to febuxostat (P<0.001) |
The Phase 3 results demonstrate that AR882 75mg not only met its prespecified primary efficacy endpoint with statistically significant superiority over the active comparator, but also delivered robust responses at the more stringent secondary thresholds of sUA <300 μmol/L and <240 μmol/L — levels associated with crystal dissolution and long-term disease control. Importantly, AR882 demonstrated a favorable safety and tolerability profile, a critical factor for a chronic urate-lowering therapy.
Drug Profile & Mechanism of Action
- Molecule: AR882 (Pozdeutinurad), a next-generation, highly selective uric acid transporter 1 (URAT1) inhibitor
- Mechanism: Reduces serum uric acid by inhibiting uric acid reabsorption and promoting urate excretion in urine
- Duration: Designed for long-lasting target binding, with clinical results showing a 24-hour duration of action supporting once-daily dosing
- Commercial Rights: Yipinhong holds all commercialization rights to AR882 in Greater China (mainland China, Hong Kong, Macau, and Taiwan)
- Global Role: Yipinhong holds the priority right for global manufacturing and supply of AR882 for its U.S.-based associate company, Arthrosi Therapeutics Inc.
Market Impact & Outlook
- Best-in-class potential: Superiority over febuxostat — a leading urate-lowering therapy — across all tested sUA thresholds positions AR882 as a potential best-in-class URAT1 inhibitor
- Large addressable market: Gout and hyperuricemia affect a substantial and growing patient population in China, where current therapies face efficacy ceilings and safety concerns
- Deep-response advantage: Achieving sUA <240 μmol/L in half of patients addresses the severe, tophaceous gout population with particularly high unmet need
- Global upside: The partnership structure with Arthrosi Therapeutics provides Yipinhong exposure to worldwide development and supply economics beyond its Greater China franchise
- Portfolio momentum: The Phase 3 readout strengthens Yipinhong’s (SHE: 300723) transition from a pharmaceutical distributor toward an innovation-driven specialty pharmaceutical company
Forward‑Looking Statements: This brief is for informational purposes only and does not constitute investment advice or an offer to buy or sell any security. Statements regarding drug development, regulatory submissions and commercial potential are forward-looking and subject to risks and uncertainties, including regulatory decisions, competitive developments and market adoption. Actual results may differ materially. Readers should conduct their own due diligence before making investment decisions.-Fineline Info & Tech