On September 8, 2025, according to information from Hangzhou, Zhejiang, and the United States, Xinyuan Pharmaceutical announced very positive results from the global Phase IIb/III clinical trial of ABP-671 for the treatment of gout. This study was a multicenter, randomized, double-blind, allopurinol-positive (Treat-to-Target) and placebo-controlled global study conducted across multiple countries and regions, including the United States, Europe, Australia, Latin America, and Taiwan, with a 6-month primary endpoint evaluation period.

The results showed that this clinical trial met all primary and secondary treatment endpoints. Compared to the active control group of allopurinol "Treat-to-Target" (where allopurinol could reach a maximum daily therapeutic dose of up to 800 mg to achieve a serum uric acid level of < 6 mg/dL [360 μmol/L]), ABP-671 demonstrated superior urate-lowering effects, particularly achieving higher and excellent target rates for subjects at serum uric acid levels of < 5 mg/dL (300 μmol/L) and < 4 mg/dL (240 μmol/L). Furthermore, compared to the allopurinol group and the placebo group, ABP-671 significantly reduced the frequency of "acute gout flares" during weeks 15-28, with a risk reduction rate of 42%. During the treatment period of only 6 months, ABP-671 showed a favorable effect on "dissolving tophi," with a significant reduction in tophi diameter from baseline for subjects; the response rate for "reduction in tophi diameter" between baseline and week 28 was 91%.

Concurrently, ABP-671 demonstrated a favorable safety and tolerability profile. The overall incidence of adverse events in the recommended Phase 3 dose group was comparable to that of the placebo group. Compared to other urate-lowering drugs such as febuxostat or benzbromarone, which have associated cardiovascular risks and/or liver toxicity, the ABP-671 clinical trial observed no cardiovascular risks or hepatotoxicity, among others.

ABP-671 is planned to be further compared against allopurinol in the next phase of pivotal clinical trials, aiming to become the preferred first-line medication for gout in Europe and the United States. Currently, allopurinol is the first-line treatment for gout in Europe and the US, accounting for approximately 90% of gout prescriptions. However, the conventional dose of 300 mg has limited efficacy, with only about 40% of gout patients achieving a serum uric acid level of < 6 mg/dL, and less than 20% achieving the more optimal treatment target of < 5 mg/dL. Furthermore, many patients cannot tolerate allopurinol at doses greater than 300 mg. The favorable efficacy and safety profile of ABP-671 have the potential to change the current gout treatment landscape. Additionally, allopurinol's labeling restricts its use in patients with moderate to severe hepatic impairment, which would also limit its use for a significant number of gout patients with liver injury, such as those with non-alcoholic fatty liver disease (NAFLD). ABP-671's favorable liver safety profile would support its unrestricted use in this population with unmet clinical needs.