Innovent begins phase 3 dosing of gout treatment candidate

SAN FRANCISCO and SUZHOU, China, March 23, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the xanthine oxidase inhibitor (XOI) Tigulixostat(R&D code: IBI128) have the first participant dosed in a Phase 3 clinical study in head-to-head comparison of febuxostat, aiming to provide a better treatment option for Chinese gout patients. In a previous Phase 2 clinical study, tigulixostat showed a more significant urate-lowering effect and a good safety profile compared with the febuxostat group. The Phase 2 clinical data were published at the Asia-Pacific League of Associations for Rheumatology (APLAR) conference in 2025.

This study adopts a randomized, double-blind, multi-center Phase 3 design, and plans to enroll 600 Chinese patients who meet the 2015 ACR/EULAR gout diagnostic criteria, and randomize them in a 1:1 ratio to receive tigulixostat 100 mg or febuxostat 40 mg for 24 weeks. The treatment period of the trial was one year. The primary endpoint was the proportion of patients with serum uric acid (sUA) < 360 μmol/L at week 24.

The Principal Investigator of the Study, Professor Zou Hejian from Huashan Hospital, Fudan University, said: "Current gout treatment has dual challenges of drug safety concerns and insufficient efficacy. The Phase 2 data of IBI128 have shown significant advantages in lowering uric acid. This Phase 3 study, through head-to-head design and long-term observation, is expected to provide high-level evidence-based evidence for clinical practice. As a metabolic disease with the fastest growth rate in prevalence in China, gout also has multiple unmet medical needs, including the safety risks of existing drugs, such as cardiovascular risks, hypersensitivity reactions limiting clinical application, and the risk of acute kidney injury caused by excessive uric acid excretion load; the lack of efficacy, such as insufficient drug compliance rate and medication restrictions for patients with renal impairment. Tigulixostat is expected to provide a new treatment option to better meet the above needs. As a new-generation highly selective XOI, the 100 mg dose group in the Phase 2 study (CIBI128A201) had a sUA compliance rate (< 360 μmol/L) of 81% at 16 weeks, which was significantly better than that in the febuxostat 40 mg group. In addition, it showed good safety characteristics in previous clinical studies, with good renal and cardiovascular safety. This Phase 3 study will further verify its long-term therapeutic benefits and fill the unmet medical needs. "

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics, stated, "Gout is one of the largest chronic diseases in China, which has long brought a sustained health burden to millions of patients. However, compared with chronic diseases such as diabetes and hypertension, the current therapeutic options are still relatively limited. Gout patients urgently need innovative drugs that have potent uric acid-lowering effects and good safety, and the development of IBI128 reflects Innovent Biologics' proactive response, as an innovation-driven biopharmaceutical company, to address this significant unmet medical need. At the same time, Innovent has established a systematic pipeline strategy in the field of gout and hyperuricemia. In addition to IBI128, the company is advancing multiple innovative programs, including IBI3011, an IL-1RAP monoclonal antibody designed to control acute gout flares, as well as mazdutide, a globally innovative GCG/GLP-1 dual receptor agonist that may provide therapeutic benefits for patients with obesity complicated by hyperuricemia. By building a product portfolio covering different disease stages and patient needs, Innovent Biologics is expected to significantly enhance its comprehensive competitiveness in this therapeutic field and provide patients with a more comprehensive and personalized treatment option. "