SAN FRANCISCO and SUZHOU, China, March 22, 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. "
About Tigulixostat (IBI128)
IBI128 (tigulixostat) is a novel non-purine selective xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout.[1] Preclinical studies have confirmed its unique mechanism of action, while early clinical trials (including Phase 1 and Phase 2) have shown significant urate-lowering efficacy and good safety, and the Phase 2 results have actively promoted the initiation of Phase 3 studies.Â
In December 2022, Innovent Biologics entered a strategic collaboration with LG Chem, in-licensing exclusive development and commercialization rights for tigulixostat in China.
About Gout
The prevalence of gout is increasing rapidly worldwide and in China, with prominent characteristics of younger age. According to the latest research, the overall prevalence of hyperuricemia in China is 17.7%, and the prevalence of gout is 3.2%. The patient base is large, with approximately 177 million people in hyperuricemia, including more than tens of millions of patients with gout.[4] The young population has become a high-incidence population: nearly 60% of the patients are between the ages of 18 and 35 years, and the average age of onset has decreased to 48.28 years, which is closely related to high-purine diet, intake of sugar-containing beverages, and sedentary lifestyle. The harm of gout far exceeds that of joint pain, and it has been identified as a systemic disease. Long-term uncontrolled gout can lead to irreversible organ damage and serious complications, including joint and motor function damage, kidney and metabolic system risks, socioeconomic burden, etc.[1,2,4], which may lead to a decline in the quality of life of patients, as well as negative effects such as labor loss.
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent Biologics does not recommend the use of unapproved drugs/indications.Â
Forward-Looking Statement
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
References
Chinese Society of Endocrinology, Chinese Medical Association. 2019 Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout. Chinese Journal of Endocrinology and Metabolism, 2020, 36(01): 1-13.
Martillo MA, Nazzal L, Crittenden DB. (2014). The crystallization of monosodium urate. Current Rheumatol Rep.16(2):400.
Lisa K Stamp et al., (2021). Association between serum urate and flares in peoplewith gout and evidence for surrogate status: a secondary analysis of tworandomised controlled trials. The Lancet Rheumatology. DOI: https://doi.org/10.1016/S2665-9913(21)00319-2.
Front lmmunol.2022 Feb 712:791983.eCollection 2021
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