Febuxostat

9 月 8 日，新元素药业宣布，其 ABP-671 用于治疗痛风的全球 IIb/III 期临床试验取得了十分积极的结果。 截图来源：企业官网 这是一项多中心、随机、双盲、别嘌醇阳性（Treat-to-Target）和安慰剂对照的全球性研究，在包括美国、欧洲、澳洲、拉丁美洲、台湾等多个国家和地区开展，以 6 个月为主要终点评估周期。 结果显示，该项临床试验达到所有主要治疗终点及次要治疗终点。在与阳性对照组别嘌醇，即别嘌醇每天最高治疗剂量可达 800 mg，以达到血尿酸水平< 6 mg/dL（360 μmol/L）的比较中，ABP-671 展现出优异的降尿酸作用，特别是受试者在血尿酸水平< 5 mg/dL（300 μmol/L）以及< 4 mg/dL（240 μmol/L）有更高及优异的达标率。 同时，相较于别嘌醇组和安慰剂组，ABP-671 在统计的 15-28 周内，可显著地降低急性痛风发作的频率，风险降低率达 42%。在为期仅 6 个月的治疗中，ABP-671 展现出对溶解痛风石的良好药效，受试者痛风石直径较基线出现显著减小；基线与第 28 周之间的痛风石直径减小的反应率达到 91%。 同时，ABP-671 展现出良好的安全性和耐受性，推荐的 3 期临床剂量组的总体不良反应事件发生率与安慰剂组相当。相较于其它降尿酸药物，如非布司他、苯溴马隆及一些在研药物出现的心血管风险及/或肝脏毒性，ABP-671 临床试验未见心血管风险，肝毒性等。 新元素药业 CEO 史东方博士表示，一系列的积极的临床数据证明 ABP-671 具有良好的药效、安全性和耐受性，有望成为痛风领域新一代 Best-in-Class 的治疗药物。 未来，ABP-671 计划进一步与别嘌醇做对照，来完成下阶段关键性临床试验，旨在成为欧美痛风首选一线用药。 目前，别嘌醇为欧美治疗痛风的一线用药，约占痛风用药处方的 90%。但常规剂量 300 mg 下疗效有限，只有大约 40% 痛风病人血尿酸水平达到< 6 mg/dL，而达到血尿酸水平< 5 mg/dL 更优治疗目标的患者比例更是不到 20%，且当别嘌醇剂量大于 300 mg 时会有很多患者不耐受。  ABP-671 良好的药效和安全性将改变目前痛风治疗格局。此外，在别嘌醇的标签中，也限制了中度至重度肝损伤患者的使用，这也将限制大量有非酒精性脂肪肝（NAFLD）等肝损伤的痛风患者的使用。ABP-671 良好的肝脏安全性将支持在此类临床需求未得到满足的人群中无限制使用。 拓展阅读： 下一个百亿蓝海赛道，开始爆发 封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

SAN FRANCISCO and SUZHOU, China, Sept. 7, 2025 /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, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced that the results of the Phase 2 clinical study of the xanthine oxidase inhibitor (XOI) tigulixostat (R&D code: IBI128) in Chinese gout participants were presented at the 2025 Asia-Pacific League of Associations for Rheumatology (APLAR) Congress. Tigulixostat demonstrated significantly greater urate-lowering efficacy and favorable safety profiles compared to febuxostat across all dose groups. Based on these positive data, Innovent plans to initiate the Phase 3 clinical study of tigulixostat in China in the second half of 2025. Continue Reading * P＜0.05,** P＜0.01, *** P＜0.001 The published results are based on a randomized, open-label, multicenter, parallel-group, active-controlled Phase 2 clinical study (NCT06501534) evaluating the efficacy and safety of different doses of tigulixostat in Chinese gout participants. A total of 84 participants (mean age: 37 years; mean baseline serum uric acid [sUA]: 575 μmol/L [9.6 mg/dL]; mean baseline weight: 80.7 kg) were enrolled and randomized to receive tigulixostat 50 mg, 100 mg, 200 mg or febuxostat 40 mg for 16 weeks (or 18 weeks for the tigulixostat 200 mg group). The primary endpoint was the proportion of participants achieving sUA <360 μmol/L (6 mg/dL) at Week 16. Tigulixostat demonstrated significantly greater urate-lowering efficacy compared to febuxostat across all dose groups, with a dose-dependent effect. At week 16, 55.0% of participants in the tigulixostat 50 mg group, 81.0% in the tigulixostat 100 mg group, and 85.7% in the tigulixostat 200 mg group, achieved sUA <360 μmol/L (6 mg/dL), respectively, compared with 18.2% in the febuxostat 40 mg group, the treatment difference versus febuxostat was 36.8% (95%CI: 9.7, 63.9, P<0.01), 62.8% (39.5, 86.0, P<0.001), and 67.5% (45.5, 89.5, P<0.001) for the tigulixostat 50 mg group, 100 mg group, and 200 mg group, respectively; At week 16, 30.0% of participants in the tigulixostat 50 mg group, 61.9% in the tigulixostat 100 mg group, and 81.0% in the tigulixostat 200 mg group, achieved sUA <300 μmol/L (5 mg/dL), respectively, compared with 9.1% in the febuxostat 40 mg group, the treatment difference versus febuxostat was 20.9% (95%CI: –2.5, 44.3, P<0.05), 52.8% (28.8, 76.8, P<0.001), and 71.9% (51.2, 92.5, P<0.001) for the tigulixostat 50 mg group, 100 mg group, and 200 mg group, respectively. At week 16, the percent change in sUA from baseline were -38.66% in the tigulixostat 50 mg group, -48.61% in the tigulixostat 100 mg group、-57.11% in the tigulixostat 200 mg group, and -24.11%（in the febuxostat 40 mg group. Tigulixostat demonstrated a favorable safety profile, no increased risk of renal impairment. The incidence of adverse events was similar across groups. All reported AEs were mild to moderate in severity. No serious adverse events or adverse events of special interest were observed in any tigulixostat -treated groups. No adverse events led to temporary or permanent discontinuation of the study drug was observed. Without any gout flare prophylaxis during the study, the incidences of gout flare were comparable between the tigulixostat total group and the febuxostat 40 mg group. Most gout flare occurred during the initial 4 weeks of treatment, with the incidence gradually decreasing and reaching a plateau subsequently. It has been reported that higher and more sustained serum uric acid target achievement can significantly reduce the risk of gout flare[1]. The Principal Investigator of the Study, Professor Hejian Zou from Huashan Hospital affiliated with Fudan University, stated: "Gout and hyperuricemia are increasingly becoming the 'fourth major' chronic disease following hypertension, hyperlipidemia, and hyperglycemia. The overall prevalence of hyperuricemia in China is 13.3%, and hyperuricemia is a prerequisite for gout. Among hyperuricemia patients, approximately 15.5 million suffer from gout. Gout patients face an increased risk of cardiovascular diseases and chronic kidney diseases, and it is also closely associated with comorbidities such as diabetes and stroke, often leading to significantly elevated mortality risks. Currently, commonly used clinical drugs for gout in China face safety concerns, including potential cardiovascular risks and hepatorenal toxicity, highlighting the urgent need for safer and more effective treatment options. Tigulixostat is a novel non-selective XO inhibitor, and the Phase 2 clinical study results in Chinese gout participants have fully demonstrated its significantly urate-lowering efficacy with a good safety profile. I am delighted to see these results presented at an international academic conference and look forward to that tigulixostat entering registered clinical development soon, in hopes that this development can lead to new treatment options for gout patients in China." Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent Biologics, stated, "We are delighted to present the Phase 2 clinical study results of tigulixostat at the international academic congress. The study demonstrated tigulixostat's superior urate-lowering efficacy compared to febuxostat, while maintaining a favorable safety profile across multiple dose levels in Chinese gout participants. Building on these findings and through ongoing communication with regulatory authorities, we will accelerate the Phase 3 clinical development of tigulixostat to bring this promising treatment option to Chinese gout patients as soon as possible. As part of our commitment, Innovent Biologics will continue to advance our next-generation pipeline in cardiovascular and metabolic diseases, targeting the broad population affected by hypertension, hyperlipidemia, hyperglycemia, and hyperuricemia. We remain dedicated to fulfilling patients' aspirations for healthier lives and expanding access to innovative therapies." About Gout Gout is an inflammatory arthritis caused by the gradual elevation of uric acid levels in the blood, exceeding its solubility threshold[2], leading to the deposition of monosodium urate (MSU) crystals in joints. Persistent hyperuricemia can result in the accumulation of urate crystals (tophi) in joints, tendons, and other tissues, which, under triggering factors (e.g., trauma, cold exposure, inflammatory stimuli), may provoke acute inflammatory episodes known as acute gout attacks. Hyperuricemia is a metabolic disorder syndrome resulting from purine metabolism dysfunction. It is defined as serum uric acid levels exceeding 420 μmol/L on two separate occasions, regardless of gender. Hyperuricemia and gout represent a continuous, chronic pathophysiological spectrum and constitute a systemic disease affecting multiple organ systems. The prevalence of hyperuricemia varies across ethnicities, ranging from 2.6% to 36%, while gout prevalence ranges from 0.03% to 15.3% globally[3]. The most widely prescribed urate-lowering drugs in China are xanthine oxidase (XO) inhibitors: allopurinol and febuxostat. However, allopurinol carries a significant risk of hypersensitivity syndrome in Han Chinese populations, with associated mortality reaching approximately 30%. This safety concern has substantially restricted its clinical utility. Meanwhile, long-term febuxostat use demonstrates associations with elevated risks of hepatic dysfunction and cardiovascular adverse events[4-7]. These limitations underscore the urgent need for novel therapeutic agents with improved safety profiles and enhanced efficacy in hyperuricemia management. About Tigulixostat (IBI128) Tigulixostat (IBI128) is a next-generation, non-purine selective xanthine oxidase inhibitor (XOI). It exerts its therapeutic effect by inhibiting xanthine oxidase activity, thereby blocking the conversion of hypoxanthine and xanthine to uric acid. This mechanism reduces uric acid production and subsequently lowers serum uric acid levels, making it an effective treatment for hyperuricemia in gout patients. Currently, tigulixostat has completed a Phase 2 clinical study in the United States, an international multicenter Phase 3 clinical study, and Phase 1 and Phase 2 clinical studies in China. The collective data demonstrate that tigulixostat significantly reduces serum uric acid levels and improves urate-lowering target achievement rates in a dose-dependent manner, with superior efficacy compared to febuxostat. Tigulixostat exhibited favorable tolerability across all dose groups, with no observed dose-dependent adverse events. In December 2022, Innovent Biologics entered a strategic collaboration with LG Chem, securing exclusive development and commercialization rights for tigulixostat in China. About Innovent 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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED