Tafolecimab

SAN FRANCISCO and SUZHOU, China, June 27, 2024 /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, provided interpretation and updates on clinical data from Mazdutide's GLORY-1 study and its general biomedicine pipeline at an investor conference call on June 25. Continue Reading At the 2024 American Diabetes Association (ADA) Scientific Meeting, the company reported the results of its first Phase 3 clinical study (GLORY-1) on the GLP-1R/GCGR dual agonist mazdutide (Innovent R&D code: IBI362) in overweight or obese adults in China, along with the exploratory analysis results on liver fat content. During the June 25 conference call, leadership offered an in-depth interpretation of the clinical data. Innovent's Chief Financial Officer Rachel You and General Biomedicine Vice President of Clinical Development Lei Qian attended the meeting and made reports. Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, also provided commentary. GLORY-1 is the first Phase 3 clinical study worldwide evaluating a GLP-1R/GCGR dual agonist for weight loss. The findings demonstrate significant weight reduction, robust safety, unique liver fat reduction and comprehensive improvement in metabolic indicators, confirming the distinctive advantages of mazdutide as a dual agonist targeting GLP-1R and GCGR. At the same time, Innovent is actively pursuing new development pathways, including innovative molecules that extend beyond T2D and weight management, with the aim to deliver transformative treatments in metabolic health. Mazdutide is an analogue of oxyntomodulin (OXM), a natural peptide hormone existing in humans that activates both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), to scientifically and effectively reduce weight, increase energy expenditure, burn fat and improve liver fat metabolism. It can also achieve comprehensive metabolic benefits and improve physical health. The findings from GLORY-1 underscore mazdutide's impressive weight loss effects, safety and tolerability, and further highlight its ability to significantly reduce liver fat content and improve multiple cardiovascular metabolic risk factors. These results reaffirm the distinct advantages of new-generation of GLP-1R/GCGR dual agonists. Excellent weight loss efficacy The GLORY-1 study demonstrated mazdutide's remarkable weight loss efficacy. After 48 weeks of treatment, the mazdutide 6mg group experienced an average weight reduction of 14.3% compared to baseline. Additionally, mazdutide showed significant reductions in waist circumference, hip circumference, and neck circumference, indicating its potential in reducing body fat. Unprecedented liver benefits In addition to its exceptional weight management capabilities, mazdutide also demonstrated an 80.2% reduction in liver fat content in the GLORY-1 study, indicating improvements to liver health. Acting directly on the liver as a GLP-1R/GCGR dual agonist, mazdutide shows promise in treating metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH), enhancing liver metabolic function and mitigating factors contributing to liver metabolic dysfunction. Significant reduction in multiple cardiovascular metabolic risk indicators The data at week 48 showed that mazdutide outperformed placebo in reducing waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels compared to baseline. Furthermore, mazdutide significantly normalized blood sugar level for participants with HbA1C≥5.7%. These findings highlight mazdutide's potential to mitigate cardiovascular metabolic risk factors and improve blood sugar management. Well tolerated and favorable safety profile Mazdutide showed excellent safety and tolerability in the GLORY-1 study, establishing itself as a safe treatment choice. Most gastrointestinal symptoms observed in the treatment group, such as nausea, vomiting, and diarrhea, were mild or moderate, with no signals indicating increased cardiovascular risk. These findings underscore mazdutide's effectiveness in weight loss and improving metabolic conditions, while also highlighting its promising safety profile, positioning it as a potential best-in-class treatment option. The marketing application for mazdutide's first weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). If approved, mazdutide is positioned to be a safe, effective, and comprehensive solution for chronic weight management among obese and overweight individuals in China, and could aid them to improve liver fat metabolism and address obesity-related comorbidities. Moving forward, Innovent plans to explore additional indications for mazdutide, advance the research and development of next-generation GLP-1 products, and contribute to improving the quality of life for patients with chronic diseases. Additionally, Innovent discussed its products in the cardiovascular and metabolic (CVM) field targeting various clinical needs currently in development. SINTBILO® (PCSK9) is the first and only Chinese-developed PCSK9 monoclonal antibody approved for treating hyperlipidemia. IBI128 (a new xanthine oxidase inhibitor) represents a next-generation candidate for managing gout and hyperuricemia, with ongoing Phase 3 clinical trials overseas and planned Phase 1/2 studies in China starting in 2024. IBI3016 (AGT siRNA) is an innovative siRNA therapy for hypertension, with a Phase 1 clinical trial scheduled to commence in 2024. Furthermore, several early-stage projects are poised to enter the IND stage, bolstering Innovent's strategic positioning and competitive edge in CVM. Metabolic diseases significantly affect quality of life and overall well-being. Innovent is accelerating innovation in this crucial area, dedicated to addressing unmet clinical needs and delivering safer, more effective treatments to patients. Over the next five years, Innovent plans to introduce 5-6 new metabolic products targeting diabetes, weight loss, cardiovascular conditions and other indications, aiming to establish itself as a leading research and development company in the field of cardiovascular metabolic diseases in China. Autoimmune: addressing global unmet clinical needs In the field of autoimmune, Innovent has successfully launched SULINNO® (adalimumab injection), which is approved for eight indications including rheumatoid arthritis and psoriasis and is covered under the National Reimbursement Drug List. Picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, successfully met primary and key secondary endpoints in its Phase 3 clinical study (CLEAR-1) for moderate to severe plaque psoriasis in China. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients, and Innovent is preparing for a NDA submission to the CDE of NMPA. Innovent continues to explore unmet clinical needs in autoimmune diseases globally with advancements like IBI355 (CD40L), IBI356 (OX40L), IBI3002 (IL-4Rα/TSLP) and other innovative First-in-class/Best-in-class molecules targeting indications including primary Sjögren's syndrome, systemic lupus erythematosus, atopic dermatitis, asthma, and other diseases. Ophthalmology: advancing treatment standards In the field of ophthalmology, Innovent's new drug application for IBI311 Injection (recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, R&D) has been accepted for the treatment of thyroid eye disease (TED). This biologic with an innovative mechanism of action is poised to address a 60-year gap in domestic TED treatment, meeting significant clinical needs and offering effective, safe, and accessible treatment options for Chinese TED patients. In addition, Phase 3 clinical trials for IBI302 (VEGF/C) have commenced to address neovascular age-related maculopathy, with long-interval administration expected to achieve significant efficacy and potentially enhance management of geographic atrophy. Furthermore, IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are currently in Phase 1 clinical trials to explore their differentiated clinical value. 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 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, 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. Forward-Looking Statements 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, Inc. ("Innovent" or "Company"), 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 materialize or turn out to be incorrect. SOURCE Innovent Biologics

近日，信达生物在2024年美国糖尿病协会（ADA）科学会议上报告了胰高血糖素样肽-1受体（GLP-1R）/胰高血糖素受体（GCGR）双重激动剂玛仕度肽（研发代号：IBI362）在中国超重或肥胖成人受试者中的首个III期临床研究（GLORY-1）的主要结果及肝脏脂肪含量探索性终点结果。这是GLP-1R/GCGR双靶点在全球范围的首个减重III期临床结果。GLORY-1的研究结果亮眼，从强效减重、科学安全、独特的肝脏脂肪代谢和代谢指标全面改善等维度，再次印证了玛仕度肽双重激动GLP-1R/GCGR的独特优势。同时，信达生物正继续规划降糖减重之外的更多开发方向和更多创新分子的开发。 6月25日，信达生物召开投资者电话会，详细解读玛仕度肽临床数据。信达生物首席财务官由飞女士、综合管线临床开发副总裁钱镭博士参加会议并进行汇报。GLORY-1研究的牵头研究者、北京大学人民医院纪立农教授作为参会嘉宾做相关分享。 （详细分享材料可在公司官网进行下载，链接：https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/） 经过数年战略性布局，信达生物已经建立起涵盖心血管及代谢（CVM）、自身免疫、眼科等疾病领域的综合产品管线，确立了“为生命，更添美好”的综合管线品牌定位，为公司长期成长新添增长动力。尤其在CVM领域，通过系统制定平台架构及商业化策略，有序建立商业化能力、人员和配套支持，保障多款高潜力后期产品管线的价值释放，建立品牌形象和竞争优势。 CVM：树立品牌形象和长期耕耘， 玛仕度肽取得重要进展 玛仕度肽是基于人体天然激素的新一代双靶点GLP-1药物，科学强效减重，燃脂护肝，还能实现全面代谢获益，显著改善身体健康。 此次CVM领域重磅产品玛仕度肽GLORY-1的研究结果不仅证明了玛仕度肽优异的减重疗效，良好的安全性和耐受性，同时还观察到独特的肝脏脂肪含量大幅下降，以及多个心血管代谢风险指标的改善，再次印证了GLP-1R/GCGR双重激动剂的独特优势。 优异的减重疗效 在GLORY-1研究中展现了玛仕度肽卓越的减重效果。经过48周的治疗，玛仕度肽 6mg剂量组和基线对比相较安慰剂平均体重下降了14.3%，这一数据极具竞争力。与此同时，玛仕度肽在减少腰围、臀围和颈围方面也取得了明显成效，这表明了其在减少体脂方面的潜力。 独特的肝脏获益 不仅在体重管理方面表现出色，玛仕度肽还特别针对肝脏健康提供了显著获益。在玛仕度肽减重III期临床研究GLORY-1中，肝脏脂肪含量降幅高达80.2%。作为一种GLP-1R/GCGR双重激动剂，玛仕度肽直接作用于代谢性疾病中的核心器官——肝脏。它通过改善肝脏代谢功能和减少肝脏代谢功能障碍的因素，有潜力对抗与代谢功能相关的脂肪肝病（MASLD）和代谢相关的脂肪性肝炎（MASH）。 多个心血管代谢风险指标显著降低 数据显示，在第48周时，腰围、收缩压、甘油三酯、总胆固醇、LDL-C、血尿酸和ALT较基线的变化上，玛仕度肽均优于安慰剂，展示了玛仕度肽在降低心血管代谢风险因素和改善血糖控制方面的潜力。 耐受性和安全性良好 玛仕度肽在GLORY-1研究中展现了其安全性和耐受性，提供了一个安全的治疗选择。治疗组中观察到的胃肠道症状（如恶心、呕吐和腹泻）大多数是轻度或中度，没有观察到增加心血管风险的信号。这些结果表明，玛仕度肽不仅在减重和改善代谢疾病方面效果显著，而且在安全性方面也提供了令人鼓舞的数据，使其成为一个潜在的同类最佳的治疗选择。 玛仕度肽首个减重适应症的上市申请正在国家药品监督管理局（NMPA）药品审评中心（CDE）的审评中，有望为中国肥胖及超重人群提供安全、强效并全面改善心血管代谢的体重管理方案。下一步，信达生物将持续探索、扩大玛仕度肽的适应症范围，加强新一代GLP-1产品的研发，助力慢病患者改善生活质量。 除此之外，CVM领域还有针对不同临床需求的管线在开发中，信必乐®（PCSK9) 是唯一获批中国原研PCSK9单抗，治疗高脂血症。IBI128 (XOI)是新一代痛风高尿酸血症候选分子，海外MRCT 3期临床研究进行中，2024年启动中国1/2期临床研究。IBI3016（AGT siRNA）是新一代高血压小核酸疗法，2024年启动1期临床研究。另外，更多早期项目即将进入IND阶段，扩大CVM战略地位和竞争优势。 自身免疫：立足全球未满足的临床需求 在自身免疫领域，信达生物成功上市一款产品——苏立信®（阿达木单抗注射液），已获批类风湿关节炎、强直性脊柱炎、银屑病等八项适应症并均纳入国家医保。信达生物自主研发的重组抗白介素23p19亚基（IL-23p19）抗体注射液匹康奇拜单抗（研发代号：IBI112）在中国中重度斑块状银屑病受试者中开展的Ⅲ期临床研究（CLEAR-1）中达成主要终点和所有关键次要终点，是目前本靶点全球唯一一个首要研究终点（16周PASI90） 突破80%的银屑病三期注册临床研究，计划递交上市申请。IBI355(CD40L)、IBI356 (OX40L)、IBI3002 (IL-4Rα/TSLP)等特色创新性免疫分子进入临床，探索全球自免细分领域，包括原发性干燥综合征(pSS)、系统性红斑狼疮(SLE)、特应性皮炎(AD)、哮喘等疾病的未满足临床需求。 眼科：致力提升治疗标准 眼科领域，信达生物替妥尤单抗注射液（重组抗胰岛素样生长因子1受体（IGF-1R）抗体，研发代号：IBI311）的新药上市申请已获受理，用于甲状腺眼病（TED）的治疗。替妥尤单抗是中国首个申报上市的IGF-1R抗体，作为具有创新作用机制的生物药，有望填补国内TED治疗领域60年来无新药可用的空白，满足国内TED治疗的显著临床需求，为中国TED患者带来有效、安全、可及的治疗手段。IBI302 (VEGF/C)临床3期研究启动，治疗新生血管性年龄相关性黄斑病变，长间隔给药有望实现优异疗效，潜在改善地图样萎缩。IBI324（VEGF-A/ANG-2）、IBI333（VEGF-C/VEGF-A）处于临床1期研究阶段，探索差异化临床价值。 代谢类疾病高度影响老百姓的生活质量和幸福指数，信达生物将在该领域加速创新，致力于解决未满足的临床需求，为患者带来更安全、更有效的治疗方案。在未来5年内，信达生物预计将有5-6款代谢类产品上市，覆盖糖尿病、减重、心血管等适应症，立志成为在中国心血管代谢疾病领域有一定话语权的研发型企业。 关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域的创新药物。公司已有10款产品获得批准上市，同时还有4个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。公司与海内外药企深入合作加速药物创新，与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson癌症中心等国际合作方达成30多项战略合作。 信达生物在不断开发创新药物、谋求自身发展的同时，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。