Dulaglutide

SAN FRANCISCO and SUZHOU, China, May 15, 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 oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in GLORY-3, a Phase 3 clinical study of mazdutide (Innovent R&D Code: IBI362), a dual glucagon (GCG) and glucagon-like peptide 1 receptor (GLP-1) receptor agonist. The study targets adults in China with overweight or obesity accompanied metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-3 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06884293) comparing the efficacy and safety of mazdutide versus semaglutide in Chinese adults with overweight or obesity accompanied MAFLD. This study plans to enroll approximately 470 participants with overweight or obesity (BMI ≥ 27 kg/m2) accompanied MAFLD, who will be randomized 1:1 to receive mazdutide 9 mg or semaglutide 2.4 mg. The primary endpoints are the percentage change in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction (MRI-PDFF) and the percentage change in body weight from baseline to week 48. A Phase 2 study conducted in Chinese adults with obesity (BMI ≥ 30 kg/m2, NCT04904913) showed that after 48 weeks of treatment, mazdutide 9 mg achieved an 18.6% (17.8kg) placebo-adjusted mean percent reduction in body weight. Meanwhile, 51.2% and 34.9% of the subjects in the mazdutide 9 mg group achieved 15% or more and 20% or more weight loss from baseline, respectively. Among participants with baseline LFC≥ 5% (measured by MRI-PDFF), the percent change in LFC from baseline to week 24 was reduced by 73.3% in the mazdutide 9 mg group. This decrease was sustained during the 48-week extended treatment period, suggesting that mazdutide can effectively reduce body weight and liver fat in participants with overweight or obesity. Professor Lixin Guo, the Principal Investigator of the Study, Peking University People's Hospital, stated, "MAFLD is now the most common chronic liver disease in the world and has surpassed viral hepatitis as the leading chronic liver disease in China. Obesity is a key risk factor, with MAFLD affecting up to 81.8% people with obesity in China[1]. The latest Chinese guidelines recommended GLP-1 agents such as semaglutide for treating obesity and MAFLD ('Guideline for chronic weight management and clinical practice of anti-obesity medications'). As a dual GCG/GLP-1 receptor agonist, mazdutide 9 mg has shown strong weight loss effects and notable improvements in liver fat and enzyme levels, thanks to its additional GCG activity. GLORY-3 is the first clinical trial comparing a dual GCG/GLP-1 receptor agonist with a GLP-1R-only drug in Chinese adults with obesity. It will compare the efficacy and safety of mazdutide 9 mg versus semaglutide 2.4 mg in participants with overweight or obesity accompanied MAFLD. Together with our investigator team, I am committed to conducting this study to the highest standards and to delivering a better treatment option for the Chinese population with overweight or obesity accompanied MAFLD." Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, stated, "Mazdutide, as a dual GCG/GLP-1 receptor agonist, enhances lipolysis and fatty acid oxidation by stimulating the GCG receptor, offering a series of comprehensive metabolic benefits compared to GLP-1 single receptor agonist drugs. In our Phase 2 study conducted in Chinese adults with obesity, participants with baseline LFC ≥ 5% had a 73.3% reduction in liver fat content after 24 weeks of treatment with mazdutide 9 mg, which preliminarily demonstrated the efficacy of mazdutide in reducing liver fat content. I am very confident that mazdutide will continue to show strong clinical efficacy in the GLORY-3 study, including in weight loss and liver metabolism, and provide a better treatment option for Chinese patients with overweight or obesity accompanied MAFLD." About Obesity China has the world's largest population of people with overweight or obesity[2], with the obesity rate likely to rise. Obesity contributes to multiple comorbidities, reducing life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths related from chronic non-communicable diseases in China, a significant increase from 5.7% in 1990[3]. As obesity is a chronic disease, it requires long-term management, and China faces a lack of long-term effective and safe treatments. Despite lifestyle interventions being the first-line treatment, many patients fail to achieve their desired weight loss goals, underscoring the need for more effective and safer pharmacological interventions. About MAFLD MAFLD is the most common chronic liver disease worldwide, with a global prevalence estimated around 32.4% and increasing. Obesity is one of the risk factors for MAFLD, and the prevalence of MAFLD in those with obesity worldwide has reached 75.3%. In China, MAFLD has overtaken viral hepatitis as the leading chronic liver condition, affecting 81.8% of obese individuals[1]. China also has the world's highest incidence of MAFLD in both normal and obese populations. Treatment goals include reducing body weight and waist circumference, improving insulin resistance, preventing and treating metabolic-related syndromes, and reversing fibrosis. For patients with MAFLD and overweight or obesity, combining lifestyle and pharmacological interventions is considered the most effective strategy to improve health outcomes and quality of life. About Mazdutide (IBI362) Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide currently has two NDAs accepted for review by NMPA, including: For chronic weight management in adults with overweight of obesity; For glycemia control in adults with type 2 diabetes. Mazdutide is currently being evaluated in six Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity. GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). DREAMS-1: A Phase 3 trial in treatment-naïve Chinese patients with T2D. DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D patients with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese patients with T2D and obesity. Among these, GLORY-1, DREAMS-1 and DREAMS-2 studies have all met their endpoints. In addition, several new clinical studies of mazdutide are planned, including: A Phase 3 trial in adolescents with obesity. A Phase 3 trial in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity. New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III 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, 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. Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. 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 [1] Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399. [2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92. [3] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. (accessed Jan 10, 2021). 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

GLP1类药物，绝对是全球最大热门。当前全球已上市的药物市场，主要是诺和诺德的司美格鲁肽和礼来的替尔泊肽之间的较量。而在国内市场，由于市场准入条件不同，价格，再加上咱们的特色情况，GLP1市场情况有点复杂。目前，国内共有11款GLP1类药品获批上市，每个产品各有特点，市场表现各不相同。这篇文章，就简单分享下这些产品的市场销售表现。1、艾塞那肽/艾塞那肽微球艾塞那肽注射液最早上市的GLP1，曾经，国内医院市场的销售额也超过1亿元，但毕竟硬伤太多，很快被利拉鲁肽、度拉糖肽拍死在沙滩上。2023年销售额跌倒两千万元。这个产品还有两个国产仿制，不知当年仿制药企业立项时，有没有注意到利拉鲁肽和司美格鲁肽的进展。艾塞那肽微球已被放弃，2022年后没有销售。2、利拉鲁肽注射液诺和诺德一出手，全球市场迅速碾压艾塞那肽，只是这几年在司美格鲁肽上市后，销售额才有所下降。中国市场和还在增长，医院市场最高销额接近20亿。国内已有中美华东、通化东宝、正大天晴、珠海联邦4个仿制获批。考虑到本品在基药目录以及国内的支付能力，未来，这个产品在中低端市场，仍然还有生命力。3、贝那鲁肽注射液国产首个GLP-1新药，当别人已经在开发一周一次的长效产品时，贝那鲁肽一天3次给药，竟然被获批了，竟然还获批了降糖、减重两个适应症，竟然医院市场还能有小几百万的销售额，这真是个奇迹啊。4、利司那肽注射液每日一次短效，降糖效果没有优势，心血管结局试验失败，利司那肽的失败，不可避免。赛诺菲也基本放弃了该产品。全球市场、国内市场销售也都基本清零。5、度拉糖肽注射液每周一次的长效制剂，明确的心血管获益证据。国内上市后销售额暴涨，已超过11亿元。6、聚乙二醇洛塞那肽注射液豪森的国产长效制剂，此前的市场销售还算给力吧！后面随着司美格鲁肽、替尔泊肽，以及国产新药上市，压力很大。7、司美格鲁肽注射液/片司美格鲁肽注射液绝对的王者，仅有降糖适应症在医保，也阻止不了产品大爆发，2024年去年预计超50亿元。司美格鲁肽片获批不久，暂无销售数据。8、替尔泊肽注射液2024年5月首次获批，降糖、减重两大适应症均已获批，和司美格鲁肽必有一战。9、依苏帕格鲁肽α注射液又一个国产长效GLP1，今年新获批，如果没有头对头的强有力临床数据，推广难度也不小啊。用摩熵药筛小程序，快速查询产品信息。