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SAN FRANCISCO
旧金山
and SUZHOU,
和苏州,
China
中国
,
,
June 12, 2025
2025年6月12日
/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 diseases, announces that it will present multiple clinical study results of mazdutide at the American Diabetes Association's® (ADA) 85th Scientific Sessions in .
/PRNewswire/ -- 信达生物制药集团(“信达生物”)(港交所代码:01801),一家致力于开发、生产和销售用于治疗肿瘤、自身免疫、心血管和代谢疾病、眼科及其他重大疾病的高质量药物的世界级生物制药公司,宣布将在美国糖尿病协会(ADA)第85届科学会议上展示玛仕度肽的多项临床研究成果。
Chicago
芝加哥
, U.S. from
,来自美国
June 20 -23
6月20日 - 23日
. Innovent will orally present
. 信达将进行口头陈述
the first Phase 3 study of mazdutide in Chinese adults with T2D (DREAMS-1)
在中国成人T2D患者中进行的mazdutide首个III期研究(DREAMS-1)
. In addition, multiple exploratory MoA analyses of mazdutide as well as preclinical study of IBI3030 (PCSK9-GGG antibody-peptide-conjugate) will be showcased in poster presentations. Details are listed below:
此外,还将通过海报展示mazdutide的多项探索性作用机制(MoA)分析以及IBI3030(PCSK9-GGG抗体-肽偶联物)的临床前研究。详细信息如下:
Title: Mazdutide vs. Placebo as Monotherapy in Patients with Type 2 Diabetes (DREAMS-1)
标题:玛仕度肽与安慰剂作为单一疗法在2型糖尿病患者中的比较(DREAMS-1)
Abstract #
摘要 #
:
:
306-OR
306-OR
Presentation Form
表现形式
:
:
Oral presentation
口头报告
Time
时间
:
:
2025 June 23,
2025年6月23日,
14:15 PM
14:15 PM
– 14:30 PM(CST)
– 下午2:30(CST)
Presenter
主持人
:
:
Dr. Lei Qian, Innovent Biologics
雷谦博士,信达生物
Title:
标题:
A novel antibody-peptide conjugate targeting PCSK9
一种新型的靶向PCSK9的抗体-肽偶联物
,
,
GLP-1R
GLP-1R
,
,
GCGR
GCGR
,
,
GIPR improves cardiovascular risk markers in preclinical study
GIPR在临床前研究中改善心血管风险标志物
Abstract #
摘要 #
:
:
1886-LB
1886-LB
Presentation Form
表现形式
:
:
Poster presentation
海报展示
Time
时间
:
:
2025 June 22,
2025年6月22日,
12:30 PM
中午12点30分
– 1:30 PM(CST)
– 下午1:30(CST)
Presenter
主持人
:
:
Dr.
博士
Decheng Ren
任德成
, Innovent Biologics
信达生物
Title:
标题:
The Dual Glucagon and Glucagon-Like Peptide 1 Receptor Agonist Mazdutide Outbalanced Glucagon-Like Peptide 1 Receptor Agonist Semaglutide Monotherapy in Improving Mice Liver Fat Accumulation
双胰高血糖素和胰高血糖素样肽1受体激动剂马祖杜肽在改善小鼠肝脏脂肪积累方面优于胰高血糖素样肽1受体激动剂司美鲁肽单药治疗
Abstract #
摘要 #
:
:
777-P
777-P
Presentation Form
表现形式
:
:
Poster presentation
海报展示
Time
时间
:
:
2025 June 22,
2025年6月22日,
12:30 PM
中午12点30分
– 1:30 PM(CST)
– 下午1:30(CST)
Presenter
主持人
:
:
Dr.Tianpei Hong, Peking University Third Hospital
北京大学第三医院田培红医生
Title:
标题:
Effect of Mazdutide on MASH Fibrosis – Targeting the Liver-Gut Axis and Microbiome
Mazdutide对MASH纤维化的影响——靶向肝肠轴和微生物组
Abstract #
摘要 #
:
:
1616-P
1616-P
Presentation Form
表现形式
:
:
Poster presentation
海报展示
Time
时间
:
:
2025 June 22,
2025年6月22日,
12:30 PM
中午12点30分
– 1:30 PM(CST)
– 下午1点30分(CST)
Presenter
主持人
:
:
Professor
教授
Ling Li
李玲
, Zhongda Hospital Affiliated to Southeast University
东南大学附属中大医院
Title:
标题:
Mazdutide, a Dual GLP-1R/GCGRR Agonist, Reduces Hyperuricemia by Modulating Energy and Lipid Metabolism and Inhibiting Hepatic Purine Metabolism
Mazdutide,一种双重GLP-1R/GCGRR激动剂,通过调节能量和脂质代谢以及抑制肝脏嘌呤代谢来减少高尿酸血症
Abstract #
摘要 #
:
:
775-P
775-P
Presentation Form
表现形式
:
:
Poster presentation
海报展示
Time
时间
:
:
2025 June 22,
2025年6月22日,
12:30 PM
中午12点30分
– 1:30 PM(CST)
– 下午1:30(CST)
Presenter
主持人
:
:
Professor
教授
Hongwei Jiang
江宏伟
, The First Affiliated Hospital of
,第一附属医院
Henan
河南
University of Science and Technology
科学技术大学
Dr. Lei Qian, Vice President of Clinical Development of Innovent
雷谦博士,信达生物临床开发副总裁
, stated, 'We are honored to orally present the results of mazdutide's first Phase 3 clinical trial in T2D (DREAMS-1) at the ADA Scientific Sessions. We are also delighted to see mazdutide's mechanism exploration studies featured extensively at the conference. The growing body of medical evidence will further validate mazdutide's differentiated profile as a next-generation GCG/.
,表示:“我们很荣幸在ADA科学会议上口头报告了mazdutide针对2型糖尿病的首个III期临床试验(DREAMS-1)结果。同时,我们也非常高兴看到mazdutide作用机制的探索性研究在本次大会中被广泛展示。越来越多的医学证据将进一步验证mazdutide作为新一代GCG的独特特性。
GLP-1
GLP-1
dual receptor agonist, in particularly in liver fat and serum urine reduction. Moreover, in the field of cardiovascular and metabolic diseases, Innovent is dedicated to developing next-generation innovative therapies, including IBI3030(PCSK9-GGG)with novel modality and MoA, to meaningfully improve outcomes for more patients worldwide.'.
双受体激动剂,特别是在减少肝脏脂肪和血清尿素方面。此外,在心血管和代谢疾病领域,信达生物致力于开发下一代创新疗法,包括具有新颖模式和作用机制的IBI3030(PCSK9-GGG),以有意义地改善全球更多患者的治疗效果。'
About Mazdutide (IBI362)
关于玛仕度肽(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
信达与礼来公司就 GLP-1R 和 GCGR 双重激动剂 OXM3(也称为 mazdutide)的开发和潜在商业化签订了独家许可协议,
China
中国
. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of
作为一种哺乳动物氧磷素肽(OXM)类似物,mazdutide 可能提供超出以下的额外益处:
GLP-1
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.
受体激动剂——如促进胰岛素分泌、降低血糖和减轻体重——同时通过激活胰高血糖素受体来增加能量消耗并改善肝脏脂肪代谢。玛仕度肽在临床研究中展现出卓越的减重和降糖效果。
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..
它在减少腰围、血脂、血压、血尿酸、肝酶和肝脏脂肪含量以及改善胰岛素敏感性方面也显示出益处。
Currently, Mazdutide has two NDAs accepted for review by NMPA, including:
目前,玛仕度肽已有两项新药上市申请获中国国家药品监督管理局受理,包括:
Long-term weight management in adults with obesity or overweight.
成人肥胖或超重的长期体重管理。
Glycemic control in adults with type 2 diabetes (T2D).
成人2型糖尿病(T2D)的血糖控制。
Mazdutide is currently being evaluated in six Phase 3 clinical studies, including:
目前,玛仕度肽正在六项III期临床研究中进行评估,包括:
GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity.
GLORY-1:一项针对中国超重或肥胖参与者的III期临床试验。
GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity.
GLORY-2:一项针对中国中度至重度肥胖参与者的3期临床试验。
GLORY-3: A Phase 3 trial comparing Mazdutide and Semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD).
GLORY-3:一项比较玛仕度肽与司美格鲁肽在中国超重/肥胖及代谢功能障碍相关脂肪肝病(MAFLD)患者中的III期临床试验。
DREAMS-1: A Phase 3 trial in treatment-naïve Chinese participants with T2D.
DREAMS-1:一项针对未曾接受治疗的中国T2D患者的III期临床试验。
DREAMS-2: A Phase 3 trial comparing Mazdutide and Dulaglutide in Chinese T2D participants with inadequate glycemic control on oral antidiabetic drugs.
DREAMS-2:一项比较玛珠肽和度拉糖肽在中国口服降糖药控制不佳的2型糖尿病患者中的3期临床试验。
DREAMS-3: A Phase 3 trial comparing Mazdutide and Semaglutide in Chinese participants with T2D and obesity.
DREAMS-3:一项在中国T2D和肥胖患者中比较Mazdutide与Semaglutide的III期临床试验。
Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and others are currently ongoing.
其中,GLORY-1、DREAMS-1 和 DREAMS-2 已经达到了主要终点,其他研究正在进行中。
In addition, several new clinical studies of mazdutide are planned, including:
此外,还计划开展几项玛仕度肽的新临床研究,包括:
A Phase 3 trial in adolescents with obesity.
青少年肥胖的第三阶段试验。
New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF).
代谢功能障碍相关脂肪性肝炎(MASH)和射血分数保留的心力衰竭(HFpEF)的新研究。
About Innovent
关于信达
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.
信达生物是一家领先的生物制药公司,成立于2011年,其使命是为全球患者提供负担得起的高质量生物制药。公司致力于发现、开发、生产和商业化针对一些最棘手疾病的创新药物。其开创性疗法用于治疗癌症、心血管和代谢疾病、自身免疫性疾病以及眼科疾病。
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 Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center..
信达生物已上市15款产品,有3个新药申请处于监管审评中,4项资产处于III期或关键性临床试验中,还有15个分子处于早期临床阶段。信达生物与超过30家全球医疗保健公司合作,包括礼来、赛诺菲、Incyte、Adimab、LG化学和MD安德森癌症中心。
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
信达秉持“始于信,达于行”的理念,践行最高行业标准,与各界携手共进推动生物医药行业发展,让一流的生物药惠及更多患者。欲了解更多信息,请访问
www.innoventbio.com
www.innoventbio.com
, or follow Innovent on Facebook and LinkedIn.
,或者在Facebook和LinkedIn上关注信达。
Forward-looking statement
前瞻性声明
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.
本新闻稿可能包含某些前瞻性陈述,这些陈述因其性质而受到重大风险和不确定性的影响。与信达生物制药(“信达”)相关的诸如“预期”、“相信”、“估计”、“预计”、“意图”及类似表述的词语旨在识别其中某些前瞻性陈述。
The Company does not intend to update these forward-looking statements regularly..
公司不打算定期更新这些前瞻性陈述。
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.
这些前瞻性声明是基于公司管理层在作出这些声明时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并非对未来发展的保证,并且受风险、不确定性和其他因素的影响,其中一些因素超出公司的控制范围并且难以预测。
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..
因此,由于我们业务、公司竞争环境以及政治、经济、法律和社会条件的未来变化或发展,实际结果可能与前瞻性陈述中包含的信息有重大差异。
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.
公司、董事及公司的员工假定:(a) 没有义务更正或更新本网站中包含的前瞻性陈述;(b) 如果任何前瞻性陈述未能实现或证明是不正确的,也不承担任何责任。
SOURCE Innovent Biologics
来源:信达生物
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