SAN FRANCISCO and SUZHOU, China, May 8, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical trial (DREAMS-2) of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese subjects with type 2 diabetes (T2D) met the primary endpoint.

中国旧金山和苏州，2024年5月8日/PRNewswire/--Innovent Biologics，Inc.（Innovent）（香港交易所：01801），一家世界级的生物制药公司，开发，制造和商业化用于治疗肿瘤，自身免疫，心血管和代谢，眼科和其他主要疾病的优质药物，宣布在中国2型糖尿病（T2D）受试者中，胰高血糖素样肽-1受体（GLP-1R）和胰高血糖素受体（GCGR）双重激动剂马杜肽（Innovent R＆D代码：IBI362）的3期临床试验（DREAMS-2）符合原发性端点。

The study results suggested that mazdutide was superior compared with dulaglutide for glycaemic control, and mazdutide also showed multiple cardiometabolic benefits in T2D patients including weight loss, blood lipid, blood pressure, serum uric acid, liver enzymes, etc. .

研究结果表明，马杜肽在血糖控制方面优于杜拉鲁肽，并且马杜肽在T2D患者中也显示出多种心脏代谢益处，包括体重减轻，血脂，血压，血尿酸，肝酶等。

DREAMS-2 (ClinicalTrials.gov, NCT05606913) is a multi-center, randomized Phase 3 clinical study to compare the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with T2D who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with other oral drugs.

DREAMS-2（ClinicalTrials.gov，NCT05606913）是一项多中心随机3期临床研究，旨在比较马杜肽和杜拉鲁肽对二甲双胍单药治疗或二甲双胍与其他口服药物联合治疗血糖控制不足的中国T2D受试者的疗效和安全性。

The study enrolled 731 subjects to receive either mazdutide 4.0 mg, mazdutide 6.0 mg or dulaglutide 1.5 mg for 28 weeks. The primary endpoint was the change from baseline to week 28 in glycated hemoglobin (HbA1c) levels. The study used a non-inferiority design, and further superiority testing was performed after non-inferiority was achieved..

该研究招募了731名受试者，接受马珠肽4.0 mg，马珠肽6.0 mg或杜拉鲁肽1.5 mg治疗28周。主要终点是糖化血红蛋白（HbA1c）水平从基线到第28周的变化。该研究使用了非劣效性设计，并在达到非劣效性后进行了进一步的优势测试。。

The primary endpoint was successfully met, showing a robust glucose-lowering efficacy of mazdutide

主要终点得到了成功满足，显示了马杜肽强大的降糖功效

After 28 weeks of treatment, mazdutide 4.0 mg and mazdutide 6.0 mg showed non-inferiority to dulaglutide 1.5 mg in terms of improvement in HbA1c level from baseline. Based on these results, the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg..

治疗28周后，就HbA1c水平相对于基线的改善而言，马珠肽4.0 mg和马珠肽6.0 mg显示出不劣于杜拉鲁肽1.5 mg。基于这些结果，进一步进行了优势测试，马杜肽4.0 mg和6.0 mg均优于杜拉鲁肽1.5 mg。。

The key secondary endpoints showed mazdutide's superior benefits in both glucose-lowering and weight loss

关键的次要终点显示了马杜肽在降低血糖和减肥方面的优越优势

Statistical superiority was achieved in the following endpoints in both mazdutide 4.0 mg and mazdutide 6.0 mg groups after 28 weeks of treatment, including the change from baseline in HbA1c (superiority), percent change from baseline in body weight, proportion of subjects with HbA1c < 7.0% and weight loss of ≥ 5%, and proportion of subjects with HbA1c < 7.0%*..

在治疗28周后，马珠肽4.0 mg和马珠肽6.0 mg组的以下终点均达到统计学优势，包括HbA1c与基线的变化（优势），体重与基线的变化百分比，HbA1c<7.0%和体重减轻≥5%的受试者比例，以及HbA1c<7.0%的受试者比例*。。

Mazdutide showed comprehensive benefits beyond glucose-lowering and weight loss in multiple cardiometabolic indicators (blood pressure, blood lipids, serum uric acid, and liver enzymes)

马杜肽在多种心脏代谢指标（血压、血脂、血尿酸和肝酶）中显示出降糖和减肥以外的综合益处

Mazdutide also showed significant advantages compared with dulaglutide in various indicators, including the proportion of subjects with HbA1c ≤ 6.5%, changes in fasting blood glucose and seven-point fingerstick blood glucose from baseline, the proportion of subjects with body weight loss of ≥ 5% and ≥ 10%, absolute change in body weight from baseline, waist circumference, body mass index (BMI), systolic blood pressure (SBP), triglyceride (TG), serum uric acid (UA), alanine aminotransferase (ALT) and aspartate aminotransferase (AST), etc..

与杜拉鲁肽相比，马杜肽在各项指标上也显示出明显的优势，包括HbA1c≤6.5%的受试者比例，空腹血糖和七指血糖从基线的变化，体重减轻≥5%和≥10%的受试者比例，体重从基线的绝对变化，腰围，体重指数（BMI），收缩压（SBP），甘油三酯（TG），血尿酸（UA），丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）等。。

Favorable safety and tolerability profile

良好的安全性和耐受性

Gastrointestinal adverse reactions were the most common adverse events, most were mild to moderate in severity , transient, and mainly occurred during the first 12-week titration period.

胃肠道不良反应是最常见的不良事件，大多数严重程度为轻度至中度，短暂，主要发生在滴定的前12周。

No severe hypoglycemia occurred; the incidence of moderate or severe hypoglycemia was comparable to that of dulaglutide; and the incidence of hypoglycemia was lower in indirect comparison to reported in registrational studies of other GLP-1 drugs.

无严重低血糖发生；中度或重度低血糖的发生率与杜拉鲁肽相当；与其他GLP-1药物的注册研究报道的间接比较，低血糖的发生率较低。

No signal of increased cardiovascular risk throughout the treatment period, similar to dulaglutide.

与杜拉鲁肽相似，在整个治疗期间没有心血管风险增加的信号。

The overall safety profile was consistent with that observed in previous clinical studies of mazdutide and no new safety signals observed.

总体安全性与之前马杜肽临床研究中观察到的一致，没有观察到新的安全信号。

Mazdutide is the first GLP-1R/GCGR dual agonist in the regulatory review status, with the first new drug application (NDA) for chronic weight management under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). DREAMS-2, as one of the registrational clinical studies of mazdutide, will provide high-quality evidence of mazdutide for Chinese population with T2D.

Mazdutide是第一个处于监管审查状态的GLP-1R/GCGR双重激动剂，美国国家医疗产品管理局（NMPA）药物评估中心（CDE）正在审查第一个用于慢性体重管理的新药申请（NDA）。DREAMS-2作为马珠肽的注册临床研究之一，将为中国T2D人群提供马珠肽的高质量证据。

Innovent plans to read out the results of another DREAMS-1 Phase 3 clinical study in mid-2024 and submit to the CDE an NDA for the treatment of T2D with mazdutide. Detailed data from the DREAMS-1 and DREAMS-2 studies will be further analyzed and published at academic congresses or in clinical journals..

Innovent计划在2024年年中宣读另一项DREAMS-1 3期临床研究的结果，并向CDE提交一份NDA，用于用马杜肽治疗T2D。DREAMS-1和DREAMS-2研究的详细数据将在学术会议或临床期刊上进一步分析和发表。。

Professor Lixin Guo, the principal investigator of the clinical study, Department of Endocrinology in Beijing Hospital, said: 'In China, T2D patients often have a variety of chronic diseases as comorbidities, such as obesity, hyperlipidemia, coronary heart disease, hypertension and so on. Therefore, the management of T2D should take into consideration the improvements in blood glucose, blood lipid, blood pressure and other aspects.

北京医院内分泌科临床研究的首席研究员郭立新教授说：“在中国，T2D患者常伴有多种慢性疾病，如肥胖、高脂血症、冠心病、高血压等。因此，T2D的管理应考虑血糖、血脂、血压等方面的改善。

In endocrine and CVM areas, GLP-1-based drugs are the hotspot of research and development for the healthcare industry as well as for clinicians, especially multi-target drugs that are potentially more efficacious and can provide more metabolic benefits. DREAMS-2 is the first Phase 3 clinical study head-to-head with dulaglutide in China, which has high clinical significance and academic value.

在内分泌和CVM领域，基于GLP-1的药物是医疗保健行业以及临床医生研究和开发的热点，尤其是多靶点药物，这些药物可能更有效并且可以提供更多的代谢益处。DREAMS-2是国内首例与杜拉鲁肽直接接触的3期临床研究，具有较高的临床意义和学术价值。

The results of this study showed that mazdutide, compared with dulaglutide, has a stronger glycaemic lowering effect and favorable safety profile. More importantly, mazdutide provided more comprehensive benefits in weight loss, blood lipid, blood pressure, blood uric acid, liver enzymes and other aspects.

这项研究的结果表明，与杜拉鲁肽相比，马杜肽具有更强的降血糖作用和良好的安全性。更重要的是，马杜肽在减肥，血脂，血压，血尿酸，肝酶等方面提供了更全面的益处。

I look forward to the NDA submission of mazdutide in T2D, and wish it to benefit hundreds of millions of diabetic patients in China.'.

我期待着马杜肽在T2D中的NDA提交，并希望它能使中国数亿糖尿病患者受益。”。

Professor Yang Wenying, the principal investigator of the clinical study, Department of Endocrinology in China Japan Friendship Hospital, said: 'China has the largest number of T2D patients in the world, and the prevalence of T2D among adults in China has reached 11.9%. Together with other investigators of the DREAMS-2 study, I am pleased to see that mazdutide, as a new generation of GLP-1R/GCGR dual target agonist, has met the primary endpoint and demonstrated superiority in change from baseline in HbA1c and multiple metabolic benefits compared with dulaglutide.

中日友好医院内分泌科临床研究首席研究员杨文英教授说：“中国是世界上T2D患者最多的国家，中国成年人T2D患病率已达到11.9%。与DREAMS-2研究的其他研究人员一起，我很高兴地看到，作为新一代GLP-1R/GCGR双靶点激动剂的马杜肽已经达到了主要终点，并且与杜拉鲁肽相比，在HbA1c和多种代谢益处的基线变化方面表现出优越性。

DREAMS-2 is a landmark study as it is the first successful registrational study of a GLP-1R/GCGR dual target agonist in T2D. I believe that in the near future, mazdutide will provide a new and better choice for the treatment of type 2 diabetes in China.'.

DREAMS-2是一项具有里程碑意义的研究，因为它是T2D中GLP-1R/GCGR双靶点激动剂的首次成功注册研究。我相信在不久的将来，马杜肽将为中国治疗2型糖尿病提供一种新的更好的选择。”。

Dr. Lei Qian, Vice President of Clinical Development of Innovent, said: 'There is a huge population of diabetes in China. Innovative drugs that are more effective, safer and more convenient are urgently needed. In the DREAMS-2 study, mazdutide showed comprehensive superiority to dulaglutide, one of the most-described glucose-lowering drugs in the world.

Innovent临床开发副总裁雷茜博士说：“中国糖尿病人口众多。迫切需要更有效，更安全，更方便的创新药物。在DREAMS-2研究中，马杜肽显示出比杜拉鲁肽更全面的优势，杜拉鲁肽是世界上描述最多的降糖药物之一。

We will further analyze the study data, and strive to submit an NDA for T2D as soon as possible this year, so as to help more Chinese T2D patients to achieve target blood glucose levels and acquire metabolic benefits. At the same time, we look forward to the performance of mazdutide in the DREAMS-3 study, a head-to-head study with semaglutide.'.

我们将进一步分析研究数据，力争今年尽快提交T2D的NDA，以帮助更多中国T2D患者达到目标血糖水平并获得代谢益处。同时，我们期待着mazdutide在DREAMS-3研究中的表现，这是一项与semaglutide进行的头对头研究。”。

About Diabetes

关于糖尿病

According to the global overview of diabetes published by the International Diabetes Federation in 2021, China ranks first in the number of patients with diabetes globally, with an estimated number of more than 140 million in 2021 and 174 million in 2045 [1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, such as decreased visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation [2].

根据国际糖尿病联合会（International diabetes Federation）于2021年发布的《全球糖尿病概述》，中国在全球糖尿病患者人数中排名第一，2021年估计人数超过1.4亿，2045年估计人数为1.74亿。血糖控制不佳可导致不可逆的微血管和大血管并发症，如视力下降、失明、肾功能不全、周围神经病变、心肌梗死、中风和截肢（2）。

The high incidence of diabetes, with serious complications, are of serious threat to human health. At present, there are many therapeutic regimens for diabetes. In addition to effectively controlling blood glucose, the development of new hypoglycemic drugs has begun to include the additional benefits of weight loss, cardiovascular risk reduction and kidney protection for patients with diabetes [3]..

糖尿病发病率高，并发症严重，严重威胁人类健康。目前，糖尿病有许多治疗方案。除了有效控制血糖外，新型降糖药物的开发已经开始包括减轻体重，降低心血管风险和保护糖尿病患者肾脏的额外益处。。

About Mazdutide (IBI362)

关于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, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor.

Innovent与礼来公司（礼来）就GLP-1R和GCGR双重激动剂OXM3（也称为mazdutide）在中国的开发和潜在商业化签订了独家许可协议。作为哺乳动物氧调节蛋白（OXM）类似物，除了GLP-1受体激动剂对促进胰岛素分泌，降低血糖和减轻体重的作用外，马杜肽还可以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。

Mazdutide has demonstrated robust weight loss and glucose-lowering effects in clinical studies, as well as multiple cardio-metabolic benefits, including reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, liver fat content and improving insulin sensitivity. Currently, a total of five Phase 3 registrational studies are underway, including GLORY-1 (4 mg and 6 mg) in Chinese overweight or obese subjects, GLORY-2 (9 mg) in Chinese obese subjects, DREAMS-1, DREAMS-2, and DREAMS-3 (mazdutide in subjects with type 2 diabetes).

马杜肽在临床研究中表现出强大的减肥和降糖作用，以及多种心脏代谢益处，包括降低腰围，血脂，血压，血尿酸，肝酶，肝脏脂肪含量和改善胰岛素敏感性。目前，共有五项3期注册研究正在进行中，包括中国超重或肥胖受试者的GRONY-1（4 mg和6 mg），中国肥胖受试者的GRONY-2（9 mg），DREAMS-1，DREAMS-2和DREAMS-3（2型糖尿病受试者中的马杜肽）。

Among them, GLORY-1 study and DREAMS-2 study have reached the endpoints..

其中，GLORY-1研究和DREAMS-2研究已经达到终点。。

About Innovent

关于Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

Innovent是一家领先的生物制药公司，成立于2011年，其使命是提供所有人都能负担得起的高质量生物制剂。该公司发现、开发、制造和商业化治疗一些最难治疾病的创新药物。它的开创性疗法治疗癌症，心血管和代谢，自身免疫和眼部疾病。

Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center..

Innovent在市场上有10种产品，在NMPA审查下有3种新药应用，在III期或关键临床试验中有5种资产，在临床早期还有18种分子。Innovent与30多位全球医疗保健领导者合作，其中包括礼来、罗氏、赛诺菲、阿迪玛、Incyte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 www.innoventbio.com, or follow Innovent on Facebook and LinkedIn..

Innovent秉承“从诚信做起，通过行动取得成功”的座右铭，保持行业实践的最高标准，并合作推进生物制药行业，使一流的药物可以广泛使用。有关更多信息，请访问www.innoventbio.com，或在Facebook和LinkedIn上关注Innovent。。

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

声明：Innovent不建议使用任何未经批准的药物/适应症。

* Note: This is based on efficacy estimand. The study used efficacy estimand and treatment-regimen estimand for statistical analysis, and they showed a high degree of concordance in the conclusions.

*注意：这是基于疗效估计。该研究使用疗效评估和治疗方案评估进行统计分析，结果显示结论高度一致。

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声明，这些声明本质上具有重大风险和不确定性。与Innovent Biologics（“Innovent”）相关的“预期”、“相信”、“估计”、“期望”、“打算”等词语旨在识别某些此类前瞻性陈述。

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声明。。

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.

这些前瞻性陈述是基于公司管理层在做出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并不能保证未来的发展，并受到风险、不确定性和其他因素的影响，其中一些因素超出了公司的控制范围，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声明中包含的信息存在重大差异。。

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、董事和员工不承担（a）纠正或更新本网站中包含的前瞻性声明的义务；（b）如果任何前瞻性陈述没有实现或证明不正确，则不承担任何责任。

References:

参考文献：

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SOURCE Innovent Biologics

来源Innovent Biologics

Company Codes: HongKong:1801, OTC-PINK:IVBIY, HongKong:01801

公司代码：香港：1801，OTC-PINK：香港艾比：01801