SAN FRANCISCO

旧金山

and SUZHOU,

和苏州，

China

中国

,

，

June 15, 2025

2025年6月15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, cardiovascular and metabolic, autoimmune, ophthalmology and other major disease areas, announced that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-OSA) of mazdutide, a dual glucagon (GCG) and glucagon-like peptide-1 (.

/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、心血管及代谢疾病、自身免疫、眼科及其他重大疾病领域的高质量药物的世界级生物制药公司，宣布其双靶点胰高血糖素（GCG）和胰高血糖素样肽-1（GLP-1）候选药物mazdutide的III期临床试验（GLORY-OSA）已完成首例受试者给药。

GLP-1

GLP-1

) receptor agonist, in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity (BMI ≥ 28 kg/m

) 受体激动剂，用于中国中重度阻塞性睡眠呼吸暂停 (OSA) 和肥胖 (BMI ≥ 28 kg/m 的患者

2

2

). This is the seventh Phase 3 clinical study of mazdutide in

）。这是玛珠度肽的第七项III期临床研究

China

中国

, continuing to explore its potential in managing obesity and a range of metabolic syndromes, with the aim of generating more comprehensive and high-quality evidence to support clinical application.

，继续探索其在管理肥胖和一系列代谢综合征方面的潜力，旨在生成更全面、更高质量的证据以支持临床应用。

GLORY-OSA is a multicenter, randomized, double- blinded Phase 3 clinical study (NCT06931028) comparing the efficacy and safety of mazdutide 9mg versus placebo in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity (BMI ≥ 28 kg/m2). The primary endpoint is the change in apnea-hypopnea index (AHI) from baseline to Week 48..

GLORY-OSA是一项多中心、随机、双盲的III期临床研究（NCT06931028），比较了玛仕度肽9mg与安慰剂在中国中重度阻塞性睡眠呼吸暂停（OSA）和肥胖（BMI ≥ 28 kg/m²）患者中的疗效和安全性。主要终点是从基线到第48周睡眠呼吸暂停低通气指数（AHI）的变化。

Globally, an estimated 425 million people aged 30 to 69 live with moderate-to-severe OSA, with

全球范围内，估计有4.25亿30至69岁的人患有中度至重度的OSA，

China

中国

bearing the highest burden at approximately 66 million cases

承担着约6600万例的最高负担

[1]

[1]

. However, the diagnosis rates remain critically low, with less than 1% in

然而，诊断率仍然极低，低于1%。

China

中国

and only 20% in the U.S.

并且在美国只有20%

[2],[3]

[2],[3]

The condition disproportionately affects individuals living with obesity, with a prevalence of 40%, increasing to 80.5% among those undergoing bariatric surgery

该病症在肥胖人群中占比高达40%，而在接受减重手术的患者中，这一比例上升至80.5%。

[4],[5]

[4],[5]

. OSA-associated co-morbidities, including hypertension, cardiac arrhythmias, stroke, and metabolic syndrome, are strongly correlated with OSA severity

与OSA相关的共病，包括高血压、心律失常、中风和代谢综合征，与OSA的严重程度密切相关。

[6],[7]

[6],[7]

.

。

Positive airway pressure (PAP) is the first-line treatment for OSA, and certain patients experience transformative benefits from PAP. Challenges exist, however, as many others are unable to accept or adhere to PAP treatment due to the burdensome nature of the therapy. Moreover, current evidence does not strongly support a direct link between PAP and improved cardiometabolic outcomes (e.g., mortality, hypertension, myocardial infarction, stroke).

气道正压通气（PAP）是OSA的一线治疗方法，某些患者从PAP中获得了显著的益处。然而，挑战依然存在，因为许多其他患者由于该疗法的负担性而无法接受或坚持PAP治疗。此外，目前的证据并未强有力地支持PAP与改善心血管代谢结果（如死亡率、高血压、心肌梗死、中风）之间存在直接联系。

[8]

[8]

. Recently, the FDA approved Zepbound

最近，FDA批准了Zepbound。

®

®

(tirzepatide), a dual

（替西帕肽），双重

GLP-1

GLP-1

and glucose-dependent insulinotropic polypeptide (GIP) agonist, as the first and only prescription medicine for moderate-to-severe OSA in adults with obesity

作为一种葡萄糖依赖性促胰岛素多肽（GIP）激动剂，是首个也是唯一用于治疗肥胖成人中重度阻塞性睡眠呼吸暂停（OSA）的处方药。

[9]

[9]

. There is currently no approved treatment for OSA in

目前尚无批准的OSA治疗方法

China

中国

[1]

[1]

, highlighting a significant unmet medical need. The literature suggests

，突显了显著未满足的医疗需求。文献表明

[10],[11],[12]

[10],[11],[12]

that a 10% reduction in weight is associated with a 26% decrease in AHI, and that each 1-unit reduction in BMI corresponds to a 2-3 unit decrease in AHI. As such, weight loss medications have emerged as potential treatments for OSA.

体重减轻10%与AHI降低26%相关，且BMI每减少1个单位，AHI相应减少2-3个单位。因此，减肥药物已成为OSA的潜在治疗方法。

Professor Tianpei Hong, the Principal Investigator of the Study, Peking University Third Hospital

北京大学第三医院研究员、首席研究员洪天配教授

, stated, 'Patients with untreated OSA face significantly increased risks of cardiovascular diseases, metabolic disorders, neurocognitive decline, and traffic accidents. Their quality of life and labor capacity are often severely hampered. The OSA proportion of patients living with obesity is large and grows year after year.

，指出：“未经治疗的阻塞性睡眠呼吸暂停患者面临显著增加的心血管疾病、代谢紊乱、神经认知衰退和交通事故风险，其生活质量和劳动能力往往受到严重阻碍。肥胖症患者的阻塞性睡眠呼吸暂停比例较大，并且逐年增加。

Despite this, an effective drug treatment regimen for OSA is lacking in .

尽管如此，OSA 仍缺乏有效的药物治疗方案。

China

中国

[13]

[13]

. In our Phase 3 study GLORY-1

在我们的三期研究 GLORY-1 中

[14]

[14]

, mazdutide showed good weight loss efficacy with multi-cardiovascular metabolism improvement, and a well-tolerated safety profile, which positions mazdutide as the world's first dual GCG/

，玛仕度肽展现出良好的减重效果，同时改善了多种心血管代谢指标，并且具有良好的安全性，这使得玛仕度肽成为全球首个双重GCG/

GLP-1

GLP-1

receptor targeted drug for patients with OSA and obesity. I will work closely with the GLORY-OSA research team to ensure the successful and high-quality completion of this study, with the ultimate goal of obtaining robust clinical evidence and expanding treatment options for Chinese patients with moderate-to-severe OSA and obesity.'.

针对OSA和肥胖患者的受体靶向药物。我将与GLORY-OSA研究团队密切合作，确保这项研究成功且高质量地完成，最终目标是获取强有力的临床证据，并为中国中重度OSA和肥胖患者拓展治疗选择。"

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent

礼骞，信达生物临床开发高级副总裁

, stated, 'We have developed different doses and regimens of mazdutide to address the diverse treatment needs of patients with different indications. The development of mazdutide for OSA specifically targets the treatment needs of Chinese patients with moderate-to-severe OSA and obesity (BMI ≥ 28 kg/m.

，表示：“我们开发了不同剂量和方案的玛仕度肽，以满足不同适应症患者的多样化治疗需求。针对中重度阻塞性睡眠呼吸暂停（OSA）伴肥胖（BMI ≥ 28 kg/m²）的中国患者，玛仕度肽的开发正是为了满足这一特定群体的治疗需求。

2

2

). In a Phase 2 study, mazdutide 9 mg achieved an 18.6 % weight loss compared to placebo, along with notable cardiovascular and metabolic benefits. The 9 mg regimen also features a simple titration schedule and a favorable safety profile. We are optimistic that the GLORY-OSA study will further validate mazdutide's powerful efficacy and good safety, and provide a promising pharmacologic alternative to PAP, the current standard of care for patients with moderate-to-severe OSA.'.

在一项二期研究中，与安慰剂相比，玛祖肽9毫克实现了18.6%的体重减轻，并带来了显著的心血管和代谢益处。9毫克方案还具有简单的滴定计划和良好的安全性。我们乐观地认为，GLORY-OSA研究将进一步验证玛祖肽的强大疗效和良好安全性，并为目前中重度阻塞性睡眠呼吸暂停（OSA）患者的护理标准——持续气道正压通气（PAP）提供一种有前景的药物替代方案。"

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，在

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调节素（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——例如促进胰岛素分泌、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 for:

目前，玛仕度肽已有两项新药上市申请（NDA）获国家药品监督管理局（NMPA）受理并正在审评中，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 seven Phase 3 clinical studies, including:

目前，玛仕度肽正在进行七项III期临床研究，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III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。

GLORY-OSA: A Phase 3 trial in Chinese participants with OSA and obesity.

GLORY-OSA：一项针对中国OSA和肥胖患者的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-2：一项针对口服降糖药控制不佳的中国2型糖尿病患者，比较mazdutide和dulaglutide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-3：一项比较玛珠肽和司美格鲁肽在中国T2D和肥胖患者中的III期临床试验。

Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing.

其中，GLORY-1、DREAMS-1 和 DREAMS-2 已经达到了主要终点，另外四项研究目前正在开展中。

In addition, several new clinical studies of mazdutide are initiated or planned, including:

此外，玛仕度肽的数项新临床研究已经启动或正在计划中，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价格合理、高质量的生物制药。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。其开创性疗法治疗癌症、心血管和代谢疾病、自身免疫和眼科疾病。

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 Eli Lilly, Sanofi, Incyte, 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查阶段，4项资产处于III期或关键临床试验阶段，还有15种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、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

秉承“诚信为本，行动致胜”的理念，信达生物坚持最高的行业标准，协同合作推进生物制药行业的发展，使一流的药物能够广泛普及。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（“信达”）相关的诸如“预期”、“相信”、“估计”、“预计”、“意图”等词语及类似表达，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，且受风险、不确定性及其他因素的影响，其中部分因素超出公司的控制范围且难以预测。

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、法律和社会状况的未来变化或发展，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、董事及公司的员工：(a) 没有义务更正或更新本网站所包含的前瞻性陈述；(b) 如果任何前瞻性陈述未能实现或证明不正确，概不承担任何责任。

References

参考文献

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[2] Zhang Y, et al. Underdiagnosis of Sleep Apnea in China: A Call for Public Health Action. Chest. 2022;161(2):418-426.

[2] 张毅等。中国睡眠呼吸暂停的诊断不足：呼吁公共卫生行动。《胸部》。2022；161（2）：418-426。

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[9]

[9]

https://lilly.mediaroom.com/2024-12-20-FDA-approves-Zepbound-R-tirzepatide-as-the-first-and-only-prescription-medicine-for-moderate-to-severe-obstructive-sleep-apnea-in-adults-with-obesity

https://lilly.mediaroom.com/2024-12-20-FDA批准Zepbound-R替西帕肽作为首个也是唯一一个用于治疗肥胖成人中重度阻塞性睡眠呼吸暂停的处方药

[10] Araghi MH, et al. Sleep. 2013 Oct 1;36(10):1553-62, 1562A-1562E.

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[12] Romero-Corral A, 等。《胸部》。2010年3月；137(3):711-9。

[13] Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004–18

[13] 2004-2018年中国城乡地区身体质量指数与肥胖：基于连续全国代表性调查的发现

[14] Ji L, et al. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528.

[14] 姬琳等。每周一次玛祖肽在中国肥胖或超重成人中的应用。《新英格兰医学杂志》。2025年6月12日；392（22）：2215-2225。doi: 10.1056/NEJMoa2411528。

SOURCE Innovent Biologics

来源：信达生物

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