ROCKVILLE, Md. and SUZHOU, China, Jan. 1, 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, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity.

美国马里兰州罗克维尔和中国苏州，2024年1月1日/PRNewswire/--Innovent Biologics，Inc.（Innovent）（香港交易所：01801），一家世界一流的生物制药公司，开发、制造和商业化用于治疗肿瘤、代谢、自身免疫、眼科和其他主要疾病的优质药物，宣布第一名参与者已在中国肥胖成年人中成功服用高剂量9 mg马珠肽（Innovent研发代码：IBI362），胰高血糖素样肽1受体（GLP-1R）和胰高血糖素受体（GCGR）双重激动剂的3期临床试验（GRORY-2）。

This is also the fourth large-scale phase 3 clinical study of mazdutide..

这也是马珠肽的第四项大规模3期临床研究。。

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GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.

GRORY-2计划招募450名受试者，随机接受马杜肽9 mg治疗或安慰剂治疗。主要终点包括从基线到第60周体重的百分比变化以及在第60周从基线体重减轻5%或更多的受试者的比例。

A Phase 2 study conducted in Chinese people with obesity with a BMI ≥ 30 kg/m2 (NCT04904913) showed that after 48 weeks of treatment, mazdutide 9mg achieved 18.6% placebo-adjusted mean percent reduction in body weight. Furthermore, mazdutide reduced waist circumference, blood pressure, lipids, serum uric acid, transaminase and liver fat, bringing multiple metabolic benefits to the subjects.

在BMI≥30 kg/m2的中国肥胖人群中进行的一项2期研究（NCT04904913）显示，经过48周的治疗，服用9mg马杜肽后，安慰剂调整后的平均体重减轻百分比为18.6%。此外，马杜肽降低了腰围，血压，血脂，血尿酸，转氨酶和肝脏脂肪，为受试者带来了多种代谢益处。

Mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs, with no new safety signals observed..

马杜肽的耐受性良好，总体安全性与其他GLP-1类药物相似，没有观察到新的安全信号。。

Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital, stated, 'Accumulated evidence showed that Chinese people generally have higher percentages of body fat and higher rates of cardiovascular risk factors and all-cause mortality than western population at given BMI levels, therefore overweight and obesity in adults in China are defined with lower BMI cutoffs (overweight cutoff BMI 24 kg/m2, obesity cutoff BMI 28 kg/m2).

北京大学人民医院首席研究员纪立农教授表示，“累积的证据表明，在给定的BMI水平下，中国人的体脂百分比、心血管危险因素和全因死亡率通常高于西方人群，因此，中国成年人的超重和肥胖定义为BMI临界值较低（超重临界BMI 24 kg/m2，肥胖临界BMI 28 kg/m2）。

The number of people with obesity with a BMI over 30 kg/m2 in China is huge and still increasing yearly. This subgroup of people with obesity, bear a greater burden of cardiovascular and metabolic diseases. They require special attention in clinical weight management and early prevention and treatment of metabolic syndrome[i], whereas the effective drug treatment options are limited.

在中国，体重指数超过30公斤/平方米的肥胖人群数量巨大，并且仍在逐年增加。这一肥胖人群承担着更大的心血管和代谢疾病负担。它们在临床体重管理和代谢综合征的早期预防和治疗中需要特别注意，而有效的药物治疗选择是有限的。

The mazdutide 9 mg Phase 2 study in Chinese people with obesity with a BMI ≥30 kg/m2 demonstrated strong weight loss efficacy, multiple cardiovascular metabolism improvements as well as a good safety profile[ii]. Mazdutide is potentially the first weight loss drug in China targeting people with more severe obesity.

在BMI≥30 kg/m2的中国肥胖人群中进行的马珠肽9 mg 2期研究显示出强大的减肥功效，多种心血管代谢改善以及良好的安全性。马杜肽可能是中国第一种针对肥胖程度更严重人群的减肥药。

I will work with the researchers of GLORY-2 to promote and complete this study, hoping to provide high-quality clinical evidence for weight loss research and bring better treatment options to Chinese patients with moderate to severe obesity.'Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, 'Different dosage regimens of mazdutide are suitable for different groups of people with obesity.

我将与GLORY-2的研究人员一起推动和完成这项研究，希望为减肥研究提供高质量的临床证据，并为中国中重度肥胖患者带来更好的治疗选择。”Innovent临床开发副总裁雷茜博士表示，“不同剂量的马珠肽适合不同的肥胖人群。

Mazdutide 9 mg is specifically developed to meet the weight loss needs of people with moderate to severe obesity with a BMI above 30 kg/m2 in China. In a phase 2 study, mazdutide 9 mg showed a more than 18% placeb.

Mazdutide 9 mg是专门为满足中国BMI超过30 kg/m2的中度至重度肥胖人群的减肥需求而开发的。在一项2期研究中，马杜肽9 mg显示出超过18%的安慰剂。

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

[i] 中国城乡的体重指数和肥胖：2004-18年连续全国代表性调查的结果

[ii] https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=407

[ii]https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=407

[iii] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.

[iii]Pan XF，Wang L，Pan A.中国肥胖的流行病学和决定因素。柳叶刀糖尿病内分泌2021；9： 373年至92年。

[iv] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).

[四]卫生计量与评估研究所。全球卫生数据交换。GBD结果工具。http://ghdx.healthdata.org/gbd-resultstool（2021年1月10日访问）。

SOURCE Innovent Biologics

来源Innovent Biologics