A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects

The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and <18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.

开始日期2024-08-01

申办/合作机构

信达生物制药（苏州）有限公司

NCT06519656 / Recruiting临床1/2期IIT

A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

开始日期2024-07-20

申办/合作机构

复旦大学附属中山医院

100 项与玛仕度肽相关的临床结果

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100 项与玛仕度肽相关的转化医学

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100 项与玛仕度肽相关的专利（医药）

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项与玛仕度肽相关的文献（医药）

2024-01-01·Diabetes care

Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Article

作者: Wang, Xiaoyun ; Cheng, Zhifeng ; Jin, Ping ; Qian, Lei ; Ye, Shandong ; Yang, Wenying ; Gu, Xuejiang ; Zhang, Xin ; Gan, Shenglian ; Ma, Jianhua ; Deng, Huan ; Wang, Guixia ; Shi, Bimin ; Ma, Guoqing ; Li, Haoyu ; Sun, Juan ; Li, Li ; Ma, Qingyang ; Liu, Dexue ; Ji, Linong ; An, Pei ; Zhang, Bo ; Jiang, Hongwei ; Yu, Ting ; Chen, Ji ; Yi, Jianjun

OBJECTIVE:

We conducted a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the efficacy and safety of mazdutide, a once-weekly glucagon-like peptide 1 and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS:

Adults with type 2 diabetes inadequately controlled with diet and exercise alone or with stable metformin (glycated hemoglobin A1c [HbA1c] 7.0–10.5% [53–91 mmol/mol]) were randomly assigned to receive 3 mg mazdutide (n = 51), 4.5 mg mazdutide (n = 49), 6 mg mazdutide (n = 49), 1.5 mg open-label dulaglutide (n = 50), or placebo (n = 51) subcutaneously for 20 weeks. The primary outcome was change in HbA1c from baseline to week 20.

RESULTS:

Mean changes in HbA1c from baseline to week 20 ranged from −1.41% to −1.67% with mazdutide (−1.35% with dulaglutide and 0.03% with placebo; all P < 0.0001 vs. placebo). Mean percent changes in body weight from baseline to week 20 were dose dependent and up to −7.1% with mazdutide (−2.7% with dulaglutide and −1.4% with placebo). At week 20, participants receiving mazdutide were more likely to achieve HbA1c targets of <7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol) and body weight loss from baseline of ≥5% and ≥10% compared with placebo-treated participants. The most common adverse events with mazdutide included diarrhea (36%), decreased appetite (29%), nausea (23%), vomiting (14%), and hypoglycemia (10% [8% with placebo]).

CONCLUSIONS:

In Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reductions.

2022-12-01·EClinicalMedicine

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial

Article

作者: Deng, Huan ; Wen, Jie ; Gao, Leili ; Jiang, Hongwei ; Feng, Liqi ; Yu, Lei ; Ma, Qingyang ; Song, Baili ; Ji, Linong ; Cai, Chenghang ; Yang, Jing ; Qian, Lei

Background:

Mazdutide (also known as IBI362 or LY3305677), a novel once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, achieved 12-week body weight loss up to 6.4% at doses up to 6 mg in Chinese adults with overweight or obesity. We further explored the safety and efficacy of mazdutide dosed up to 9 mg and 10 mg.

Methods:

In this randomised, placebo-controlled, multiple-ascending-dose phase 1b trial, we enrolled adults (aged 18-75 years, both inclusive) with overweight (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m²) from five hospitals in China. Eligible participants were randomly assigned (2:1) within each cohort by using an interactive web-response system to receive once-weekly subcutaneous mazdutide or placebo for 12 weeks in the 9 mg cohort (3 mg weeks 1-4; 6 mg weeks 5-8; 9 mg weeks 9-12) and for 16 weeks in the 10 mg cohort (2.5 mg weeks 1-4; 5 mg weeks 5-8; 7.5 mg weeks 9-12; 10 mg weeks 13-16). The participants, investigators, study site personnel involved in treating and assessing participants in each cohort and sponsor personnel were masked to treatment allocation. The primary outcomes were safety and tolerability of mazdutide, assessed from baseline to end of follow-up in all participants who received at least one dose of the study treatment. The secondary outcomes included the change from baseline to week 12 or week 16 in body weight, waist circumference and BMI. This trial is registered with ClinicalTrials.gov, NCT04440345.

Findings:

Between Mar. 1, 2021 and Mar. 26, 2021, a total of 24 participants were enrolled, with eight randomly assigned to mazdutide and four to placebo in each cohort. One participant receiving mazdutide and two receiving placebo in the 10 mg cohort withdrew consent and quitted the study. No serious adverse event was reported. All treatment-emergent adverse events (TEAEs) were mild or moderate in severity and most commonly-reported TEAEs were upper respiratory tract infection, diarrhoea, decreased appetite, nausea, urinary tract infection, abdominal distension and vomiting. The mean percent change from baseline to week 12 in body weight were -11.7% (SE 1.5) for participants receiving mazdutide in the 9 mg cohort and -1.8% (1.6) for participants receiving placebo (estimated treatment difference [ETD]: -9.8%; 95% confidence interval [CI]: -14.4, -5.3; P = 0.0002). The mean percent change from baseline to week 16 in body weight were -9.5% (SE 1.7) for participants receiving mazdutide in the 10 mg cohort and -3.3% (1.9) for participants receiving placebo (ETD: -6.2%; 95% CI: -11.5, -0.9; P = 0.024). In addition, compared with placebo, mazdutide achieved more profound reductions in waist circumference and BMI.

Interpretation:

Mazdutide dosed up to 9 mg and 10 mg was both well tolerated and showed a favourable safety profile. High-dose mazdutide showed promising 12-week body weight loss, holding great potential for the treatment of moderate-to-severe obesity. A larger and longer phase 2 trial will further evaluate the efficacy and safety of high-dose mazdutide in Chinese adults with obesity.

Funding:

Innovent Biologics, Inc.

2021-09-01·EClinicalMedicine

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study

Article

作者: Qian, Lei ; Han-Zhang, Han ; Song, Baili ; Feng, Liqi ; Jiang, Hongwei ; An, Pei ; Deng, Huan ; Ma, Qingyang ; Liu, Meng ; Li, Li ; Ji, Linong

BACKGROUND:

IBI362 (LY3305677) is a novel weekly-dose glucagon-like peptide-1 and glucagon receptor dual agonist being developed for the treatment of obesity and type 2 diabetes. The aim of this randomised, placebo-controlled, multiple ascending dose phase 1b study was to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI362 in Chinese adults with overweight or obesity.

METHODS:

This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m²) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m²) from six study centres in China. Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up. The dose-escalation regimens were: 3.0 mg cohort (1.0 mg weeks 1-4; 2.0 mg weeks 5-8; 3.0 mg weeks 9-12); 4.5 mg cohort (1.5 mg weeks 1-4; 3.0 mg weeks 5-8; 4.5 mg weeks 9-12); 6.0 mg cohort (2.0 mg weeks 1-4; 4.0 mg weeks 5-8; 6.0 mg weeks 9-12). The participants, investigators and study site personnel involved in treating and assessing participants within each cohort were masked to treatment allocation. The primary endpoints were safety and tolerability of IBI362. This study is registered with ClinicalTrials.gov, number NCT04440345.

FINDINGS:

Between June 15^th, 2020 and January 15^th, 2021, 12 participants were enrolled and randomised in each cohort. Throughout the study, no participant discontinued the treatment due to safety reason and no serious adverse event was reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events and mostly mild in severity. Three participants receiving IBI362 reported mild and asymptomatic cardiac disorders revealed by electrocardiogram. Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.

INTERPRETATION:

IBI362 was well tolerated and showed a body weight-lowering effect in Chinese adults with overweight or obesity.

FUNDING:

Innovent Biologics.

505

项与玛仕度肽相关的新闻（医药）

2024-09-05

·阿基米德Biotech

不出海，毋宁死

生个穷儿子叫富贵，养条土狗叫旺财，好彩头在物资匮乏年代传递着美好憧憬。老百姓，万事利，家家悦，欢乐家，安居宝，生意宝，人民同泰……好彩头概念今日集体涨停，在增量匮乏年代也传递着美好憧憬。愿我们都有美好的未来。 8月PMI为49.1%，比上月下降0.3个百分点。代表内需的PMI新订单指数降，代表外需的PMI新出口订单指数升，内需弱，外需强，这与我们观察到的医药龙头海外收入增速大于国内收入增速完全一致。出海能力将是药企越来越重要的基本面。内需已经难觅增量行业。2024H1，排除产科，全国整体手术量同比增长8%，治疗刚需仍是少有的增量，但整个医药产业上中下游均面临控费压力。第十批国采和4大全国联采（中成药、中药饮片、可替代药品、肿瘤和呼吸系统用药）将在今年剩下时间内密集开展。如果以后我们还有心情驻足回望，会发现2024年中报是一个分水岭，中药企业弱周期金身已破，内需+消费逻辑开始瓦解，而Biotech开始转向以国际化逻辑为主导。 01 中药也不是避风港医药有一个特殊规律，每当感冒发烧药物需求旺盛时，中药都成为最大赢家。据华福证券，2024H1，中药板块（71家中药上市公司）营收1850.3亿元，同比下降2.8%，归母净利润216.1亿元，同比下降5.6%。一种为中药挽尊的说法是去年同期感冒药大卖造成业绩基数较高，但中药板块2024Q2营收864亿元，环比下降12.4%，归母净利润90.4亿元，环比下降28.1%，雷声隐隐。 2024Q2净利润增速保持20%以上的中药企业有羚锐制药、华润三九、佐力药业、贵州三力、方盛制药、马应龙、东阿阿胶，但大部分主流中药企业都严重降速。中药老大片仔癀，2024Q2营收同比增长2.65%，净利润同比下降3.13%，存货45.4亿元，比今年初增加34%，在消费下行趋势中提价权丧失，今后业绩压力会更大。风光不再，霜降已至，2024Q2营收、净利润双降的中药企业有同仁堂、达仁堂、济川药业、以岭药业、步长制药、葵花药业、太极集团、康恩贝、康缘药业、仁和药业、健民集团、寿仙谷。2024Q2营收或净利润单降的中药企业有云南白药、天士力、江中药业、昆药集团、广誉远。据浙商证券统计，受上游中药材涨价、高端消费不景气、药店客流量下滑、中药集采动态联动、医药商业回款压力大的影响，2024Q2，71家申万中药企业中有23家取得毛利润正增长，个数创2021年以来新低。困在内需中，对消费能力萎缩、控费压力变大难以抵挡。院外大单品逻辑承压。多地出台院外和零售终端价格治理政策，上线比价系统不仅伤及零售药店，还殃及中药池鱼，部分中药企业核心产品OTC渠道收入占比较高，面临降价压力。院内集采逐步扩展至全国层面。至今已开展4次规模较大涉及中药的省际联盟集采，今年下半年还有两次中药全国联采。相比九批国采化药平均降幅53%，历次中药集采平均降幅范围为23%-56%，相对温和，但仍会影响业绩。济川药业核心产品雷贝拉唑（2023年收入超9亿元）2024年3月执行第九批国采，降价显著影响Q2业绩。江中药业2024H1处方药类产品收入同比下滑27.79%，毛利率49.62%，同比下降22.03pp，主要由于部分产品集采未中标引起产品结构变化、整体收入规模下降，导致毛利率下降。 2021年全球前 25 名畅销药品在主要国家的相对价格水平 02 Biotech估值由海外定价康方生物卡度尼利单抗(PD-1/CTLA-4双抗)，2024H1销售额7.06亿元，环比下滑6%，但市场选择无视，国内市场已经不重要，反而是9月8日WCLC会议口头报告依沃西单抗(PD-1/VEGF双抗)HARMONi-2数据引起广泛关注。百济神州、康方生物、亚盛医药、和黄医药、传奇生物、科伦博泰估值逻辑都以海外市场定价为主，这有望成为创新药行业的趋势。信达生物是例外，依靠国内市场即可上岸。但这种路径难以复制，没人比他更卷，信达生物不愧是效率之王，氟泽雷塞片获批上市，系国内首个获批KRASG12C抑制剂，后来居上，做内需就要卷到极致。解决生存问题之后，打开成长天花板依然要靠国际化。信达生物自研品种PD-1/IL-2在IO失败肿瘤及冷肿瘤已有初步积极信号，启动美国II期临床，CLDN18.2ADC为首个在PDAC中看到积极信号的ADC，新一代TCE双抗CLDN18.2/CD3在GC和PDAC看到积极信号。至此，信达生物补齐自研短板，不再有明显缺点，只等减肥药玛仕度肽获批。创新药在国内市场承担社会效益、公益责任。据银河证券，按照2021年全球前25名畅销药品的销售数据，假设美国药价水平为100%，英国、欧盟和日本的平均药价约为美国20%-25%，而我国创新药价格体系定价水平处于相对较低位置，平均药价仅为美国10%。创新药受益于国内市场的正外部性，包括工程师红利、临床资源优势。考虑到支付环境差异，美中药物经济学合理换算比例可能约为1/7，而实际低至1/10，其间的差价即为创新药企对国内市场正外部性做出的补贴。创新药出海当前以License out为主（占比78%），自主出海（占比4%）、合作开发（占比18%）为辅。中国创新药License out 在 2024H1有32个项目成功签订，涉及交易金额超200亿美元，同比增长15%。 License out又以获取首付款为主，成为一二级市场Biotech输血的主要来源，也成为传统药企增厚业绩的新武器。恒瑞医药2024H1净利润34.32亿元，为历年中报最高，受益于Merck 1.6亿欧元首付款，考虑到恒瑞医药优质管线众多及BD能力精进，BD首付款应该是常态化收入（美国Hercules 公司首付款和近期里程碑款总计1.1亿美元将在2024H2确认）。 License out进阶是里程碑付款和销售分成的兑现，科伦博泰SKB264（TROP2 ADC）、亚盛医药耐立克（第三代BCR-ABL抑制剂）、乐普生物/康诺亚CMG901（Cluadin18.2 ADC）均具有这方面的潜力。复盘小野制药10年国际化经历，可见大品种License out带来的时间复利。小野制药与BMS协定，O药获批上市后，小野制药根据产品销售收入获取一定比例的销售分成（北美地区为4%，其他地区为15%）。根据与默沙东的专利纠纷和解协议，K药也对小野制药进行一定比例分成。 2014财年至2023财年，小野制药收入从1358亿日元增长到5027亿日元，年复合增速为15.66%，来自MNC的销售分成也逐年增长，2023财年公司从BMS和Merck获得的分成收入分别为979亿日元和530亿日元，占公司当年收入比例分别为19.47%和10.54%。左图：小野制药近年来收入拆分（单位：十亿日元）右图：小野制药近年来从BMS和Merck获取分成收入情况（单位：十亿日元） 03 制造业海外加速扩表参考日本失去三十年，还有一种国际化通路，制造企业在海外积极布局产业链。据民生证券，1996年至2022年，日本对外投资规模翻了8倍，日本对外投资规模存量已占日本2022年GDP的比重近50%；2021年日本海外净资产规模占GDP比重约为75%，较1996年增长3倍；1997财年日本海外子公司营业收入占总公司收入比重为37.5%，截至2020财年，海外子公司营业收入已达到总公司营业收入的69.3%，占比近乎翻倍。出海投资让日本企业在海外扩张资产负债表，海外扩表有效对冲国内缩表，最终使日本在“失去的三十年”过程中依然保持令人惊讶的总量经济平衡与社会稳定。 CDMO作为中国创新药产业链中枢，已经率先走向海外生产型投资，可适当对冲地缘风险。药明康德中报未现明显脱钩迹象，截至今年6月底在手订单431亿元，相比去年底增加23%。全球前20大制药企业客户收入65.9亿元，剔除新冠商业化项目同比增长11.9%。来自美国客户收入107.1亿元，剔除特定商业化生产项目同比下降1.2%；来自欧洲客户收入22.2亿元，同比增长5.3%；来自中国客户收入34.0亿元，同比增长2.8%。推进全球各项产能建设，预计资本开支~50亿元，2024年5月，新加坡研发及生产基地正式开工建设，美国特拉华州生产基地项目预算37.56亿元，工程进度32%。药明生物2024H1北美收入占比升至58.4%（上年同期为46.3%），中国收入占比降至16.6%（上年同期为21.1%），内需不可靠，还得靠国际化。新加坡CRDMO一体化服务中心正式进入建设阶段，规划产能为12万升，预计2026年投入运营；爱尔兰基地商业化生产需求增加，2025年排产已经接近订满，预计2026年进入稳定运营阶段，MFG6.1在2024上半年成功完成首次工艺验证（PPQ），MFG7已启动商业化生产；美国克兰伯里基地已完成9批GMP原液生产、3批原液试生产和7个细胞库。凯莱英2024H1新签订单同比增长超过20%，且Q2较Q1环比有较大幅度增长，其中来自于欧美市场客户订单增速超过公司整体订单增速水平。截至中报披露日，在手订单总额9.7亿美元（今年3月底在手订单总额8.74亿美元）。接管辉瑞英国Sandwich工厂并于8月初正式投入运营，预计9月开始有订单，全球供应链体系逐渐完善，主要满足临床前到临床后期项目承接，为未来欧洲商业化产能基地布局带来CMC工艺支撑。康龙化成2024H1新签订单同比增长超过15%，连续2个季度实现温和复苏。在英国和美国共有11个运营实体，超过1700名员工，2024H1，海外子公司交付收入73683.36万元，同比增长3.99%，占营业收入13.15%。药明生物2024H1后期及商业化生产项目减少3个，反映出三星生物抢单的压力。三星生物拟推出安进重磅骨科药物普罗力（Prolia）和安加维（Xgeva）的生物类似物版本，被安进起诉侵权。这警示跨国药企，不能让单一CDMO过于强大，以致于不受控制，需要在地缘之间均衡分配产能。继CXO之后，相信有更多创新药械企业走出去，在海外实施扩表。

财报

2024-09-02

·PRNewswire

Innovent Annouces Multiple Clinical Study Results of Mazdutide to be Presented at the EASD 2024

SAN FRANCISCO and SUZHOU, China, Sept. 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that multiple clinical study results of mazdutide (GLP-1R/GCGR dual agonist) will be presented at the European Association for the Study of Diabetes® (EASD) 60th Annual Meeting in Madrid, Spain from September 9 -13, 2024. New data of mazdutide at EASD include the results from the Phase 3 study of mazdutide in Chinese adults with type 2 diabetes (DREAMS-2) in late-breaking oral presentation. Details are listed below： Title: Mazdutide vs Dulaglutide in Patients with Type 2 Diabetes (DREAMS-2): a Randomized, Open-label, 28-week Phase 3 Trial Abstract #：LBA 16 Presentation Form：LBA Oral Presentation Time：September 11th, 4:15 PM-4:30 PM (CEST) Presenter：Prof. Lixin Guo, Peking Hospital Title: Efficacy and Safety of Mazdutide in Chinese Participants with Overweight or Obesity (GLORY-1) Abstract #：149 Presentation Form：Oral presentation Time：September 12th, 11:45 AM-12:00 PM (CEST) Presenter：Prof. Linong Ji, Peking University People's Hospital Title: Improvement of Liver Steatosis by Mazdutide in Chinese Participants with Overweight or Obesity—An Exploratory Analysis of GLORY-1 Abstract #：744 Presentation Form：Short Oral Presentation Time：September 10th, 12:30 PM (CEST) Presenter：Prof. Leili Gao Peking University People's Hospital Title: A Phase 2 Study of Mazdutide 9 mg in Chinese Adults with BMI≥30 kg/m2 Abstract #：733 Presentation Form：Short Oral Presentation Time：September 12th, 2:00 PM (CEST) Presenter：Prof. Hongwei Jiang, the First Affiliated Hospital of Henan University of Science and Technology Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are delighted that the results of the Phase 3 study DREAMS-2 for mazdutide in T2D will be presented in the form of a late-breaking oral presentation at the EASD annual meeting. Mazdutide is the first GLP-1R/GCGR dual agonist to successfully complete a Phase 3 study for diabetes, demonstrating superior blood sugar-lowering and weight loss efficacy compared to dulaglutide. Of equal importance, a number of weight loss study data of mazdutide, including the GLORY-1 Phase 3 study, the 9 mg Phase 2 study will also be showcased at this EASD conference. The weight loss and glucose lowering efficacy and metabolic benefits of mazdutide, especially in the liver, have been consistently observed and further validated across clinical trials and patient populations." 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 promotes insulin secretion, lowers blood glucose and reduces body weight similar to GLP-1 receptor agonists. Additionally, it may increase energy expenditure and improve hepatic fat metabolism by activating the glucagon receptor. Mazdutide has strong efficacy in weight loss and lowering glucose levels in clinical studies. It also offers multiple cardio-metabolic benefits, such as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, while improving insulin sensitivity. Mazdutide has two NDAs accepted by China's NMPA for review, including: For the chronic weight management in adults with obesity or overweight; For the glycemic control in adults with type 2 diabetes. Currently, a total of five Phase 3 studies of mazdutide are underway, including: Phase 3 study conducted in Chinese adults with overweight or obesity (GLORY-1); Phase 3 study conducted in Chinese adults with moderate to severe obesity (GLORY-2); Phase 3 study in newly treated Chinese patients with type 2 diabetes (DREAMS-1); Phase 3 study comparing mazdutide and dulaglutide in Chinese patients with type 2 diabetes (DREAMS-2); Phase 3 study comparing mazdutide and semaglutide in Chinese patients with type 2 diabetes and obesity (DREAMS-3). Among them, GLORY-1, DREAMS-1 and DREAMS-2 have reached the study endpoints and successfully completed. About 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 has 11 products in the market, 3 new drug applications under the NMPA review, 4 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. 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 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. 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. 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 materialize or is otherwise inaccurate. SOURCE Innovent Biologics

临床2期临床3期引进/卖出

2024-09-02

·信达生物

玛仕度肽的多项临床研究数据将于第60届欧洲糖尿病研究学会（EASD）年会报告

2024年9月2日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司宣布，玛仕度肽的多项临床研究数据将在第60届欧洲糖尿病研究学会（EASD）年会上口头报告，最新数据包括玛仕度肽2型糖尿病III期注册临床研究DREAMS-2的结果将以重磅进展（LBA）口头报告。本次大会将于2024年9月9日-13日在西班牙马德里召开。具体信息如下：标题：一项在2型糖尿病患者中对比玛仕度肽与度拉糖肽的28周III期随机、开放标签试验（DREAMS-2）结果摘要编号：LBA 16 展示形式：重磅进展口头报告时间：9月11日下午16:15 -16:30 (当地时间) 演讲者：郭立新教授北京医院标题：一项玛仕度肽在中国超重或肥胖人群中的III期研究 (GLORY-1) 结果摘要编号：149 展示形式：口头报告时间：9月12日上午11:45 -12:00 (当地时间) 演讲者：纪立农教授北京大学人民医院标题：玛仕度肽改善中国超重或肥胖受试者肝脂肪变形：GLORY-1研究的探索性分析摘要编号：744 展示形式：简短口头报告时间：9月10日下午12:30 (当地时间) 演讲者：高蕾莉教授北京大学人民医院标题：玛仕度肽9mg在BMI≥30 kg/m2的中国成人受试者中的II期研究摘要编号：733 展示形式：简短口头报告时间：9月12日下午14:00 (当地时间) 演讲者：姜宏卫教授河南科技大学第一附属医院信达生物制药集团临床开发副总裁钱镭博士表示：“继今年6月ADA大会公布玛仕度肽首个减重III期GLORY-1研究的结果后，我们很高兴玛仕度肽的糖尿病III期DREAMS-2研究的结果将在EASD大会以重磅进展口头报告的形式首次公布。玛仕度肽是目前全球唯一开展糖尿病III期研究的GLP-1和GCG受体双重激动剂，DREAMS-2研究证明了其优于度拉糖肽的降糖和减重疗效。同时，包括GLORY-1研究、玛仕度肽9 mg II期研究在内的多项减重研究数据还将以口头报告或简短口头报告的形式在此次EASD大会展示。玛仕度肽的降糖、减重疗效和肝脏脂肪降低及其他综合代谢获益在不断的临床探索中得以反复证明和拓展。” 关于玛仕度肽（IBI362） - 滑动查看更多介绍 - 玛仕度肽（IBI362）是信达生物与礼来制药共同推进的一款胰高血糖素样肽-1受体（GLP-1R）/胰高血糖素受体（GCGR）双重激动剂。作为一种人体内天然存在的胃泌酸调节素（OXM）类似物，玛仕度肽除了通过激动GLP-1R促进胰岛素分泌、降低血糖和减轻体重外，还可通过激动GCGR增加能量消耗增强减重疗效，同时改善肝脏脂肪代谢。玛仕度肽已在多项临床研究中展现出优秀的减重和降糖疗效，以及降低腰围、血脂、血压、血尿酸、肝酶及肝脏脂肪含量，以及改善胰岛素敏感性，带来多重代谢获益。玛仕度肽当前共有两项NDA获NMPA受理审评，包括：用于成人肥胖或超重患者的长期体重控制；用于成人2型糖尿病患者的血糖控制。玛仕度肽当前共开展了五项III期临床研究，包括：在中国超重或肥胖受试者中开展的III期临床研究（GLORY-1）；在中重度肥胖的中国肥胖受试者中开展的III期临床研究（GLORY-2）；在初治的中国2型糖尿病患者中开展的III期临床研究（DREAMS-1）；在口服药物治疗血糖控制不佳的中国2型糖尿病受试者中开展的对比玛仕度肽和度拉糖肽的III期临床研究（DREAMS-2）；在中国2型糖尿病合并肥胖的受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（DREAMS-3）。其中，GLORY-1、DREAMS-1和DREAMS-2研究均已达成终点并顺利完成。关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有11个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®）和氟泽雷塞片（达伯特®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。声明： 1.信达生物不推荐未获批的药品/适应症的使用 2.雷莫西尤单抗注射液（希冉择®）和塞普替尼胶囊（睿妥®）由礼来公司研发前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床3期临床2期临床成功申请上市临床结果

100 项与玛仕度肽相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	申请上市	中国	信达生物制药（苏州）有限公司	2024-08-01
肥胖	申请上市	中国	信达生物制药（苏州）有限公司	2024-02-07
超重	申请上市	中国	信达生物制药（苏州）有限公司	2024-02-07
早发性 II 型糖尿病	临床3期	中国	信达生物制药（苏州）有限公司	2024-02-29
肾功能不全	临床1期	中国	Innovent Biologics (HK) Ltd.	2023-05-05
MASH	临床申请批准	中国	信达生物制药（苏州）有限公司	2023-03-22
高尿酸血症	临床前	中国	信达生物制药（苏州）有限公司	2023-07-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05628311 (DREAMS-1, PRNewswire) 人工标引	临床3期	2型糖尿病	-	Mazdutide 4 mg	鹽餘簾醖窪構構淵願蓋(積鑰簾淵鏇製艱艱醖顧) = 選構鹹壓醖餘鹹簾獵鑰襯醖夢醖願構夢鑰網襯 (蓋鬱壓獵鏇簾廠膚獵艱 ) 达到	积极	2024-07-21
				Mazdutide 6 mg	鹽餘簾醖窪構構淵願蓋(積鑰簾淵鏇製艱艱醖顧) = 壓簾鑰壓積艱衊齋繭壓襯醖夢醖願構夢鑰網襯 (蓋鬱壓獵鏇簾廠膚獵艱 ) 达到
NCT05607680 (GLORY-1, ADA2024) 人工标引	临床3期	超重 \| 肥胖	69	Mazdutide 4mg	夢淵範網憲網遞齋鏇選(網製獵壓顧顧廠製齋網) = 選醖壓壓鏇齋鹽觸範觸繭觸築淵遞願廠製遞餘 (構蓋壓鬱築構積憲餘簾 ) 更多	积极	2024-06-21
				Mazdutide 6mg	夢淵範網憲網遞齋鏇選(網製獵壓顧顧廠製齋網) = 憲選選積願觸鹹廠鏇膚繭觸築淵遞願廠製遞餘 (構蓋壓鬱築構積憲餘簾 ) 更多
NCT04904913 (ADA2024) 人工标引	临床2期	肥胖	80	Mazdutide	簾遞願窪顧淵顧鬱範壓(鹹艱膚鹽夢廠積築選淵) = 獵襯壓夢獵糧齋蓋膚壓夢淵顧鬱觸簾積鑰鏇顧 (艱製繭憲構襯選衊鹽觸 ) 更多	积极	2024-06-20
				Placebo	簾遞願窪顧淵顧鬱範壓(鹹艱膚鹽夢廠積築選淵) = 鹽艱襯夢製製觸艱壓遞夢淵顧鬱觸簾積鑰鏇顧 (艱製繭憲構襯選衊鹽觸 ) 更多
NCT05607680 (GLORY-1, ADA2024) 人工标引	临床3期	超重 \| 肥胖	610	mazdutide 4 mg	選壓糧淵蓋構簾簾遞網(簾壓製製餘齋簾鹽衊襯) = 淵鏇艱窪蓋範蓋願衊製夢積網鹹製夢艱製鑰鹹 (鏇網膚鬱齋遞願積衊壓, 0.538) 达到更多	积极	2024-06-14
				mazdutide 6 mg	選壓糧淵蓋構簾簾遞網(簾壓製製餘齋簾鹽衊襯) = 齋壓醖醖觸築積廠醖觸夢積網鹹製夢艱製鑰鹹 (鏇網膚鬱齋遞願積衊壓, 0.558) 达到更多
NCT05606913 (DREAMS-2, Corporate Publications) 人工标引	临床3期	2型糖尿病	731	mazdutide 4.0 mg	簾顧製醖鹹蓋觸積顧糧(觸積顧壓衊窪襯繭廠鬱) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. 鬱鬱壓衊餘鑰糧夢鬱製 (鹽製膚積顧齋積餘夢憲 ) 达到更多	优效	2024-05-09
				mazdutide 6.0 mg
NCT05607680 (GLORY-1, Corporate Publications) 人工标引	临床3期	超重 \| 肥胖	610	玛仕度肽 4 mg	膚衊鹽襯顧衊淵鑰蓋廠(夢簾壓襯壓淵壓範顧築) = 主要研究终点顺利达成：玛仕度肽 4 mg和6 mg组受试者治疗32周后体重相对基线的百分比变化显著优于安慰剂组觸簾淵艱鬱糧繭糧壓顧 (廠鬱遞築鹹淵醖壓選衊 ) 达到更多	积极	2024-01-09
				玛仕度肽 6 mg
NCT04904913 (Pubmed) 人工标引	临床2期	超重 \| 肥胖	248	Mazdutide 3 mg	製衊鹽鑰網遞網鹹艱築(齋淵鏇蓋衊顧餘鹽遞選) = 廠簾淵願醖築衊選網餘積夢淵鑰衊遞繭憲鹹顧 (構製醖膚糧醖襯選觸糧, 0.7)	积极	2023-12-14
				Mazdutide 4.5 mg	製衊鹽鑰網遞網鹹艱築(齋淵鏇蓋衊顧餘鹽遞選) = 繭築鹽齋廠廠醖糧觸襯積夢淵鑰衊遞繭憲鹹顧 (構製醖膚糧醖襯選觸糧, 0.7)
NCT04904913 (Literature) 人工标引	临床2期	超重 \| 肥胖	248	mazdutide 3 mg	選簾醖願網鏇壓鹽積衊(繭選願艱醖遞窪遞膚鬱) = 積獵選夢醖衊鑰鏇鑰積鏇壓襯遞齋築鹹淵餘淵 (鏇獵淵遞構窪獵顧夢夢, 0.7) 更多	积极	2023-12-14
				mazdutide 4.5 mg	選簾醖願網鏇壓鹽積衊(繭選願艱醖遞窪遞膚鬱) = 窪獵糧襯餘窪衊築鏇鬱鏇壓襯遞齋築鹹淵餘淵 (鏇獵淵遞構窪獵顧夢夢, 0.7) 更多
NCT04965506 (Literature) 人工标引	临床2期	2型糖尿病	250	Mazdutide 3 mg	鏇夢鹹鬱選製顧襯廠構(願壓鬱築觸鑰觸鏇膚獵) = 艱襯襯獵構鹽範製選繭鏇衊鏇膚淵淵壓齋糧襯 (簾製膚範糧觸窪糧範構 ) 更多	积极	2023-11-09
				Mazdutide 4.5 mg	鏇夢鹹鬱選製顧襯廠構(願壓鬱築觸鑰觸鏇膚獵) = 襯廠淵築網鏇衊憲觸鏇鏇衊鏇膚淵淵壓齋糧襯 (簾製膚範糧觸窪糧範構 ) 更多
NCT04904913 (PRNewswire) 人工标引	临床2期	肥胖	80	Mazdutide 9 mg	夢襯鏇範鹽顧醖網膚願(製糧繭構襯襯網廠範鏇): Difference(%) = -15.4 达到更多	积极	2023-10-30
				placebo