This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study

开始日期2025-06-17

申办/合作机构

信达生物制药（苏州）有限公司

NCT06931028

/ Recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg/m2 (GLORY-OSA)

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

开始日期2025-06-12

申办/合作机构

信达生物制药（苏州）有限公司

NCT06937749

/ Not yet recruiting临床2期

A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.

开始日期2025-05-30

申办/合作机构

信达生物制药（苏州）有限公司

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）

2025-07-01·EBioMedicine

Mazdutide, a dual agonist targeting GLP-1R and GCGR, mitigates diabetes-associated cognitive dysfunction: mechanistic insights from multi-omics analysis

Article

作者: Yang, Maoxing ; Zhao, Ziyue ; Dong, Wanqing ; Zhang, Yongjiang ; Zhang, Ziyue ; Jiang, Hongwei ; Bai, Jie ; Yuan, Qibin ; Zhang, Yingyu ; Li, Hanxiao

BACKGROUND:

Cognitive impairment and dementia are highly associated with obesity and type 2 diabetes mellitus (T2DM). Recent studies have demonstrated that GLP-1 receptor agonists can improve cognitive function through brain activation in patients with T2DM, compared to other oral glucose-lowering drugs. Mazdutide, a dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has been shown to simultaneously reduce body weight, blood glucose levels, and other comorbidities associated with obesity in patients with T2DM. While its insulinotropic and glucose-lowering effects through the GLP-1 pathway are well-established, mazdutide may also enhance energy expenditure via activation of the GCGR pathway. However, its potential impact on cognitive function remains to be elucidated.

METHODS:

This study aimed to investigate the effects of mazdutide on cognitive behaviour and cerebral pathology in male db/db mice, a model of T2DM, in comparison to dulaglutide, a GLP-1 receptor agonist. All animal findings are applicable to male mice only. Behavioural tests were conducted to evaluate cognitive function, and pathological analyses were performed to assess neurodegenerative markers in the brain. Furthermore, transcriptomic, proteomic, and metabolomics analyses were employed to explore the underlying molecular mechanisms of mazdutide's effects.

FINDINGS:

Compared to dulaglutide, mazdutide significantly improved cognitive performance in db/db mice, as evidenced by comprehensive behavioural tests. Pathological assessments revealed improvements in neuronal structure and brain tissue integrity in the mazdutide-treated group. Multi-omics analyses further identified distinct molecular pathways involved in neuroprotection, energy metabolism, and synaptic plasticity, suggesting that dual GLP-1/GCGR activation contributes to enhanced cognitive resilience.

INTERPRETATION:

Our findings indicate that mazdutide, via its dual GLP-1/GCGR activation effects, exerts multifactorial improvements in cognitive function in the context of obesity and T2DM. These results suggest that mazdutide is a promising therapeutic option for mitigating cognitive deficits associated with metabolic disorders.

FUNDING:

Medical Science and Technology Research and Development Plan Major Project Jointly Constructed by the Henan Province and Ministerial Departments in China (No. SBGJ202301010).

2025-06-12·NEW ENGLAND JOURNAL OF MEDICINE

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight

Article

作者: Wang, Yanqi ; Tian, Junhang ; Deng, Huan ; Liu, Zihan ; Lv, Lingchun ; Ji, Linong ; Liu, Dexue ; Li, Li ; Gu, Jieyu ; Qian, Lei ; Lian, Qiufang ; Yang, Ping ; Chen, Lei ; Huang, Chongbing ; Zhong, Shao ; Qiu, Wei ; Li, Hua ; Bi, Yan ; Jiang, Hongwei ; Han, Jie ; Pei, Lijuan ; Zhao, Yuzhu ; Zhang, Yawei

BACKGROUND:

Evidence suggests that incretin-based dual agonist pharmacotherapy is helpful in persons with obesity. Mazdutide, a glucagon-like peptide-1 and glucagon receptor dual agonist, may have efficacy in persons with overweight or obesity.

METHODS:

In a phase 3, double-blind, placebo-controlled trial in China, we randomly assigned, in a 1:1:1 ratio, adults 18 to 75 years of age who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 28 or had a BMI of 24 to less than 28 plus at least one weight-related coexisting condition to receive 4 mg of mazdutide, 6 mg of mazdutide, or placebo for 48 weeks. The two primary end points were the percentage change in body weight from baseline and a weight reduction of at least 5% at week 32, as assessed in a treatment-policy estimand analysis (which assessed effects regardless of early discontinuation of mazdutide or placebo and the initiation of new antiobesity therapies).

RESULTS:

Among 610 participants, the mean body weight was 87.2 kg and the mean BMI was 31.1 at baseline. At week 32, the mean percentage change in body weight from baseline was -10.09% (95% confidence interval [CI], -11.15 to -9.04) in the 4-mg mazdutide group, -12.55% (95% CI, -13.64 to -11.45) in the 6-mg mazdutide group, and 0.45% (95% CI, -0.61 to 1.52) in the placebo group, and 73.9%, 82.0%, and 10.5% of the participants, respectively, had a weight reduction of at least 5% (P<0.001 for all comparisons with placebo). At week 48, the mean percentage change in body weight from baseline was -11.00% (95% CI, -12.27 to -9.73) in the 4-mg mazdutide group, -14.01% (95% CI, -15.36 to -12.66) in the 6-mg mazdutide group, and 0.30% (95% CI, -0.98 to 1.58) in the placebo group, and 35.7%, 49.5%, and 2.0% of the participants, respectively, had a weight reduction of at least 15% (P<0.001 for all comparisons with placebo). Beneficial effects on all prespecified cardiometabolic measures were seen with mazdutide. The most frequently reported adverse events were gastrointestinal and mostly mild to moderate in severity. The incidence of adverse events leading to discontinuation of the trial regimen was 1.5% with the 4-mg mazdutide dose, 0.5% with the 6-mg mazdutide dose, and 1.0% with placebo.

CONCLUSIONS:

In Chinese adults with overweight or obesity, once-weekly mazdutide at a dose of 4 mg or 6 mg for 32 weeks led to clinically relevant reductions in body weight. (Funded by Innovent Biologics; GLORY-1 ClinicalTrials.gov number, NCT05607680.).

2025-05-01·PEPTIDES

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities

Review

作者: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

Recent studies with peptide-based incretin therapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Randomised clinical trials and 'real-world' studies have confirmed the marked glucose-lowering and weight-lowering efficacy of these agents across diverse populations. These include different ethnic groups, young and elderly individuals with and without diabetes and/or overweight or obesity. Recent studies have also confirmed protections against the development and progression of cardiovascular and renal diseases that are additive to the benefits conferred by improved control of blood glucose and body weight. Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline. New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).

623

项与玛仕度肽相关的新闻（医药）

2025-07-13

·精准药物

2025年上半年NMPA批准创新药54个！列表一览

2025年上半年，CDE共受理6213个品种，同比增长15.83%，化药仍为主体，达4087个品种；中药818个品种；生物制品1305个品种。完成审评5848个品种，同比增长9.49%；共计批准创新药上市54个品种（根据药智数据企业版——药品注册与受理数据库统计，品种根据药品+企业维度统计）。审评情况2025年上半年，CDE已完成审批品种共计5848个（受理号8210个），同比增长9.49%，申请类型为新药、进口、仿制的药品注册申请共计2847个品种（受理号4029个）。化药完成审评3738个品种，占审评总量的65.75%；中药完成审评1314个品种，同比增长18.49%；生物制品完成审评790个品种，同比增长16.01%。按注册分类统计，1类创新药完成审评804个品种，其中IND完成审评746个品种，批准临床率约为95%；NDA完成审评61个品种，批准上市率约为89%。2类改良型新药完成审评239个品种，其中IND完成审评196个品种，批准临床率约为92%；NDA完成审评47个品种，批准上市率约为96%。针对已获批的1类创新药名单进行详细分析，从适应症来看，抗肿瘤药和免疫机能调节药获批最多，占据获批总量的40.74%，以乳腺癌、非小细胞肺癌等为主；其次是消化道及代谢，占14.81%，包含2型糖尿病、预防化疗引起的呕吐等。剂型方面，以片剂、注射液为主，片剂18个品种，注射液15个品种，粉针10个品种。获批省份来看，以沿海地区为主，江苏、上海、广东占据前三，与2024年排名一致。从获批企业来看，恒瑞医药表现亮眼，按集团计已有10款新药上市；其次是凯莱英医药集团，有3款新药上市。整体来看，在这54个新药品种中，抗肿瘤药物以22款的数量成为当之无愧的第一大治疗领域。乳腺癌获批药物众多，有国产新药有轩竹生物的吡洛西利片、锦州奥鸿药业的枸橼酸伏维西利胶囊、贝达药业的酒石酸泰瑞西利胶囊，进口新药有Roche的伊那利塞片、AstraZeneca的卡匹色替片以及Genor Biopharma的盐酸来罗西利片。其余如四川科伦博泰的塔戈利单抗注射液（鼻咽癌）、江苏恒瑞的苹果酸法米替尼胶囊（宫颈癌）、百济神州的注射用泽尼达妥单抗（胆道癌）等实体瘤也迎来多款创新药物。除肿瘤领域，铂生卓越的艾米迈托赛注射液获NMPA附条件批准上市，用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病，成为国内首个获批上市的干细胞疗法。信达生物研发的首个GCG/GLP-1双受体激动减重药物——玛仕度肽注射液，其临床研究表明，使用玛仕度肽体重降幅达21%，降低肝脏脂肪含量超80%，腰围减少达11cm，颈围减少达3cm，兼顾改善血糖、血压、血脂、血尿酸和转氨酶水平等心血管及代谢指标，实现体重与代谢指标双改善。海思科的安瑞克芬注射液作为国内首批获得镇痛适应证的高选择性外周k受体激动剂，开启术后镇痛新时代。表1 2025年1~6月创新药上市申请审评结论情况注：数据统计至2025年7月9日声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

上市批准临床申请申请上市

2025-07-11

·戊戌数据

【注册报告】2025年6月药品注册审评审批报告

2025年6月药品受理情况1.2025年6月受理总况2025年6月，国家药品监督管理局药品审评中心（以下称药审中心）共计受理1382个受理号，比去年同期增加10%。图一 2024和2025年药审中心药品受理情况受理的药品中，化药占比62%，生物制品18%，中药20%，还有一项体外诊断试剂未计入下图。图二 2025年6月各药品类型受理情况2.化药受理情况2025年6月化药受理总数为855个。图三 2025年6月化药各申请类型受理情况化药1类创新药申报共计105个受理号，包含国产和进口品种。图四 2025年6月化药各注册分类受理情况备注：注册分类统计只包含新药、进口、仿制药。本月新申报的1类化药共计23个品种，涉及21个企业。表1 6月首次申报临床的化药创新药本月共有3个1类新药首次提交了上市申请。硫酸索美来昔片索美来昔（JMKX001899）是一款KRAS G12C抑制剂。JMKX001899 在大中华区以外的开发、生产及商业化权利独家许可已授权给沪亚生物国际。2025年6月，硫酸索美来昔片上市申请获得NMPA受理，用于至少接受过一种系统性治疗的 KRAS G12C 突变型的晚期非小细胞肺癌（NSCLC）成人患者。盐酸匹米替尼胶囊ABSK-021是和誉医药自主研发的一款口服CSF-1R小分子抑制剂。研究表明，阻断CSF-1R信号通路可调节和改变肿瘤微环境，解除肿瘤免疫抑制，能够与肿瘤免疫检查点抗体等多种抗癌疗法产生协同作用，达到良好的抑瘤功能。多项临床研究已经证实，抑制CSF-1R活性可用于治疗腱鞘巨细胞瘤（TGCT）或与肿瘤免疫及其它药物联用治疗多种恶性肿瘤。2019年8月，ABSK-021获得美国FDA临床试验批准，成为和誉医药首个进入临床研究的候选药物。2023年12月4日，和誉医药宣布，已与默克公司就其自主研发的CSF-1R小分子抑制剂Pimicotinib（ABSK021）达成独家许可协议。根据协议条款，默克将获得在中国内地、中国台湾、中国香港和中国澳门针对Pimicotinib就所有适应症进行商业化的许可，和誉医药将保留在授权区域内独家开发Pimicotinib的权利。2025年6月，默克在国内递交了盐酸匹米替尼胶囊 (ABSK021) 的上市申请，并获得受理，用于需要系统性治疗的腱鞘巨细胞瘤（TGCT）成人患者。伊托法替布软膏MH004是明慧医药自主研发的一款全球首创的外用JAK抑制剂。2023年7月，MH004乳膏获国家药监局临床许可，拟开发用于治疗非节段型白癜风。2024年6月，MH004软膏获国家药监局临床许可，拟开发用于特应性皮炎患者的治疗。2025年6月，明慧医药外用JAK抑制剂伊托法替布软膏（MH004）的上市申请获NMPA受理。3.生物制品受理情况2025年6月生物制品共计受理249个，治疗用生物制品239个，预防用生物制品10个。本月生物类创新药共计24家企业新申报了26个1类生物药（表2）。表2 6月新注册临床的治疗用生物创新药表3 6月新申报上市的生物类似药本月有3项1类治疗用生物制品申报上市。重组抗IL-1β人源化单克隆抗体注射液2025年6月，三生国健宣布，公司自主创新研发的重组抗IL-1β人源化单克隆抗体注射液SSGJ-613急性痛风性关节炎适应症已向国家药品监督管理局递交上市申请并获受理。Clesrovimab注射液Clesrovimab（MK-1654）是由默沙东研发的一种抗RSV F蛋白的全人源单克隆抗体。2025年4月，Merck Sharp & Dohme B.V的1类创新药Clesrovimab注射液在中国首次申请上市。6月，重新提交了新药上市申请。舒瑞基奥仑赛注射液CT-041是由科济生物开发，针对CLDN18.2靶向的CAR-T细胞疗法，用于治疗CLDN18.2阳性实体肿瘤患者，主要治疗胃癌/胃食管结合部癌及胰腺癌。2025年6月，舒瑞基奥仑赛注射液（CT041）的新药上市申请（NDA）已正式提交至中国国家药品监督管理局（NMPA）药品审评中心（CDE），用于治疗Claudin18.2表达阳性、至少二线治疗失败的晚期胃/食管胃结合部腺癌（G/GEJA）患者。4.中药受理情况本月，中药受理277个受理号，其中补充申请259个，6个1.1类新药临床试验申请，2个2.3类新药临床试验申请，1个1.1类新药上市申请，1个3.1类新药上市申请，2个4类仿制药上市申请。1.1中药复方制剂，系指由多味饮片、提取物等在中医药理论指导下组方而成的制剂。3.1按古代经典名方目录管理的中药复方制剂。表4 6月注册的中药新药及仿制药二2025年6月药品上市情况本月国家药品监督管理局新批准上市药品共计416个（以批准文号计，包含新药、进口、仿制药），其中包含化药仿制药385个，新药26个，原研进口5个。表5 6月新批准上市的创新药养血祛风止痛颗粒养血祛风止痛颗粒基于中国近代著名中医大家张锡纯先生的代表性方剂“升陷汤”的加减配方而成，能够补气养血，散风止痛。2025年6月，养血祛风止痛颗粒上市申请获得NMPA批准，功能主治：补气养血，散风止痛。用于频发性紧张型头痛中医辨证属气血两虚证，症见头痛反复发作、头脑昏沉，以及食少纳呆、自汗、气短、神疲乏力、面色苍白，舌淡苔白、脉沉细而弱等。玛仕度肽注射液2024年2月，玛仕度肽注射液NDA获NMPA受理，用于成人肥胖或超重患者的长期体重控制。2024年8月，信达生物玛仕度肽注射液的新适应症申报上市，其肥胖症上市申请已于今年2月获 CDE 受理，本次申报的新适应症为2型糖尿病。2025年6月，国家药品监督管理局批准信达生物制药（苏州）有限公司申报的1类创新药玛仕度肽注射液（商品名：信尔美)上市。该药品适用于在控制饮食和增加体力活动基础上对成人患者的长期体重控制，初始体重指数（BMI）为：BMI≥28 kg/m2（肥胖）；或BMI≥24 kg/m2（超重），并伴有至少一种体重相关的合并症（例如高血糖、高血压、血脂异常、脂肪肝、阻塞性睡眠呼吸暂停综合征等）。全氟己基辛烷滴眼液NOV03（全氟己基辛烷）是一款具有新颖作用机理的药物，用于治疗与睑板腺功能障碍（MGD）相关蒸发过强型干眼症。2019年11月，恒瑞与德国Novaliq GmbH公司达成协议，以总计1.65亿美元引进了Novaliq公司用于治疗干眼症的药物 CyclASol（0.1%环孢素A制剂）和 NOV03（全氟己基辛烷），获得这两个产品在中国的临床开发、生产和市场销售的独家权利。2022年9月，Novaliq宣布，FDA已受理其NOV03滴眼液用于治疗睑板腺功能障碍（MGD）相关干眼病的上市申请。2023年1月，江苏恒瑞医药股份有限公司子公司成都盛迪医药有限公司提交SHR8058滴眼液的药品上市许可申请获国家药监局受理，用于治疗睑板腺功能障碍相关干眼病。2023年5月，博士伦公司与Novaliq公司联合开发的全氟己基辛烷滴眼液NOV03获FDA批准上市，用于治疗干眼症的体征和症状。2025年6月，全氟己基辛烷滴眼液(恒沁®)上市，本品用于治疗睑板腺功能障碍相关干眼病。注射用盐酸伊吡诺司他BEBT-908是首创全新化学结构的PI3K/HDAC双靶点抗肿瘤 I 类新药，选择性抑制具有协同作用的核心靶点，破坏肿瘤信号通路网络，对多种血液肿瘤和实体瘤均具有很强的抗肿瘤作用。2023年10月，必贝特医药PI3K/HDAC双靶点1类新药注射用双利司他（BEBT-908）的上市申请获CDE受理，用于治疗既往至少两种系统疗法经治的复发或难治性弥漫性大B细胞淋巴瘤（r/r DLBCL）成人患者。2025年6月，国家药品监督管理局通过优先审评审批程序附条件批准广州必贝特医药股份有限公司申报的1类创新药注射用盐酸伊吡诺司他上市（商品名：贝特琳），该药品单药适用于既往接受过至少两线系统性治疗的复发或难治性弥漫性大B细胞淋巴瘤成人患者。酒石酸泰瑞西利胶囊BPI-16350是一个全新的、拥有完全自主知识产权的新分子实体化合物，由贝达药业股份有限公司研发，针对的靶点为细胞周期蛋白依赖性激酶4/6 （CDK4/6），拟单药或与激素疗法联合，主要用于治疗激素受体阳性和人类表皮生长因子受体 2 阴性(HR 阳性/HER2 阴性)的晚期或转移乳腺癌患者，还可用于 Rb+的其他癌症的一、二线或联合治疗。2024年5月，贝达药业宣布其1类新药酒石酸泰贝西利胶囊上市申请获CDE受理，针对适应症为：联合氟维司群，适用于既往接受内分泌治疗后进展的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或晚期复发转移性乳腺癌患者。2025年6月底，国家药品监督管理局批准贝达药业股份有限公司申报的1类创新药酒石酸泰瑞西利胶囊上市（商品名：康美纳），该药品联合氟维司群，适用于既往接受内分泌治疗后进展的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性成年乳腺癌患者。注射用苏维西塔单抗注射用BD0801是先声药业与美国Apexigen公司合作开发的创新药，为注射用人源化抗血管内皮细胞生长因子（抗VEGF）单克隆抗体，与贝伐珠单抗靶点一致。在分子设计上，注射用BD0801采用了更高特异性和亲和力的兔抗，可以选择性地与VEGF相结合，阻断VEGF与受体KDR和Flt-1的结合从而抑制其生物活性，进一步特异性阻止肿瘤新生血管的生成，从而抑制肿瘤的生长和转移。体外活性测试结果显示，注射用BD0801对血管内皮细胞生长因子受体2（KDR）磷酸化的抑制能力，以及对人脐静脉内皮细胞（HUVEC）细胞增殖和迁移的抑制活性强于贝伐珠单抗。2024年3月，注射用苏维西塔单抗的上市申请获NMPA受理，联合化疗治疗复发性卵巢癌、输卵管癌或原发性腹膜癌。该新药可选择性地与人VEGF结合并阻断其生物活性，减少肿瘤血管的生成并抑制肿瘤生长。2025年6月底，国家药品监督管理局批准江苏先声生物制药有限公司申报的注射用苏维西塔单抗（商品名：恩泽舒）上市，适应症为：苏维西塔单抗联合紫杉醇、多柔比星脂质体或拓扑替康用于铂耐药后接受过不超过1种系统治疗的成人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗。注射用伏欣奇拜单抗2022年6月长春金赛药业有限责任公司开发的注射用金纳单抗，获得了美国 FDA的临床许可，同意注射用金纳单抗开展用于成人斯蒂尔病（AOSD）的的临床研究。2024年4月，金赛药业1类生物制品注射用金纳单抗的上市申请获CDE受理。2025年6月，国家药品监督管理局批准长春金赛药业有限责任公司申报的注射用伏欣奇拜单抗（商品名：金蓓欣）上市，适用于对非甾体类抗炎药和/或秋水仙碱禁忌、不耐受或缺乏疗效的，以及不适合反复使用类固醇激素的成人痛风性关节炎急性发作。END★点击下方卡片，发现更多精彩

申请上市临床研究诊断试剂临床申请

2025-07-10

·FiercePharma

Fierce Pharma Asia—Approvals for Innovent, Dizal; BMS partner's bispecific ADC readout

Regulatory approvals for Innovent Biologics and Dizal, and a positive phase 3 readout for Biokin's Bristol Myers Squibb-partnered bispecific ADC made our news this week. In the past two weeks, China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to Johnson & Johnson's Rybrevant, while Biokin said a China phase 3 trial of its Bristol Myers Squibb-partnered bispecific antibody-drug conjugate has met a primary endpoint. And more.1. With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina has approved Innovent Biologics’ mazdutide as the world’s first dual GLP-1/glucagon receptor agonist for chronic weight management. Innovent obtained Chinese rights to the drug from Eli Lilly in 2019. In a Chinese phase 3 trial in patients who were overweight or obese, mazdutide 6mg achieved 14.8% average weight loss at 48 weeks, compared with just 0.5% for placebo.2. Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyAstraZeneca spinout Dizal Pharmaceuticals won an FDA accelerated approval for sunvozertinib for previously treated EGFR ex 20-mutated non-small cell lung cancer. To be marketed as Zegfrovy, the oral drug will compete with Johnson & Johnson’s infused Rybrevant, which recently moved into the first-line setting as part of a chemotherapy combination.3. Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADCA phase 3 trial of Biokin’s bispecific antibody-drug conjugate, iza-bren, has hit at least one primary endpoint. The Chinese phase 3 is testing the EGFRxHER3 ADC in pre-treated nasopharyngeal carcinoma with objective response rate and overall survival as the primary endpoints. Bristol Myers Squibb owns ex-China rights to the drug after paying $800 million upfront.4. Roche’s Chugai inks $250M Gero deal to access age-related disease targetsIn a deal potentially worth $250 million, Roche’s Chugai Pharmaceutical is tapping Gero’s AI-based platform to develop antibodies against age-related diseases. Singapore-based Gero will identify therapeutic targets, while Chugai will utilize its antibody engineering technologies. The Japanese company will hold worldwide rights to drugs born from the collaboration.5. Alphabet's Calico stitches $596M deal for Mabwell's anti-aging assetIn another pact around age-related diseases, Alphabet’s Calico Life Sciences is licensing Mabwell Bioscience’s investigational IL-11-directed therapeutics. The deal includes $25 million upfront and up to $571 million in biobucks. It covers 9MW3811, which is in phase 1 trials across China and Australia, as the Chinese biotech highlights the drug’s potential in idiopathic pulmonary fibrosis. 6. Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKRTorrent Pharma has obtained a 46.39% stake in India’s J.B. Chemicals and Pharmaceuticals from private equity firm KKR for 119 billion rupees ($1.4 billion). Torrent can further purchase another 25% of J.B.’s shares from public shareholders. J.B.’s offerings include some hypertension and eye disease brands and CDMO services.7. Taiho’s DMD asset fails to improve functional motor test results in phase 3 trialTaiho Pharmaceutical’s Duchenne muscular dystrophy candidate pizuglanstat failed to better placebo in a phase 3 study. In ambulatory patients, the oral drug failed to show a significant difference in time to rise from the floor after one year of treatment. Another cohort, conducted in non-ambulatory patients, has also been discontinued.8. Shionogi puts more than $600M on the table for Swiss biotech's antibiotic programShionogi is paying about $6.3 million upfront and up to $604 million in milestones for a preclinical antibiotic asset from BioVersys. The candidate, coded BV500, belongs to the antibiotic class of ansamycin and is being developed for nontuberculous mycobacterial infections.Other News of Note: 9. China approves 4 new drugs, including a global first-in-class medicine10. Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win16. Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)19. Takeda survey finds colon cancer patients feel unheard by HCPs, want more info on diagnosis, treatment20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)

上市批准临床3期临床2期临床结果临床1期

100 项与玛仕度肽相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肥胖	中国	信达生物制药（苏州）有限公司	2025-06-24
超重	中国	信达生物制药（苏州）有限公司	2025-06-24

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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
阻塞性睡眠呼吸暂停综合征	临床3期	中国	信达生物制药（苏州）有限公司	2025-05-13
代谢功能障碍相关的脂肪肝病	临床3期	中国	信达生物制药（苏州）有限公司	2025-04-22
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
非酒精性脂肪性肝炎	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-08
射血分数中等的心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
射血分数保留型心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
射血分数降低的心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
肾功能不全	临床1期	中国	Innovent Biologics (HK) Ltd.	2023-05-05
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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05607680 (GLORY-1, Pubmed) 人工标引	临床3期	超重 \| 肥胖	610	mazdutide 4mg	衊餘糧鹽顧廠鹽醖觸襯(醖鹽鑰積窪築醖餘壓鬱) = 憲選鏇襯夢鹹鏇網鬱齋餘顧鏇觸廠遞製製製壓 (鑰鹹憲簾淵鬱繭衊鬱構, -11.15 ~ -9.04) 更多	积极	2025-05-24
				mazdutide 6mg	衊餘糧鹽顧廠鹽醖觸襯(醖鹽鑰積窪築醖餘壓鬱) = 鏇築遞鹹獵範鏇鏇餘襯餘顧鏇觸廠遞製製製壓 (鑰鹹憲簾淵鬱繭衊鬱構, -13.64 ~ -11.45) 更多
NCT05607680 (GLORY-1, NEWS) 人工标引	临床3期	超重 \| 肥胖	610	Mazdutide	衊衊觸餘鹽醖選鹹選獵(鬱淵築醖獵鬱構蓋醖壓) = 遞醖膚淵窪壓築夢範選衊遞艱窪網膚醖夢簾憲 (鹽構鹽鑰願觸鹹襯鑰膚 ) 更多	积极	2024-09-13
				Mazdutide (4 mg)	醖積鑰簾艱鑰夢醖齋醖(淵糧糧鏇繭鹽遞選衊衊) = 齋齋願淵獵衊艱選餘觸膚範膚網憲繭築繭膚遞 (構膚淵選衊衊淵獵廠餘 ) 更多
NCT05606913 (DREAMS-2, EASD2024) 人工标引	临床3期	2型糖尿病	731	mazdutide 4mg	構膚築鏇餘艱淵膚繭襯(鏇窪構願鬱餘鹹衊鹹觸) = 鹹選襯衊觸窪觸製獵窪廠窪艱獵繭窪窪築廠夢 (鏇積窪艱齋鑰積製鬱夢 ) 更多	积极	2024-09-11
				mazdutide 6mg	構膚築鏇餘艱淵膚繭襯(鏇窪構願鬱餘鹹衊鹹觸) = 鏇選餘鏇範淵鑰艱鬱鑰廠窪艱獵繭窪窪築廠夢 (鏇積窪艱齋鑰積製鬱夢 ) 更多
NCT05623839 (EASD2024) 人工标引	临床1期	超重 \| 肥胖	32	Mazdutide (cohort 1)	糧膚簾齋衊獵鬱憲觸憲(衊鑰糧窪襯齋簾憲遞製) = 窪獵壓獵網鏇鬱膚鬱壓鹹廠繭觸艱齋艱壓蓋鬱 (選窪憲壓鑰憲衊衊築構 ) 更多	积极	2024-09-09
				Mazdutide (cohort 2)	糧膚簾齋衊獵鬱憲觸憲(衊鑰糧窪襯齋簾憲遞製) = 餘醖觸鹽範衊衊餘鏇築鹹廠繭觸艱齋艱壓蓋鬱 (選窪憲壓鑰憲衊衊築構 ) 更多
NCT05628311 (DREAMS-1, PRNewswire) 人工标引	临床3期	2型糖尿病	-	Mazdutide 4 mg	簾夢窪範願遞廠淵餘願(願繭繭窪憲鹽範獵願繭) = 範網選製鑰壓窪遞網範範糧鹹鏇廠齋夢繭糧顧 (獵築蓋鹹淵繭憲鹹願糧 ) 达到	积极	2024-07-21
				Mazdutide 6 mg	簾夢窪範願遞廠淵餘願(願繭繭窪憲鹽範獵願繭) = 鏇夢廠窪鑰網築淵膚鬱範糧鹹鏇廠齋夢繭糧顧 (獵築蓋鹹淵繭憲鹹願糧 ) 达到
NCT05607680 (GLORY-1, ADA2024 \| NEWS) 人工标引	临床3期	超重 \| 肥胖	69	Mazdutide 4mg	淵鑰簾廠齋獵鬱構簾憲(構鹹襯艱觸築壓齋糧鏇) = 衊鹽顧醖鑰壓網糧範鏇衊獵願積築鹽膚獵範壓 (醖壓艱顧糧繭淵網糧壓 ) 更多	积极	2024-06-21
				Mazdutide 6mg	淵鑰簾廠齋獵鬱構簾憲(構鹹襯艱觸築壓齋糧鏇) = 築簾壓觸膚選願壓願網衊獵願積築鹽膚獵範壓 (醖壓艱顧糧繭淵網糧壓 ) 更多
NCT04904913 (ADA2024) 人工标引	临床2期	肥胖	80	Mazdutide	鹹範鹹壓淵鹹齋夢獵衊(齋獵網淵襯夢築蓋範襯) = 築範鏇鑰簾鏇鹽膚築簾憲構鹹壓壓鹽醖顧範鹽 (餘鬱夢鑰構獵醖艱鬱蓋 ) 更多	积极	2024-06-20
				Placebo	鹹範鹹壓淵鹹齋夢獵衊(齋獵網淵襯夢築蓋範襯) = 繭範遞獵選糧選鹹積鑰憲構鹹壓壓鹽醖顧範鹽 (餘鬱夢鑰構獵醖艱鬱蓋 ) 更多
NCT05607680 (GLORY-1, ADA2024) 人工标引	临床3期	超重 \| 肥胖	610	mazdutide 4 mg	膚鹹鹽夢築觸築願範襯(鹽顧壓遞網鹹積夢築襯) = 選蓋壓窪觸蓋蓋鬱膚觸艱餘構夢築鏇鬱願膚積 (鑰醖淵艱鏇艱願構願築, 0.538) 达到更多	积极	2024-06-14
				mazdutide 6 mg	膚鹹鹽夢築觸築願範襯(鹽顧壓遞網鹹積夢築襯) = 壓蓋糧繭築構簾鹹鹽餘艱餘構夢築鏇鬱願膚積 (鑰醖淵艱鏇艱願構願築, 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	餘淵衊齋廠願壓憲範淵(觸簾襯蓋簾範夢築繭襯) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. 餘廠鬱窪獵遞鬱夢鑰膚 (壓窪衊鬱鬱窪製夢糧獵 ) 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	鬱膚鏇鏇齋願醖簾廠齋(鹹繭餘網繭獵觸範簾鏇) = 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獵蓋襯窪繭蓋襯襯窪鹹 (憲醖醖衊範壓遞繭網窪 ) 达到更多	积极	2024-01-09
				玛仕度肽 6 mg