预约演示

更新于：2025-08-27

Insulin Glargine/Lixisenatide

甘精胰岛素利司那肽

更新于：2025-08-27

概要

基本信息

药物类型

激素

别名

AVE0010/Lantus、iGlarLixi、Insulin glargine/Lixisenatide

+ [13]

靶点

GLP-1R x INSR

作用方式

激动剂

作用机制

GLP-1R激动剂(胰高血糖素样肽-1激动剂)、INSR激动剂(胰岛素受体激动剂)

治疗领域

内分泌与代谢疾病

在研适应症

2型糖尿病

非在研适应症-

原研机构

Sanofi

在研机构

Sanofi Winthrop Industrie SASanofi KK

Sanofi-Aventis U.S. LLC

+ [2]

非在研机构

赛诺菲（中国）投资有限公司Sanofi-Aventis Recherche & Développement SA

Sanofi-Aventis Deutschland GmbH

权益机构

Zealand Pharma A/S

Royalty Pharma Plc

最高研发阶段批准上市

首次获批日期

瑞士 (2002-05-16),

2型糖尿病

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构/序列

Sequence Code 4851β

Sequence Code 31960α

关联

项与甘精胰岛素利司那肽相关的临床试验

NCT07117240

/ Enrolling by invitation临床4期IIT

Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of Insulin Therapy and Fixed-ratio Combination Therapy (Insulin + GLP-1 Receptor Agonist)

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases. Despite their therapeutic efficacy, they are associated with significant metabolic side effects. In the proposed research, the aim is to assess the metabolic efficacy and safety of fixed-ratio combination therapy (basal insulin + GLP-1 receptor agonist) compared to standard insulin therapy in patients with SID. In a selected group of patients, a randomised clinical trial would be conducted to assess the potential benefits of GLP-1 receptor agonists in the management of SID.

开始日期2025-07-10

申办/合作机构

Warszawski Uniwersytet Medyczny

NCT06716424

/ Recruiting临床4期

Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA

This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.

开始日期2025-01-06

申办/合作机构

Sanofi

NCT06671587

/ Recruiting临床4期

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).
Study details include:
* The study duration per participant will be approximately up to 24 weeks.
* The treatment duration will be up to 20 weeks.
* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
* Health measurement/Observation: change in TIR as the primary endpoint
* Intervention name: iGlarLixi and Gla-100
* Participant gender: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: type 2 diabetes
* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.

开始日期2024-12-10

申办/合作机构

Sanofi

100 项与甘精胰岛素利司那肽相关的临床结果

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100 项与甘精胰岛素利司那肽相关的转化医学

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100 项与甘精胰岛素利司那肽相关的专利（医药）

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150

项与甘精胰岛素利司那肽相关的文献（医药）

2025-08-11·DIABETES OBESITY & METABOLISM

Long-term effectiveness of iGlarLixi treatment in people with type 2 diabetes in the United States: The soli-durability 24-month observational study.

Article

作者: Li, Xuan ; Amani, Mohammed E A ; Lauand, Felipe ; Alvarez, Agustina ; Adaş, Mine ; Khunti, Kamlesh ; Anderson, John ; Malik, Rayaz A ; Russo, Giuseppina

AIM:

To evaluate the effectiveness and safety of a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) over 24 months in people with type 2 diabetes (T2D).

METHODS:

In this retrospective, observational study, data were collected from the Optum Market Clarity® database in the United States. People with T2D aged ≥18 years, previously treated with oral antidiabetic drugs ± basal insulin or glucagon-like peptide-1 receptor agonists, who initiated iGlarLixi between 1 January 2017 and 31 March 2020 and received ≥1 iGlarLixi prescription were included. The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, achievement of HbA1c <7%, change in body weight and rate of hypoglycaemia (defined as inpatient or outpatient claims, or blood glucose <70 mg/dL) every 3 months over 24 months.

RESULTS:

In total, 1685 people were included in this analysis (mean age, 58.4 years; 52.6% female). In the overall population, including imputed values, mean ± standard deviation (SD) baseline HbA1c (9.3 ± 1.8%) was reduced by 0.9% to 8.3 ± 1.8% at 24 months. A HbA1c target of <7% was achieved in 22.2% of people at 24 months. Mean ± SD body weight remained stable from baseline (102.1 ± 24.2 kg) to 24 months (101.9 ± 23.3 kg). The hypoglycaemia event rate was 16.1 per 100 person-years (P100PY) at baseline and decreased to 11.4 P100PY at 24 months.

CONCLUSIONS:

iGlarLixi initiation was associated with improved glycaemic control, without body weight change or increased hypoglycaemia over 24 months.

2025-08-01·DIABETES OBESITY & METABOLISM

What is the ‘real‐world’ experience with fixed‐ratio combination therapy (insulin + GLP‐1 receptor agonist) in routine clinical practice? Take‐home messages for clinicians regarding key outcomes

Review

作者: Frias, Juan Pablo

Abstract:

Aims:

The fixed‐ratio combinations (FRCs) of a basal insulin and glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA), IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), offer a once‐daily injectable treatment option for adults with type 2 diabetes (T2D), combining complementary mechanisms of action to target both fasting and postprandial hyperglycaemia. While randomized controlled trials have demonstrated their efficacy and safety, real‐world evidence (RWE) provides important insights into their effectiveness, tolerability and use across routine clinical practice.

Materials and Methods:

This is a narrative review of selected real‐world studies assessing the FRCs IDegLira and iGlarLixi in adults with T2D. Studies assessing the use of FRCs to intensify and simplify therapy, as well as their use in special populations such as older adults were reviewed and are summarized.

Results:

Among individuals inadequately controlled on oral antihyperglycaemic drugs (OADs), basal insulin ± OADs, or GLP‐1 RAs, initiation of FRC therapy consistently improved glycaemic outcomes, supported modest weight loss or stability, and was associated with a low risk of hypoglycaemia. FRCs have also been evaluated as a strategy for simplifying complex insulin regimens. Transitions from basal–bolus or premixed insulin to FRCs maintained or improved glycaemic control while reducing total daily insulin dose and injection burden.Evidence in special populations and clinical contexts further supports the utility of FRCs. In older adults, FRC use was associated with reductions in HbA1c and hypoglycaemia risk, along with improvements in treatment satisfaction and functional measures. During Ramadan fasting, iGlarLixi demonstrated favourable glycaemic control, low hypoglycaemia incidence, modest weight loss and high adherence. Studies assessing glycaemic control using continuous glucose monitoring showed improvements in time in range, reductions in time above range and stable time below range, indicating enhanced glycaemic stability without increased risk of hypoglycaemia.Two real‐world head‐to‐head studies comparing IDegLira and iGlarLixi found both FRCs to be effective and well tolerated. IDegLira was associated with greater weight loss and lower insulin dose requirements, while iGlarLixi showed advantages in postprandial glucose control. Both agents demonstrated significant improvements in HbA1c and low rates of hypoglycaemia.

Conclusions:

Collectively, these real‐world studies confirm that FRCs are effective, safe and patient‐centred treatment options for adults with T2D. Their simplified dosing, metabolic benefits and favourable safety profiles support their use for both therapy intensification and de‐intensification across a broad spectrum of clinical scenarios. These findings reinforce results from randomized controlled trials, providing further confidence in the role of FRCs in contemporary diabetes care.

2025-08-01·DIABETES OBESITY & METABOLISM

An overview of randomized clinical trials of fixed‐ratio combinations of basal insulin plus GLP‐1RA (injectable therapy): Lessons for advancing therapy in people with type 2 diabetes

Review

作者: Fanelli, Carmine G. ; Porcellati, Francesca ; Bolli, Geremia B. ; Perseghin, Gianluca ; Horowitz, Michael ; Owens, David R. ; Lucidi, Paola

Abstract:

Advancing therapy in T2DM with injectables, i.e., basal insulin (BI) and GLP‐1 receptor agonists (GLP‐1RAs) is recommended after the failure of oral glucose lowering agents (OGLAs), BI alone, or BI in combination with OGLAs, especially in persons with, or at high risk of atherosclerotic cardiovascular disease (ASCVD). BI and GLP‐1RAs can be administered separately or as fixed‐ratio combinations (FRCs) for daily use (degludec+liraglutide, IDegLira, glargine‐100 + lixisenatide iGlarLixi) or weekly use (icodec+semaglutide, IcoSema). The currently available FRCs IDegLira and iGlarLixi differ in their respective BI as well as GLP‐1RA components. Liraglutide predominantly stimulates glucose‐dependent endogenous insulin secretion in response to nutrient challenges. In contrast, the rapid‐acting lixisenatide primarily delays gastric emptying over a few hours post‐dosing with little or no impact on insulin secretion. IDegLira in DUAL studies and iGlarLixi in LixiLan studies appear to have equivalent lowering effects on HbA1c, although IDegLira achieves a greater reduction in body weight. The weekly FRC IcoSema is superior to weekly insulin icodec (COMBINE 1), to semaglutide (COMBINE 2), and non‐inferior to basal‐bolus insulin therapy (COMBINE 3). Comparison of IcoSema with glargine‐100 is ongoing (COMBINE 4). However, all FRCs are limited by the low GLP‐1RA dose relative to the insulin delivered. Whenever higher GLP‐1RA doses are required (i.e., in obese people), the option of separate dosing of BI and GLP‐1RA with independent titration of each component should be considered.

项与甘精胰岛素利司那肽相关的新闻（医药）

2025-06-07

·CPHI制药在线

翰森制药GLP-1/GIP双受体激动剂HS-20094授权再生元；国产9价HPV疫苗获批 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多，首先是审评审批方面，非常值得关注的是多个新药获批新适应症，比如阿斯利康的度伐利尤单抗、BMS的罗特西普以及康方生物的卡度尼利单抗；其次是研发方面，2个新药启动Ⅲ临床，比如齐鲁制药启动QL1706 联合贝伐珠单抗一线治疗晚期卵巢透明细胞癌疗效的III期临床，丽珠医药/鑫康合生物医药启动LZM012注射液（XKH004）治疗中重度斑块状银屑病的III期临床试验；再次是交易及投融资方面，国内值得一说的就是，翰森制药GLP-1/GIP双受体激动剂HS-20094授权再生元，总交易额超20亿美元。本期盘点包括审评审批、研发以及交易及投融资三大板块，统计时间为2025.6.2-6.6，包含35条信息。审评审批NMPA上市批准1、6月4日，阿斯利康宣布，英飞凡®（通用名：度伐利尤单抗）获 NMPA 批准，作为单药用于在接受铂类药物为基础的放化疗后未出现疾病进展的局限期小细胞肺癌（LS-SCLC）成人患者的治疗。2、6 月4日，BMS 宣布其注射用罗特西普（商品名：利布洛泽）在国内获批新适应症，治疗极低危、低危和中危骨髓增生异常综合征引起的贫血且需要定期输注红细胞的成人患者。罗特西普是近20年来首个获批用于治疗较低危骨髓增生异常综合征贫血的创新药物，有望重新定义需要定期输血的较低危MDS患者贫血治疗。3、6月4日，万泰生物发布公告，称其九价人乳头瘤病毒疫苗（大肠埃希菌）（商品名称：馨可宁®9）已经获药监局批准上市。这是国内首个上市的国产9价HPV疫苗。4、6月4日，艾伯维今天宣布，NMPA已批准乌帕替尼缓释片（15 毫克，每日一次，商品名瑞福）用于治疗巨细胞动脉炎（GCA）成人患者。该批准距其在美国和欧盟获批仅一个多月，这使得乌帕替尼缓释片成为目前中国首个且唯一获批用于治疗巨细胞动脉炎（GCA）成年患者的口服JAK抑制剂。5、6月4日，NMPA官网显示，信立泰阿利沙坦酯吲达帕胺缓释片已获得上市批准。该药是一款ARB/利尿剂类复方缓释制剂，此次获批用于治疗原发性高血压。6、6月4日，NMPA官网显示，康方生物研发的PD-1/CTLA-4双特异性抗体卡度尼利单抗在国内获批新适应症，联合含铂化疗联合或不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌。申请7、6月2日，华东医药宣布，由中美华东申报的雷珠单抗注射液（研发代码：HJY28）上市申请已获得 NMPA 受理，这是国内第 2 款报上市的雷珠单抗生物类似药。8、6月4日，CDE官网显示，荣昌生物维迪西妥单抗新适应症申报上市，适应症为用于既往接受过至少一种系统治疗，或在辅助治疗期间或完成辅助治疗后12个月内复发，不可切除或转移性HER2低表达乳腺癌患者。这是维迪西妥单抗申报上市的第4项适应症。9、6月5日，三生国健宣布其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NMPA递交上市申请并获受理。目前，我国尚无IL-1β同靶点药物上市。10、6月5日，信达生物与和黄医药联合宣布，信迪利单抗和呋喹替尼联合疗法用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性的肾细胞癌患者的新药上市申请已获NMPA受理。呋喹替尼和信迪利单抗的联合疗法于2024年12月取得国家药监局附条件批准，用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。临床批准 11、6月5日，挚盟医药宣布公司自主研发的，用于治疗慢性乙型肝炎的新一代病毒核衣壳抑制剂ZM-H1505R（Canocapavir, ZM-H1505R），正式获得CDE同意，开展针对治疗慢性乙型肝炎的3期关键性临床试验。ZM-H1505R是一种强效的HBV核衣壳抑制剂，可以有效抑制HBV核衣壳形成的小分子候选化合物，2期临床试验结果表明有望显著提高对NA应答不佳病人的抗病毒应答率，从而减少肝硬化和肝癌的发生。优先审评12、6月3日，CDE官网显示，赛诺菲的甘精胰岛素利司那肽注射液（II）和甘精胰岛素利司那肽注射液（I）拟纳入优先审评，用于血糖控制不佳的成人2型糖尿病患者，在饮食和运动基础上联合其他口服降糖药物，改善血糖控制。突破性疗法13、6月3日，CDE官网显示，舶望制药1类新药BW-20507注射液拟纳入突破性治疗品种，拟定适应症为慢性乙型肝炎病毒感染。BW-20507是一种靶向乙型肝炎病毒（HBV）信使RNA S区域的siRNA分子，近日因其 I/IIa 期临床研究数据显示治疗慢乙肝患者的效果显著，被国家药监局纳入突破性疗法。 14、6月3日，CDE官网显示，科伦博泰的芦康沙妥珠单抗（sac-TMT，商品名：佳泰莱®）联合PD-L1单抗（KL-A167）一线治疗驱动基因阴性的局部晚期或转移性非鳞状非小细胞肺癌（nsq-NSCLC）拟纳入突破性疗法认定。这是该产品即将被授予的第5项突破性疗法认定。芦康沙妥珠单抗是国内首款获得完全批准上市的国产ADC，2024年11月获NMPA批准，用于治疗既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）成人患者，2025年3月又被NMPA批准用于治疗经EGFR-TKI和含铂化疗治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者。 15、6月5日，CDE官网显示，维眸生物1类新药VVN461滴眼液拟纳入突破性治疗，适应症为：非感染性前葡萄膜炎（NIAU）.VVN461是维眸生物自主研发的一款非激素靶向抗炎创新药物，也是全球范围内将JAK抑制剂运用于眼科抗炎领域的首次突破性创新，拥有高活性高选择性的第四代JAK1/TYK2双靶点小分子抑制剂，通过清晰的抗炎机理，并借助公司专有技术平台“快闪透粘膜药物输送平台（FTDS）”开发的高端复杂制剂，实现在眼表的高效递送和优异的治疗效果。 16、6月6日，CDE官网显示，泰德制药1类新药TDI01混悬液拟纳入突破性治疗，适应症为：既往经过2线不超过5线系统治疗的中重度慢性移植物抗宿主病（cGVHD）。TDI01混悬液是一种高选择性的Rho/Rho相关卷曲螺旋形成蛋白激酶2（ROCK2）抑制剂。FDA上市批准 17、6月6日，拜耳宣布，美国 FDA 已批准其口服雄激素受体抑制剂（ARi）达罗他胺（商品名：诺倍戈）联合雄激素剥夺疗法（ADT）治疗转移性去势敏感性前列腺癌（mCSPC），也被称为转移性激素敏感性前列腺癌（mHSPC）。EMA上市批准 18、6月6日，阿斯利康宣布，阿可替尼与维奈克拉（联合或不联合奥妥珠单抗）的固定疗程方案已在欧盟获得批准，用于治疗先前未接受治疗的慢性淋巴细胞白血病（CLL）成年患者。研发临床状态19、6月3日，Clinicaltrials网站显示，信达启动了一项IBI362（玛仕度肽）15mg的I/II期临床研究（NCT07000955），旨在评估IBI362 15mg 在中重度肥胖患者中的耐受性和药代动力学研究。 20、6月3日，康诺亚在药物临床试验登记与信息公示平台官网上登记了一项CDH17靶向ADC药物 CM518D1 治疗晚期实体瘤的I/II期临床研究。据公开资料显示，这是该药首次启动临床。 21、齐鲁制药“艾托组合抗体”III期临床试验开启：6 月 3 日，ClinicalTrials 官网登记了一项旨在评估 QL1706 联合贝伐珠单抗一线治疗晚期卵巢透明细胞癌疗效的III期临床研究（NCT07002346）。 22、6月5日，ClinicalTrials.gov官网显示，诺华登记了一项[225Ac]Ac-ETN029治疗晚期DLL3表达实体瘤患者的I期临床研究（登记号：NCT07006727）。 23、6月5日，药物临床试验登记与信息公示平台官网显示，丽珠医药与鑫康合生物医药登记了一项LZM012注射液（XKH004）治疗中重度斑块状银屑病患者的III期临床试验。临床数据24、6月2日，再鼎医药在2025年美国临床肿瘤学会（ASCO）年会上公布了其DLL3靶向抗体偶联药物zocilurtatug pelitecan（ZL-1310）的1a/1b期临床研究的更新数据：ZL-1310针对广泛期小细胞肺癌（ES-SCLC）显示出包括颅内缓解在内的强劲的抗肿瘤活性。 25、6月3日，信达生物在2025年美国临床肿瘤学会（ASCO）年会上口头报道了IBI343（创新型抗CLDN18.2 ADC）治疗晚期胰腺癌临床1期研究数据更新：在经过更长时间的随访后，基于更成熟的PFS和OS数据，IBI343在治疗CLDN18.2表达阳性的晚期胰腺癌患者中展现出优秀的治疗潜力。 26、6月3日，康宁杰瑞在2025年美国临床肿瘤学会（ASCO）年会上以poster形式公布了HER2双抗偶联药物（ADC）JSKN003的多项临床研究数据，研究成果涵盖铂耐药卵巢癌、HER2阳性乳腺癌、HER2高表达胃肠道肿瘤。 27、6月4日，Vigil Neuroscience宣布其IGNITE开放标签II期临床试验失败。IGNITE是一项开放标签临床试验，旨在评估TREM2单抗Iluzanebart对成人发病的轴突球体和色素胶质细胞白质脑病(ALSP)的潜在治疗作用。 28、6月4日，歌礼宣布其同类首创、每日一次口服小分子脂肪酸合成酶（FASN）抑制剂地尼法司他（研发代号：ASC40）治疗中重度寻常性痤疮的III期临床试验（NCT06192264）达到所有主要、关键次要及次要终点。 29、6月5日，Corcept Therapeutics公布了Dazucorilant 治疗肌萎缩侧索硬化症的II期DAZALS研究数据，未达到ALS功能评分量表（ALSFRS-R）评分下降的主要终点，但总生存期（OS）显著延长。交易及投融资30、6月2日，翰森制药宣布与再生元订立许可协议，授予再生元开发、生产及商业化HS-20094（GLP-1/GIP双受体激动剂）的全球独占许可（不含中国内地、中国香港及中国澳门）。根据协议，翰森制药将获得8,000万美元首付款，并有资格根据该产品开发、注册审批和商业化进展收取最高19.3亿美元里程碑付款，以及未来潜在产品销售的双位数百分比特许权使用费。31、6月2日，法国制药集团赛诺菲宣布以91亿美元收购美国生物制药公司Blueprint Medicines Corporation，旨在强化其在罕见疾病及免疫学领域的产品组合。 32、6月3日，天辰生物宣布完成超2亿元C轮融资。本轮融资由弘晖基金、原有股东方启明创投共同领投，临创蓝湾基金、贝达基金、真脉基金跟投，原有股东方三奕资本、山证创新等持续加码。 33、6月3日，新景智源宣布与百济神州签署了非独家许可协议,将向百济神州授权一项其自主研发的抗原特异性的TCR分子的权益，用于百济神州开发基于iPSC平台的下一代通用型细胞治疗药物。 34、6月4日，拜耳全资拥有并独立运营的子公司 Vividion Therapeutics 宣布，其已获得临床阶段WRN共价抑制剂 VVD-214（RO7589831）的全球独家开发和商业化权利，将增强并补充其创新的肿瘤学开发管线。 35、6月5日，泽璟生物制药与德国默克公司的瑞士子公司AresTradingS.A.签署《服务协议》。泽璟同意授权ATSA作为注射用重组人促甲状腺激素在中华人民共和国境内（为本协议之目的，不包括中国香港特别行政区、中国澳门特别行政区和中国台湾地区）的独家市场推广服务商。END【企业推荐】领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

生物类似药临床3期疫苗上市批准

2025-04-22

·药事纵横

每周注射一次！甘李药业 GZR102 注射液获批临床

4月21日，甘李药业自主研发的GZR102注射液获得国家药监局的临床试验批准，作为一款基础胰岛素与胰高糖素样肽-1受体激动剂（GLP-1RA）的固定比例复方周制剂，GZR102的创新性在于将两种不同机制的降糖药物结合，并实现每周一次给药，这在当前糖尿病治疗领域具有显著的技术优势和临床价值。图源：CDE官网GZR102由甘李药业自主研发的超长效胰岛素GZR4和超长效GLP-1RA博凡格鲁肽（GZR18）以固定比例组成。其中，GZR4通过修饰人胰岛素分子形成“循环存储库”，皮下注射后可缓慢释放胰岛素，满足患者一周的基础胰岛素需求；而GZR18作为GLP-1RA，不仅能促进胰岛素分泌、抑制胰高血糖素释放，还能延缓胃排空、增加饱腹感，从而在降糖的同时实现体重控制。这种组合不仅符合国际临床指南推荐的基础胰岛素联合GLP-1RA治疗方案，还通过减少注射频率，从每日一次到每周一次，大幅提升患者依从性，这在糖尿病长期管理中至关重要。据统计，约50%的糖尿病患者因频繁注射而存在治疗依从性问题，导致血糖控制不佳。目前全球已上市的基础胰岛素/GLP-1RA复方制剂均为日制剂，例如诺和诺德的Xultophy（德谷胰岛素/利拉鲁肽）和赛诺菲的Soliqua（甘精胰岛素/利司那肽）。而GZR102作为首款进入临床阶段的周制剂复方药物，若能成功上市，将填补这一领域的技术空白，并为2型糖尿病患者提供更便捷的治疗选择。近年来，GLP-1类药物因显著的降糖和减重效果成为医药研发的热门赛道。根据统计，全球在研的GLP-1类药物已超过100款，其中诺和诺德的司美格鲁肽（Semaglutide）和礼来的替尔泊肽（Tirzepatide）占据主导地位。司美格鲁肽2023年全球销售额突破200亿美元，而替尔泊肽凭借双靶点（GLP-1/GIP）机制在减重效果上更具优势。甘李药业的GZR18作为对标司美格鲁肽的单靶点GLP-1RA，已在中国进入III期临床，并在美国开展针对肥胖适应症的II期试验，其减重疗效甚至计划与替尔泊肽进行头对头比较。GZR102的复方设计进一步拓展了GLP-1类药物的应用场景。一方面，基础胰岛素与GLP-1RA的联合可协同改善血糖控制，减少低血糖风险；另一方面，GZR18的减重特性能够抵消胰岛素治疗可能导致的体重增加副作用。根据甘李药业的早期临床试验数据，GZR102在降低糖化血红蛋白（HbA1c）和体重控制方面均优于单一组分。这种优势在糖尿病合并肥胖患者中尤为重要，我国成人糖尿病患病率达11.9%，其中超重或肥胖人群占比超过65%。从市场前景看，中国GLP-1类药物市场规模预计到2030年将超过600亿元，而复方制剂因其综合疗效可能占据更大份额。若GZR102能率先上市，甘李药业不仅能在国内市场打破外资垄断，还可依托其国际化布局（如GZR18的美国临床进展）参与全球竞争。尽管GZR102的前景光明，但其研发仍面临多重挑战。首先，复方制剂的药代动力学复杂性较高，需确保两种成分的释放速率和血药浓度曲线匹配。例如，GZR4的超长效特性依赖于与白蛋白的可逆结合，而GZR18作为两周给药一次的GLP-1RA，如何在复方中调整为周制剂并维持疗效，需要精细的剂型设计。其次，III期临床试验的规模和时长可能成为资金与时间的考验。截至2024年9月，GZR102项目的累计研发投入仅1507万元，而单方GZR4和GZR18的III期临床仍在进行中，复方制剂的后续开发成本或将大幅增加。此外，市场竞争的激烈程度不容小觑。除了外资企业的先发优势，国内药企如信达生物、恒瑞医药等也在加速布局GLP-1领域。例如，信达生物的玛仕度肽（IBI362）已进入III期临床，其双靶点设计（GLP-1/GCGR）在减重效果上表现突出。若这些竞品率先获批，可能挤压GZR102的市场空间。长期以来，国内药企在生物类似药和fast-follow药物上表现活跃，但在真正意义上的首创新药（First-in-Class）上成果有限。甘李药业通过GZR4和GZR18的自主研发，展示了在长效化技术上的积累，这为后续开发其他复方或新靶点药物奠定了基础。从更宏观的视角看，GZR102的成功可能推动糖尿病治疗模式的转变。当前，临床指南倾向于阶梯式治疗，如从口服药到胰岛素，而复方制剂有望通过更早的联合治疗实现血糖的快速稳定，减少并发症风险。此外，周制剂的便利性可能吸引更多潜在患者，如工作繁忙的年轻人群，接受规范治疗，从而改善整体疾病管理效率。不过，医药创新始终伴随高风险。GZR102从临床试验到最终上市仍需数年时间，且疗效与安全性需在更大样本中得到验证。投资者需关注甘李药业的研发管线推进效率及资金链稳定性，而患者则期待这一创新疗法能真正兑现“减少注射痛苦，提升生活质量”的承诺。信息来源：CDE官网、中国糖尿病防治指南（2024版）药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期临床2期临床成功

2025-04-15

·ETPharma

Sweet Surrender: Sanofi puts star insulin brand Lantus up for sale, eyes Rs 2,000 crore from Indian pharma giants

Mumbai: Sanofi India has started the process of selling its flagship insulin brand, Lantus, with major domestic pharmaceutical companies such as Glenmark , Dr. Reddy's Laboratories , and Emcure Pharma reportedly in talks to acquire it, people familiar with the matter told ET. The French pharmaceutical giant has set a minimum price of ₹2,000 crore, a sharp reduction from its initial asking price of about ₹3,000 crore, they said. A spokesperson for Sanofi India said: "We do not comment on speculation." Dr. Reddy's, Glenmark and Emcure did not respond to queries. The deal, if it goes through, would catapult Lantus to India's most valuable pharma brand. The people cited above, however, said if there is insufficient bidder interest, Sanofi might instead pursue a licensing agreement with drug makers, similar to what it has done in the past. Prescribed extensively to diabetes patients, Lantus has built a strong reputation, making it the market leader for about two decades. Newer Insulin Options a Threat While it remains a key revenue contributor for Sanofi in India, Lantus' sales have been sliding in recent years. Additionally, a 21% price reduction mandated by the government in 2023 has squeezed margins. Also, insulins are getting better every year, and some - like a once-a-week drug - may further erode Lantus' market share. However, Lantus continues to far outsell many of its rival brands. India's pharmaceutical market is expanding rapidly, driven by over 100 million diabetes patients, making strong brands highly sought-after among drugmakers. For Sanofi, the decision to sell Lantus could be part of a broader strategy to focus on bringing its patented drugs to India, and growing Opella-its consumer healthcare business. Sanofi has of late been making brisk moves in India. Last year, it launched Soliqua, a mix of insulin glargine and lixisenatide, a drug that mimics the GLP-1 hormone to help control sugar and lose weight. The pharma giant also forged partnerships with several firms, including Emcure for the distribution of its cardiovascular drugs, Dr. Reddy's for vaccines, and Cipla for neurology products. Lantus clocked sales of ₹426 crore on a moving annual turnover (MAT) basis for the 12 months through February 2025, according to industry tracker and market researcher PharmaTrac. This marks a decline from ₹588 crore in the same period in 2022. Sales would have been much higher if institutional sales and government supplies were also included, a person said. Danish drugmaker Novo Nordisk leads the domestic market for insulins, with as many as six out of the top ten brands sold in India. The Indian market for insulins-split into a spectrum of brands-is just over ₹4,500 crore, and is growing at 6% annually. Part of a category known as insulin glargine, Lantus has a unique positioning due to its long-acting effect which only requires one shot daily. This gives it an edge over other old insulin types that are needed before meals or twice during the day, making it a sought-after brand. The second-most sold brand of insulin glargine in India is Toujeo, also from the Sanofi stable but with a higher concentration of the dose. Toujeo recorded sales of ₹140 crore this February on a MAT basis. Among Indian drugs, Lantus' rival is Basalog, a brand Eris Pharma acquired last year as part of a broader deal with Biocon Biologics. By Vikas Dandekar ,

并购引进/卖出上市批准

100 项与甘精胰岛素利司那肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	瑞士	Sanofi-Aventis U.S. LLC	2002-05-16

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临床结果

适应症

分期

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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


NCT05413369 (SoliD, CTgov)	临床3期	2型糖尿病	582	Insulin glargine/Lixisenatide+SGLT2 inhibitor+Metformin (iGlarLixi)	膚鑰餘鹽餘襯築遞襯簾(顧鑰選選廠獵鹹醖衊窪) = 簾鬱衊鹽網鹽艱鏇繭鏇夢憲網憲遞鬱鑰築鑰築 (艱遞餘鏇製觸鏇繭願夢, 0.05) 更多	-	2024-10-30
				SGLT2 inhibitor+IDegAsp+Metformin (IDegAsp)	膚鑰餘鹽餘襯築遞襯簾(顧鑰選選廠獵鹹醖衊窪) = 積鏇壓窪獵襯構繭觸築夢憲網憲遞鬱鑰築鑰築 (艱遞餘鏇製觸鏇繭願夢, 0.05) 更多
NCT05413369 (SoliD, ADA2024) 人工标引	临床3期	2型糖尿病	582	iGlarLixi	遞網鬱夢簾糧選餘壓繭(鹽蓋膚網衊艱獵願簾鏇): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多	非劣	2024-06-21
				IDegAsp
NCT05114590 (374-P, ADA2024)	临床4期	2型糖尿病	124	Sulfonylurea (SU) users	觸齋艱觸願襯壓膚願繭(構夢夢鏇衊範繭壓膚簾) = only reported by SU users 築鹽窪範糧鏇構願繭襯 (淵網糧獵餘鬱獵膚鹽齋 ) 更多	积极	2024-06-14
ADA2024	N/A	2型糖尿病	-	iGlarLixi	願鬱繭膚選壓築觸遞鑰(鹽鬱窪糧鏇淵範憲鬱鹹) = 壓範顧齋壓網鬱繭廠廠鑰鹹獵廠餘製構鏇窪鹽 (鏇憲簾鹽艱願鹽遞繭範 ) 更多	-	2024-06-14
				BID PI dosing	願鬱繭膚選壓築觸遞鑰(鹽鬱窪糧鏇淵範憲鬱鹹) = 膚築積淵窪壓鹹獵膚夢鑰鹹獵廠餘製構鏇窪鹽 (鏇憲簾鹽艱願鹽遞繭範 )
ADA2024	N/A	2型糖尿病	-	iGlarLixi	齋餘獵鏇廠鏇選願齋齋(製廠鹽積襯廠廠簾窪襯) = 廠構夢餘鹽鏇鬱簾廠鏇鏇鏇遞製築糧顧觸築壓 (憲壓窪蓋繭鏇範蓋觸築 ) 更多	-	2024-06-14
NCT05114590 (374-P \| 839-P \| Soli-CGM, CTgov)	临床4期	2型糖尿病	124	Insulin glargine/Lixisenatide	衊艱夢鹽壓艱糧鏇襯餘(觸積蓋襯構顧壓積廠遞) = 壓範糧艱壓齋構糧鏇壓顧糧淵網範鬱淵淵鏇餘 (遞鏇淵齋蓋壓鹹鏇壓積, 餘鹽壓鹹鏇鏇簾膚膚醖 ~ 鹽鹹繭鬱顧壓網範獵範) 更多	-	2024-05-24
NCT03798054 \| NCT03798080 (Pubmed)	临床3期	2型糖尿病	-	iGlarLixi	壓淵窪膚夢襯糧遞鑰襯(獵網積鏇積齋鏇顧糧衊): P-Value = 11.45	-	2023-03-30
				Glargine 100 U/mL
NCT03767543 (LixiLan ONE CAN, Pubmed \| Diabetes Obes Metab)	临床3期	2型糖尿病	265	Daily titration of iGlarLixi	遞憲構顧窪鹹製鹽襯襯(壓鬱壓鹹鬱觸鏇願觸遞) = 壓膚鹽鏇鹽壓願壓夢製構鑰糧醖壓窪網積糧憲 (網築簾積築窪鬱遞鹹衊 ) 更多	积极	2022-06-07
				Weekly titration of iGlarLixi	遞憲構顧窪鹹製鹽襯襯(壓鬱壓鹹鬱觸鏇願觸遞) = 顧簾顧範蓋觸範膚糧觸構鑰糧醖壓窪網積糧憲 (網築簾積築窪鬱遞鹹衊 ) 更多
NCT03798054 (LixiLan-O-AP, Pubmed \| Diabetes Obes Metab)	临床3期	2型糖尿病	878	iGlarLixi	衊糧範膚膚廠齋顧蓋積(鑰憲夢範製壓範簾夢襯) = 蓋獵鬱鹹觸獵齋簾構艱襯壓壓顧簾鏇製製齋選 (衊鏇淵鏇鏇鹹鑰繭鑰醖 ) 更多	积极	2022-04-19
				Insulin glargine 100 U/mL	衊糧範膚膚廠齋顧蓋積(鑰憲夢範製壓範簾夢襯) = 觸淵選構構壓醖壓衊膚襯壓壓顧簾鏇製製齋選 (衊鏇淵鏇鏇鹹鑰繭鑰醖 )
NCT00069784 \| NCT02058147 (Pubmed \| J Diabetes Complications)	临床3期	糖尿病并发症	-	iGlarLixi	夢網廠壓淵窪積積簾糧(鏇鏇淵糧糧齋範積鬱鹹) = 衊夢艱糧鹽壓製蓋艱積顧製積壓鑰築夢積遞繭 (醖觸鹹顧鏇簾餘衊窪遞 ) 更多	积极	2022-01-25
				iGlarLixi (Standard of Care)	-