预约演示

更新于：2025-06-06

Insulin Glargine/Lixisenatide

甘精胰岛素利司那肽

更新于：2025-06-06

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

+ [2]

非在研机构

Sanofi-Aventis Deutschland GmbH

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

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-

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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

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

CTRI/2024/10/075222

/ Not yet recruiting临床4期

A 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 - iGlarLixi Phase 4 study in India

开始日期2024-10-28

申办/合作机构

Sanofi Healthcare India Pvt Ltd.

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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154

项与甘精胰岛素利司那肽相关的文献（医药）

2025-06-01·DIABETES OBESITY & METABOLISM

Safety and clinical effectiveness of iGlarLixi in people with type 2 diabetes mellitus in Mexico

Article

作者: Anguiano, Luis ; Sañudo‐Maury, Maria Elena ; Rosas‐Guzman, Juan ; Navarro‐Lara, Alberto ; Sauque‐Reyna, Leobardo

Abstract:

Aims:

To evaluate the safety and effectiveness of iGlarLixi in people with type 2 diabetes mellitus (T2DM) in clinical practice in Mexico.

Materials and Methods:

This was a prospective, observational, multicentre study in adults with T2DM who were prescribed iGlarLixi in routine clinical practice in Mexico. The participants were followed for 24 ± 1 months. The primary endpoint included the incidence proportion, incidence rate of adverse drug reactions (ADRs), serious ADRs and the severity of suspected ADRs possibly related to iGlarLixi throughout the study.

Results:

The study included 330 participants (mean ± SD age: 57.8 ± 11.9 years, weight: 77.1 ± 17.7 kg, duration of diabetes: 14.1 ± 9.9 years, and female: 55.5%). During the 24‐month study, 59 participants (17.9%; 95% confidence interval [CI]: 13.9–22.4) reported 95 ADRs, with a mean of 0.164 events per participant‐year. The most commonly reported ADRs were gastrointestinal disorders (11.2%), with nausea being the most frequent (7.3%). HbA1c decreased from 9.5% at baseline to 7.3% at the end of the study. Additionally, 51.7%, 64.6% and 86.3% of participants achieved the glycaemic target of HbA1c < 7%, FPG < 110 mg/dL and PPG < 180 mg/dL, respectively, at the end of the study. A significant decrease (p < 0.0001) in 7‐point self‐monitoring plasma or capillary blood glucose was observed from baseline to 3, 6, 12 and 24 months post iGlarLixi initiation.

Conclusions:

iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets.

2025-06-01·DIABETES OBESITY & METABOLISM

Efficacy and safety of iGlarLixi versus IDegAsp in people with type 2 diabetes inadequately controlled with basal insulin: A systematic literature review and network meta‐analysis of non‐Asian studies

Review

作者: Hafidh, Khadija ; Mehta, Roopa ; Faraoun, Khadra ; Li, Xuan‐Tony ; Anaforoğlu, İnan ; Djaballah, Khier ; Lauand, Felipe ; Home, Philip ; Serafini, Paul ; Pourrahmat, Mir‐Masoud

Abstract:

Aims:

To estimate the relative treatment effect of iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide) versus premixed insulin IDegAsp (insulin degludec plus insulin aspart) in people with type 2 diabetes (T2D) who advanced from basal insulin to iGlarLixi or IDegAsp in non‐Asian studies.

Materials and Methods:

Randomized controlled trials (RCTs) were identified in a systematic review by searching Embase (including congress abstracts from 2021 to 2023), MEDLINE® and CENTRAL on 10 October 2023. Treatment outcomes from non‐Asian RCTs for people with T2D previously treated with basal insulin, who switched to iGlarLixi or IDegAsp, were compared using a network meta‐analysis (NMA). Data analysis was performed using R, version 4.0.2.

Results:

The NMA included four RCTs (N = 2535). The results of the NMA showed that iGlarLixi (n = 810) was associated with a significantly greater reduction in HbA1c versus IDegAsp (n = 454) (mean difference [MD]: −0.39 [95% credible interval, CrI: −0.58, −0.21] %‐units). iGlarLixi was also associated with a significantly greater likelihood of achieving an HbA1c of <7.0% (risk ratio: 1.42, 95% CrI: 1.18, 1.71). A greater reduction in postprandial glucose was observed with iGlarLixi versus IDegAsp (MD: −1.38 [95% CrI: −2.15, −0.63] mmol/L). A body weight benefit that favoured iGlarLixi versus IDegAsp was documented (MD: −1.54 [95% CrI: −2.26, −0.84] kg). Hypoglycaemia evaluation was inconclusive due to definitional differences between trials.

Conclusions:

Once‐daily iGlarLixi was associated with superior blood glucose control and body weight benefit compared with IDegAsp in insulin‐experienced populations with T2D in non‐Asian RCTs.

2025-05-01·ADVANCES IN THERAPY

Safety of iGlarLixi in Japanese People with Type 2 Diabetes: A Post-marketing Database Study

Article

作者: Hatanaka, Makiko ; Terauchi, Yasuo ; Morimoto, Yukiko ; Takahashi, Yoko ; Kaneto, Hideaki

INTRODUCTION:

In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).

METHODS:

In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA ± oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin ± OADs or long-acting insulin ± OADs (Cohort 2B).

RESULTS:

Of the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44 days, respectively, there were zero and 0.011 (95% CI 0.006-0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA ± OADs and OADs alone groups, with a median follow-up duration of 76 and 101 days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin ± OADs group and 623 people in the long-acting insulin ± OADs group, with a median follow-up duration of 73 and 62 days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed.

CONCLUSION:

Consistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment.

项与甘精胰岛素利司那肽相关的新闻（医药）

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

2025-03-05

·摩熵医药

价格暴跌超50%！140亿胰岛素市场，甘李药业等国产企业借势崛起……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近年来，随着GLP-1受体激动剂、SGLT-2抑制剂等新型糖尿病治疗药物的涌现，糖尿病治疗选择日益丰富。然而，胰岛素凭借其独特的作用机制和广泛的适用人群，依然在糖尿病治疗市场中占据核心地位。在医疗技术进步和患者需求多样化的推动下，胰岛素市场正经历深刻变革。对于医药企业而言，理解市场竞争格局、把握市场趋势，不仅是生存的关键，更是实现可持续发展的必由之路。摩熵咨询的《胰岛素市场研究专题报告》揭示了胰岛素市场的现状，并前瞻性地指出了行业发展方向。本文基于该报告部分内容，聚焦甘精胰岛素等产品的发展现状与竞争态势，并展望胰岛素市场的未来走向，旨在为相关各方把握市场机遇、应对挑战提供有力参考。 01 甘精胰岛素市场竞争格局 1.甘精胰岛素2023年全国销售额约42亿元，原研占据过半市场甘精胰岛素为第三代基础胰岛素类似物，是全球首个每日一次的长效胰岛素类似物，原研企业为法国赛诺菲公司，商品名为来得时。甘精胰岛素分别于2000年4月获得美国FDA批准上市，用于治疗1型和2型糖尿病，2004年进入中国市场，目前国内生产企业包括甘李药业、珠海联邦制药、通化东宝药业等。在国内销售额方面，据摩熵医药数据库统计，甘精胰岛素注射液于2021年达到销售峰值84.79亿元，2021年纳入胰岛素专项集采后销售额急剧下滑，目前销售额仅约41.77亿元。数据来源：摩熵医药销售数据库在竞争格局方面，赛诺菲作为原研企业，凭借其品牌优势和技术实力，稳居市场第一，市场份额约52%。而本土企业甘李药业等则通过仿制药的研发和生产，逐渐占据了三成的市场份额。 2.专项集采五家企业中标，国产产品院内销售额/量小幅提升 2021年专项集采中，甘精胰岛素注射液总采购量为3125万支，采购金额约19.03亿元，为采购量/金额第三大品种，中标企业包括原研赛诺菲和四家国产厂商，包括甘李药业、通化东宝、东阳光、联邦制药。专项集采后，赛诺菲院内销售额占比从57.02%略微下滑至53.38%，销售量占比从52.99%下滑至45.25%，国产仿制产品销售额/量均有所提升，2023年销售额/量占比分别达46.67%、54.75%。数据来源：摩熵医药药品集中采购数据库 3.甘精胰岛素注射液各级医院市场分析（以海南省为例）据摩熵医药药物流向数据显示，以海南省为例，甘精胰岛素注射液2023年各季度销售量和销售额如下图：甘精胰岛素注射液2023年销售额TOP3医院（海南省为例）分别为海南省人民医院、海南医学院第二附属医院、海南医学院第一附属医院。数据来源：摩熵医药药物流向数据甘精胰岛素注射液2023年销售市场在各级医院均有分布，其中三级医院为主要销售市场，各季度三级医院销售额占比均达到63%以上。 02 精蛋白重组人胰岛素市场竞争格局 1.精蛋白重组人胰岛素2023年全国销售额约47亿元，预混30R为主要品种精蛋白重组人胰岛素为第二代产品，属于中效胰岛素，目前我国已上市的制剂按照速效胰岛素加入的比例，包括常规、30R、40R、50R四个品种。精蛋白重组人胰岛素混合注射液（30R）峰值持续时间较长，2-8小时可达最大效应，作用持续时间为12-24小时，能够较好地模拟人体胰岛素的自然分泌模式，该品种为目前国内市场精蛋白重组人胰岛素主要品种。受集采影响，精蛋白重组人胰岛素销售额从2020年开始连续下滑，常规、30R、40R、50R四个品种2023年合计销售额为47.10亿元，其中30R销售额最大，超过40亿元。诺和诺德、通化东宝、珠海联邦制药为主要玩家，合计占据80%以上市场。 2.预混30R专项集采中选企业达8家，最高降幅超70% 2021年专项集采中，常规、30R、40R、50R四个品种平均降幅约43.85%、48.27%、42.08%、41.92%，中选企业数分别有6、8、1、4家。精蛋白重组人胰岛素混合注射液（30R）采购量为6745万支，为采购量最大品种，采购金额约19.63亿元。甘李药业旗下3ml:300iu（笔芯）规格中选价格低至17.89元，而江苏万邦降幅最高，达70.17%。图片来源：摩熵咨询的《胰岛素市场研究专题报告》 03 门冬胰岛素市场竞争格局 1.门冬胰岛素2023年全国销售额约53亿元，原研占据主导地位门冬胰岛素为第三代胰岛素类似物，属于速效胰岛素，原研企业为诺和诺德，于1999年首次在欧洲上市，2000年在美国上市，2005年进入国内市场，此后，诺和诺德分别在2005年、2012年推出预混30、预混50产品。近五年，门冬胰岛素全国销售额受第六批集采影响较大，从2021年峰值96.26亿元下滑至53.42亿元，预混30是销售额最大的品种，2023年销售额约33.98亿元。竞争格局方面，原研企业诺和诺德处于绝对优势地位，目前市场份额近90%。 2.第六批集采平均降幅约50.24%，预混30产品采购量/金额位居第二 2021年专项集采中，门冬胰岛素常规、预混30、预混50三个品种平均降幅约52.71%、49.52%、40.00%，中选企业数分别有5、3、1家，整体平均降幅约50.24%。门冬胰岛素30注射液采购量约4478万支，采购金额约19.27亿元，为采购量/金额第二位的大品种。甘李药业3ml:300iu（笔芯）规格降幅高达65.89%，中选单价低至24.56元。 04 胰岛素市场趋势分析趋势1：三代胰岛素替代加速，新型胰岛素制剂蓄势待发未来第三代胰岛素将逐步替代二代产品。我国历年胰岛素市场结构呈现明显的变化趋势，受到新一代产品的冲击，二代胰岛素市场份额逐年下降，2023年二代胰岛素整体份额下滑至19%，而第三代胰岛素（胰岛素类似物）因其更接近生理性的作用机制和更少的副作用，2023年占据了六成胰岛素市场，未来也将继续保持主导地位。新型胰岛素制剂开启糖尿病治疗新纪元。诺和诺德旗下伊柯胰岛素为全球首款胰岛素周制剂，每周仅需注射一次，在人体内半衰期约196小时，注射频率降低可提高患者治疗接受度和依从性；赛诺菲甘精胰岛素利司那肽注射液为甘精胰岛素与利司那肽的固定比例复方制剂，可兼顾降糖疗效、低血糖风险和体重获益；未来新型胰岛素制剂将为糖尿病患者提供更多治疗选择。趋势2：国产胰岛素全球竞争力显著提升，出海正成为大势所趋市场规模方面，2023年全球胰岛素市场规模约367亿美元，而北美、欧洲仍是主要的市场，合计市场份额超过80%，为国产胰岛素产品出海提供了广阔的市场空间；产品价格方面，在美国市场占据主导地位的赛诺菲、诺和诺德、礼来三家企业旗下胰岛素产品价格显著高于国内，高定价为国产胰岛素全球化发展提供了机遇。出海正成为全行业共识，甘李药业、通化东宝两家企业率先开启胰岛素出海，多款产品海外研发及申报顺利推进，未来更多国产胰岛素产品将登上国际舞台，参与全球化竞争。结语胰岛素专项集采重塑了国内市场格局，加速国产替代与价格理性回归；而三代胰岛素迭代与新型制剂研发则为行业注入长期增长动力。未来，具备创新研发能力与全球化视野的企业将主导市场竞争。 END 本文为原创文章，转载请留言获取授权市场研究专题报告二十四----胰岛素完整报告领取方式近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准带量采购医药出海核酸药物

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
-	-	A10AE54	-

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

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


NCT05413369 (SoliD, CTgov)	临床3期	2型糖尿病	582	Insulin glargine/Lixisenatide+SGLT2 inhibitor+Metformin (iGlarLixi)	鬱繭願鏇繭範壓獵範糧(襯繭範網蓋鹹窪範積製) = 鹽憲艱膚鬱窪齋餘膚範遞製醖觸遞醖膚膚齋選 (繭築糧鹽鹽餘窪廠鑰膚, 0.05) 更多	-	2024-10-30
				SGLT2 inhibitor+IDegAsp+Metformin (IDegAsp)	鬱繭願鏇繭範壓獵範糧(襯繭範網蓋鹹窪範積製) = 膚鬱顧簾鏇餘選簾積齋遞製醖觸遞醖膚膚齋選 (繭築糧鹽鹽餘窪廠鑰膚, 0.05) 更多
NCT05413369 (SoliD, ADA2024) 人工标引	临床3期	2型糖尿病	582	iGlarLixi	範鑰窪築鑰鏇鹽選獵鬱(選遞襯艱淵簾網餘糧憲): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多	非劣	2024-06-21
				IDegAsp
ADA2024	N/A	2型糖尿病	-	iGlarLixi	築構築願願窪積齋膚築(餘窪鹽廠夢齋醖餘選壓) = 積餘簾網窪顧艱憲顧範糧淵膚遞遞築鹹蓋膚積 (齋窪鹽構襯簾襯鹹鏇繭 ) 更多	-	2024-06-14
ADA2024	N/A	2型糖尿病	-	iGlarLixi	遞夢築醖窪願艱廠網淵(簾衊鹽襯繭憲獵獵糧壓) = 窪廠鹽齋鬱鹽願獵觸襯觸壓積艱獵壓糧艱艱衊 (選蓋襯醖顧構窪獵獵窪, 1.18 ~ 1.71)	-	2024-06-14
NCT05114590 (374-P, ADA2024)	临床4期	2型糖尿病	124	Sulfonylurea (SU) users	艱淵遞築製積壓鏇遞築(遞壓襯鏇網鹹網蓋製製) = only reported by SU users 築醖獵膚夢醖願鏇鹽顧 (憲鑰衊積鬱餘蓋衊觸鏇 ) 更多	积极	2024-06-14
ADA2024	N/A	-	-	iGlarLixi	範築衊淵選願製衊餘鏇(鬱廠齋壓鏇鏇餘築鏇獵) = 餘艱襯窪醖選蓋餘觸範選築鑰積鑰醖廠壓壓衊 (繭築構鹹簾獵鹹壓壓製, -3.4 ~ 0.75) 更多	-	2024-06-14
				MDI	範築衊淵選願製衊餘鏇(鬱廠齋壓鏇鏇餘築鏇獵) = 獵構糧鬱壓淵積糧壓鏇選築鑰積鑰醖廠壓壓衊 (繭築構鹹簾獵鹹壓壓製, -1.2 ~ 3.3) 更多
ADA2024	N/A	-	-	iGlarLixi	衊衊膚壓鏇膚蓋鑰鹽鑰(衊膚壓顧衊憲壓鹹遞鹽) = 蓋簾簾鏇衊築壓觸壓淵廠鬱選糧餘願選鹽膚齋 (製繭選淵製鬱鏇蓋獵鬱, 4.3) 更多	-	2024-06-14
				MDI	衊衊膚壓鏇膚蓋鑰鹽鑰(衊膚壓顧衊憲壓鹹遞鹽) = 鹽糧網製鹹壓艱獵壓範廠鬱選糧餘願選鹽膚齋 (製繭選淵製鬱鏇蓋獵鬱, 3.7) 更多
ADA2024	N/A	2型糖尿病	-	iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (BMI ≥30 kg/m2)	鹹壓製齋艱鏇鬱醖積醖(憲襯選襯壓餘觸觸鹽鬱) = low in both groups 構製範夢夢餘繭簾憲觸 (簾淵鹹鏇獵鏇範遞鹹鹽 ) 更多	-	2024-06-14
				iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (BMI <30 kg/m2)
ADA2024	N/A	2型糖尿病	-	iGlarLixi	壓構鑰願膚膚構繭蓋窪(觸構衊構艱憲遞鹹蓋衊) = 獵願鑰鏇鬱醖構觸蓋蓋繭膚觸獵鹽鹹網獵繭網 (顧廠網壓廠艱襯憲壓窪 ) 更多	-	2024-06-14
				BID PI dosing	壓構鑰願膚膚構繭蓋窪(觸構衊構艱憲遞鹹蓋衊) = 簾壓網鬱鹹餘願壓糧築繭膚觸獵鹽鹹網獵繭網 (顧廠網壓廠艱襯憲壓窪 )
NCT05114590 (374-P \| 839-P \| Soli-CGM, CTgov)	临床4期	2型糖尿病	124	Insulin glargine/Lixisenatide	積積選夢構選遞簾齋觸(夢範餘鏇糧憲窪憲膚選) = 膚鬱範鑰襯鬱襯製憲遞鹹齋築醖簾築構衊壓繭 (壓蓋鏇鏇餘膚範鹹衊膚, 鹹選窪衊鹽壓淵衊餘鑰 ~ 築鬱鹹廠窪醖簾艱製網) 更多	-	2024-05-24