主要目的：采用正葡萄糖钳夹技术，在中国健康男性受试者中比较甘李药业股份有限公司生产的重组甘精胰岛素注射液（3ml：900单位/支）（受试制剂，T）与赛诺菲安万特制药有限公司甘精胰岛素注射液（来优时®TOUJEO，参比制剂，R）的药代动力学（PK）和药效动力学（PD）的生物等效性。次要目的：评价甘精胰岛素注射液在中国健康男性受试者中的安全性。

开始日期2021-10-13

申办/合作机构

甘李药业股份有限公司

NCT04236895

/ Completed临床1期

A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus

Primary objectives:
To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.
max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes
To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes
Secondary objectives:
To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)
To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

开始日期2018-07-10

申办/合作机构

甘李药业股份有限公司

NCT03371082

/ Completed临床3期

An Open Label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus in Adult Subjects With Type 1 Diabetes Mellitus.

Primary Objective:
•To evaluate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity
Secondary Objective:
Immunogenicity:
• To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®.
Safety:
•To evaluate the safety of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®.
Efficacy:
•To evaluate the efficacy of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®.

开始日期2017-10-31

申办/合作机构

甘李药业股份有限公司

100 项与重组甘精胰岛素 (甘李药业) 相关的临床结果

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100 项与重组甘精胰岛素 (甘李药业) 相关的专利（医药）

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项与重组甘精胰岛素 (甘李药业) 相关的文献（医药）

2024-06-01·Diabetes, obesity & metabolism

Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study

Article

作者: Fitz‐Patrick, David ; Hart, Terence ; Tidman, Raymond ; Nakhle, Samer ; Puente, Orlando ; Arora, Samir ; Rendell, Marc ; Maheshwari, Hiralal ; Warren, Mark ; Denham, Douglas ; Christofides, Elena A. ; Young, Douglas ; Chadha, Anurekha ; Reed, John ; Norwood, Paul ; Johnson, Kimball A. ; Huffman, David ; Lillestol, Michael ; Soufer, Joseph ; Sugimoto, Danny ; Rizzardi, Barbara ; Bays, Harold

Abstract:

Aim:

To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus.

Methods:

This was a phase 3, multicenter, open‐label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment‐induced anti‐insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment‐induced AIA development to the prespecified margins.

Results:

The percentages of participants positive for treatment‐induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of −2.1 percentage points and a 90% CI (−7.6%, 3.5%) (predefined similarity margins: −10.7%, 10.7%). The difference in glycated haemoglobin was −0.08% (90% CI, −0.23, 0.06). The overall percentage of participants with any treatment‐emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups.

Conclusions:

GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.

2023-12-01·Diabetes, obesity & metabolism

Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU‐ und US‐sourced reference insulins

Article

作者: Lu, Jia ; Zijlstra, Eric ; Li, Longling ; Chen, Wei ; Heise, Tim ; Plum-Mörschel, Leona ; Xie, Tian ; Gan, Zhongru ; Andersen, Grit ; Hao, Chunyue ; He, Anshun

Abstract:

Aim:

For the successful approval and clinical prescription of insulin biosimilars, it is essential to show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to the respective reference products sourced from the European Union and the United States.

Methods:

Three phase 1, randomized, double‐blind, three‐period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL‐Asp, n = 36), lispro (GL‐Lis, n = 38) and glargine (GL‐Gla, n = 113), all manufactured by Gan & Lee pharmaceuticals, to the respective EU‐ and US‐reference products in healthy male participants (GL‐Asp and GL‐Lis) or people with type 1 diabetes (GL‐Gla). Study participants received 0.2 U/kg (aspart and lispro) or 0.5 U/kg (glargine) of each treatment under automated euglycaemic clamp conditions. The clamp duration was 12 h (aspart and lispro) or 30 h (glargine). Primary PK endpoints were the total area under the PK curves (AUCins.total) and maximum insulin concentrations (Cins.max). Primary PD endpoints were the total area under the glucose infusion rate curve (AUCGIR.total) and maximum glucose infusion rate (GIRmax).

Results:

Bioequivalence to both EU‐ and US‐reference products were shown for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%–125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the GL insulins.

Conclusion:

GL‐Asp, GL‐Lis and GL‐Gla are bioequivalent to their EU‐ and US‐reference products.

2019-05-01·Advances in therapy3区 · 医学

A Propensity Score Matched Comparison of Brand and Biosimilar Basal Insulin in Non-Critical Hospitalized Patients with Type 2 Diabetes Mellitus

3区 · 医学

Article

作者: Jiang, Jikang ; Zhang, Lei ; Gao, Weiguo ; Dong, Yanhu ; Hu, Xia ; Dong, Chao

INTRODUCTION:

Comparisons between brand and biosimilar basal insulin in hospitalized patients are lacking. We aimed to compare the efficacy and safety of brand insulin glargine vs. biosimilar insulin glargine in non-critical hospitalized patients with type 2 diabetes mellitus (T2DM).

METHODS:

This retrospective study was conducted using the electronic medical records of 194,006 patients at the Qingdao Endocrine and Diabetes Hospital between January 2006 and December 2017. A total of 476 patients diagnosed with T2DM, hospitalized, and treated with subcutaneous insulin glargine were included. After propensity score matching (1:3), patients who received biosimilar insulin glargine (Basalin) (n = 34) were compared to a matched group of patients who received brand insulin glargine (Lantus) (n = 101). Outcome measures were changes in fasting blood glucose (FBG), the incidence of hypoglycemia, and insulin dose.

RESULTS:

Compared to patients who received Basalin, patients who received Lantus achieved more reduction in FBG during insulin treatment (- 1.24 mmol/L vs. - 2.20 mmol/L; p = 0.04) and had a lower mean FBG at the end of treatment (8.20 mmol/L vs. 7.26 mmol/L; p = 0.12). Patients in Basalin and Lantus groups had a comparable mean daily dose of basal insulin at initiation (0.19 vs. 0.18 IU/kg; p = 0.30) and end of treatment (0.21 vs. 0.21 IU/kg; p = 0.99), and a similar duration of basal insulin treatment (16.4 vs. 15.3 days; p = 0.74). Hypoglycemia was infrequent in both Basalin and Lantus treatment (one vs. four patients, respectively; p = 1.00) and no severe hypoglycemic events were reported.

CONCLUSION:

In a non-critical hospital setting, subcutaneous treatment with Lantus brought significant FBG improvement without increased hypoglycemic risk.

项与重组甘精胰岛素 (甘李药业) 相关的新闻（医药）

2025-04-30

·健识局

胰岛素市场发生重大变化，通化东宝上市以来首次亏损

4月30日，通化东宝发布财报显示：2024年公司实现营业收入20.09亿元，相比于去年同期减少34.66%。利润总额亏损约1.43亿元，相比去年同期减少110.52%。这是通化东宝近十多年来首次亏损。2023年通化东宝的净利润还超过11亿元。让投资者气愤的是，在年报发布前通化东宝曾两次修正2024年度经营业绩预告，都没提到要亏损。1月20日，通化东宝第一次发业绩预告，表示去年净利润大幅下降，但公司依然处于盈利状态；而2月27日、4月27日，通化东宝两次发布修正公告，最终向外界坦诚：去年亏损。通化东宝亏损的原因其实很简单，去年，新一轮胰岛素集采在全国开展，通化东宝的产品降价降猛了，同时还要对渠道和库存商品调价，所以销售额和利润双双下降。这一情况甘李药业也遇到过，不过甘李已经挺过来了。2024年，甘李药业交出了一份不错的答卷：全年营业收入30.45亿元，同比增长16.77%；归属于母公司所有者的净利润6.15亿元，同比增长80.75%。通化东宝也必须承受阵痛的过程，只是痛过之后，也能像甘李药业那样很快复苏吗？错押“二代胰岛素”通化东宝最核心的产品是胰岛素，而且之前一直以二代胰岛素见长。2021年，国家第一轮胰岛素集采时，通化东宝的三代胰岛素还没成气候，报价较高，最终未获得最大的市场份额。当时甘李药业三代胰岛素大幅降价60%以上，进入集采范围，开始向下挤占二代胰岛素的市场。其核心产品甘精胰岛素注射液报出了每支48.71元的低价。集采政策实施两年之后，情况果然如甘李料想的那样，中国胰岛素临床使用发生变化：三代胰岛素的需求量占比已达70%，较集采之前增长36%。这从一个侧面说明，集采让高价药品平价化，吸引了更多患者的使用。2022年至2024年，甘李药业的营收从17.12亿元，跃升至30.45亿元，享受到改革的政策红利。但是，通化东宝就不同了，替代效应逼迫二代胰岛素加快退出市场，再如何守也是守不住了，通化东宝业绩遭遇重挫。“输在起跑线上”的通化东宝只能积极应对，在新一轮的集采调整策略。根据年报显示：在2024年胰岛素专项集采接续工作中，公司采取了以价换量策略，全线产品平均降价15%，以A类或A1类中选。2024下半年，集采接续工作全国多地实施以来，通化东宝的多款“三代胰岛素”新增准入上千家医院。今年3月，公司在投资者互动平台回应称：虽然2024年业绩受多重因素影响承压，但第三季度起营收已迅速恢复，预计2025年公司持续受益于集采，胰岛素类似物持续放量带来的双重红利，推动公司业绩的进一步恢复与增长。根据通化东宝的财报显示：2025年，公司第一季度营业收入为6.52亿元，同比增长10.17%。抢先开发GLP-1相比于集采策略失误，通化东宝与甘李药业的商标侵权案也令人唏嘘。早在2011年，甘李药业发现通化东宝研发的甘精胰岛素冻干粉针剂的名称为“长舒霖”（甘精胰岛素注射液)，与自研产品“长秀霖”（重组甘精胰岛素注射液）的读音仅一字之差，涉嫌构成侵权，随后向原国家工商行政管理总局商标局、北京知识产权法院和北京高级人民法院等多个部门提起诉讼，均败诉。这起商标官司历经十年之久。2021年1月，甘李药业向江苏省苏州市中级人民法院提起商标侵权及不正当竞争诉讼。2025年2月，江苏省高院终审判决通化东宝败诉，需向甘李药业支付6131.21万元赔偿。终审法院认定通化东宝商标注册存在“恶意”，与甘李药业“长秀霖”构成不正当竞争。此外，2024年的研发项目失利，同样是通化东宝业绩亏损的诱因之一。根据年报显示：通化东宝终止可溶性甘精赖脯双胰岛素注射液的临床研究开发工作，已经资本化的研发费用6455.82万元全部计提资产减值准备，同时对2018年已经支付给法国SA ADOCIA公司的商业化权利款金额2.54亿元确认为损失。这两项损失扣税后造成公司净利润减少2.70亿元。终止研发管线对通化东宝来说并非坏事。可溶性甘精赖脯双胰岛素注射液一旦强行上市，不仅要面临与德谷门冬双胰岛素竞争的局面，日后还要承担集采降价的风险。在及时止损的同时，通化东宝又引进了长效 GLP-1 产品司美格鲁肽注射液，目前已正在中国开展临床Ⅲ期试验。目前，通化东宝在长效GLP-1产品的进度上领先于甘李药业。当前GLP-1产品成为行业研发热点，诺和诺德、礼来、恒瑞、华东医药等多个药企积极布局，这种趋势对传统的胰岛素市场构成了潜在的威胁。通化东宝未来能否依靠三代胰岛素实现替代？依托集采获得的4500万支协议量能否实现渠道转化？一切有待时间来验证。撰稿｜小米编辑｜江芸贾亭运营｜李木子插图｜视觉中国声明：健识局原创内容，未经许可请勿转载“近视神药”的销售，搞砸了！教科书级破局！艾伯维免疫业务狂飙16.6%，翻篇专利悬崖重塑增长逻辑新事 | 76亿元的交易黄了

财报带量采购核酸药物

2025-03-11

·PipelineReview

Gan & Lee Pharmaceuticals Announced First Participant Dosed in the US Phase 2 Clinical Study of Bofanglutide (GZR18) Injection for Overweight or Obesity

BEIJING, China and BRIDGEWATER, NJ, USA I March 10, 2025 I Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the first participant has been successfully dosed in a Phase 2 clinical trial of bofanglutide (research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee, in the US participants with overweight or obesity. Notably, bofanglutide is the first GLP-1 receptor mono-agonist to undergo a head-to-head comparison with tirzepatide for evaluating the efficacy in body weight management globally. This Phase 2 clinical trial (ClinicalTrials.gov registration number: NCT06737042) was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity. The study plans to enroll 285 subjects, who will be randomized to receive either 24 mg, 36 mg, or 48 mg of bofanglutide bi-weekly, 15 mg of tirzepatide once-weekly, or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment. Previously, a Phase 1 study (NCT06548997) of bofanglutide injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential [1] . The initiation of head-to-head clinical study for bofanglutide versus tirzepatide, marking a new phase in Gan & Lee’s GLP-1 innovation. This milestone underscores the company’s ambition to challenge the leading GLP-1 therapy in the global market for weight management, aiming to provide a better treatment option for patients with overweight or obesity worldwide. Reference: [1].Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 Mar 3. doi: 10.1111/dom.16285. Epub ahead of print. PMID: 40028667. About Bofanglutide (GZR18) Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly GLP-1 receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly GLP-1 RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of GLP-1 RAs, and significant reductions in both blood glucose levels and body weight. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin), fast-acting lispro injection (Prandilin ® ™), fast-acting aspart injection (Rapilin), mixed protamine zinc lispro injection (25R) (Prandilin ® ™25), aspart 30 injection (Rapilin30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine) ® . In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets ® . In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. SOURCE: Gan & Lee Pharmaceuticals

临床1期临床2期上市批准

2025-03-01

·医药投资部落

国产胰岛素龙头的十年一梦

2015年3月，通化东宝股价最高摸到8.84元/股。 2025年3月，通化东宝最新收盘价格为7.45元/股。在胰岛素这个号称长坡厚雪的赛道上，作为国产龙头企业的通化东宝，十年的时间恍如黄粱一梦。 2024年1月，通化东宝披露2024年业绩预告显示，公司预计2024年年度实现归属净利润约为4052.77万元，同比减少约96.53%。公开数据显示，这将是通化东宝自2007年以来最差的业绩。胰岛素集采是造成通化东宝净利大幅下滑的重要原因之一。通化东宝表示，2024年新一轮胰岛素集采在全国各省市开始陆续落地实施，公司各胰岛素产品中标价格均有不同程度下降，导致销售收入下滑。同时，由于新一轮胰岛素集采落地带来公司产品价格下调的普遍预期，公司商业客户对库存进行控制与调整，对公司发货造成一定影响，因此销售收入同比下滑。与集采如影随形的，是同行之间的激烈竞争。 2024年2月26日，通化东宝发布2024年业绩预告更正公告：经财务部门再次测算，预计2024年实现归属于上市公司股东的净利润约为1164.21万元，同比减少约99%。业绩预告更正的主要原因，是通化东宝与同行甘李药业之间的官司。 2021年1月，甘李药业起诉通化东宝生产销售的“长舒霖”甘精胰岛素，侵害其“长秀霖”商标权，并构成不正当竞争。根据最终判决，通化东宝应赔偿甘李药业经济损失6000万元。导致通化东宝2024年业绩大亏的，还有终止的研发管线。 2024年7月11日，通化东宝发布公告称，经审慎考量，公司决定终止可溶性甘精赖脯双胰岛素注射液研发项目（以下简称“THDB0207注射液”）临床研究开发工作。可溶性甘精赖脯双胰岛素注射液，是一种创新的胰岛素制剂，它结合了长效的甘精胰岛素和速效的赖脯胰岛素，与预混胰岛素相比，甘精赖脯双胰岛素能够强化空腹血糖控制，并减少“肩效应”引发的低血糖风险。在6年前的2018年4月26日，通化东宝公司与法国SA ADOCIA公司签订许可协议，通化东宝有偿获得BioChaperone® Combo（胰岛素基础餐时组合）在所有大中华地区，以及马来西亚、新加坡等国家和地区的独家开发、生产并商业化权利。 2022年5月，通化东宝先后启动了CT046、CT047、CT048三项I期临床试验，研究主要目的在于评估THDB0207注射液的临床药理学特征。 2023年10月，通化东宝收到上述三项关键I期临床试验的总结报告，研究结果显示达到主要终点目标。 2024年二季度，在I期临床试验的基础上，综合多位中国权威临床专家的意见，得出需要补充开展II期临床试验的结论。主要原因是，基于THDB0207注射液I期临床试验的数据，在中国最新临床实践下，有必要继续探索该产品的临床价值，其中对夜间低血糖特征的充分考察尤为重要。但是这个时候，通化东宝的这款产品，已经完全不占市场先机。目前，在国内已上市的与THDB0207注射液类似的双胰岛素注射液，有诺和诺德公司于2019年5月获批上市的德谷门冬双胰岛素。此外，还有大批在研管线：吉林惠升的德谷门冬双胰岛素生物类似药于2023年已经报产，联邦制药、东阳光、重庆宸安、中美华东这4家公司的德谷门冬双胰岛素生物类似药已于2022年至2024年期间进入III期临床试验阶段，其研发进度都大幅领先于通化东宝的THDB0207注射液。在这种不利局面下，通化东宝做出了终止研发的决策。通化东宝项目研发资本化金额6455.82万元全额计提资产减值准备，同时对2018年已经支付给SA ADOCIA公司与该项目相关的预付商业化权利款金额2.54亿元确认为损失。上述两项会计处理，将减少公司2024年年度净利润2.70亿元。应该说，2024年的通化东宝，运气实在有点差。但是好转的迹象也正在显露。一方面，在最新一轮胰岛素集采中，公司胰岛素产品尽管价格有所下降，但全部胰岛素产品均成功以A/A1类中标，除基础签约量外，还获得了约1,000万支分配量，并在医院准入方面实现巨大的提升和突破。另外一方面，公司的出海战略正在取得成绩。 2024全年，通化东宝的海外业务大幅增长，预计实现收入超亿元，同比接近翻倍。通化东宝的人胰岛素注射液上市许可申请已获得EMA正式受理；同时公司与健友股份已就门冬、甘精、赖脯3款胰岛素达成战略合作，共同进军美国胰岛素市场，目前相关临床试验正在稳步推进中。此外，在创新药领域，公司进展也不小。 2月25日，通化东宝宣布完成了注射用THDBH120的一项I期临床试验，并获得临床试验总结报告，试验达到主要终点目标。注射用THDBH120是通化东宝重点在研的胰高血糖素样肽-1 (GLP-1) 受体和葡萄糖促胰岛素分泌多肽 (GIP) 受体双靶点激动剂，属于一类创新药，有望成为更长效的治疗糖尿病和肥胖的重磅药物。医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过2000篇存量精选医药研究报告每年新增额外500篇

财报IPO专利侵权临床1期

100 项与重组甘精胰岛素 (甘李药业) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE04	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	中国	甘李药业股份有限公司	2005-05-10

未上市

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
1型糖尿病	临床3期	美国	甘李药业股份有限公司	2017-10-31
1型糖尿病	临床3期	捷克	甘李药业股份有限公司	2017-10-31
1型糖尿病	临床3期	德国	甘李药业股份有限公司	2017-10-31
1型糖尿病	临床3期	匈牙利	甘李药业股份有限公司	2017-10-31
1型糖尿病	临床3期	波兰	甘李药业股份有限公司	2017-10-31
1型糖尿病	临床3期	西班牙	甘李药业股份有限公司	2017-10-31
2型糖尿病	临床3期	美国	甘李药业股份有限公司	2017-10-31

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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


NCT03371082 (GLITTER1, CTgov)	临床3期	1型糖尿病	576	Gan & Lee Insulin Glargine Injection (Gan & Lee Insulin Glargine Injection)	築醖壓廠廠遞齋憲衊壓(糧簾襯廠餘獵餘製餘顧) = 糧餘選壓選廠網簾積選鏇觸鏇衊願壓夢艱遞鹽 (顧願遞觸獵構夢繭衊繭, 88.88) 更多	-	2024-05-14
NCT03371082 (GLITTER1, CTgov)	临床3期	1型糖尿病	576	Lantus® (Lantus®)	築醖壓廠廠遞齋憲衊壓(糧簾襯廠餘獵餘製餘顧) = 網獵齋顧餘衊構窪鬱艱鏇觸鏇衊願壓夢艱遞鹽 (顧願遞觸獵構夢繭衊繭, 332.90) 更多	-	2024-05-14
NCT03371108 (EASD2023)	临床3期	2型糖尿病	567	GL Glargine Injection	構鬱鹽鬱夢廠憲積構獵(獵鹹憲夢窪鬱艱餘衊積) = 築鑰積觸鬱淵網鑰觸顧鹹鬱淵壓淵願鹽選糧觸 (糧顧衊襯窪積鹹製鹽憲, -0.13 ~ 0.26)	积极	2023-10-05
NCT03371082 (EASD2023)	临床3期	1型糖尿病	576	GL Glargine Injection	壓醖鏇餘構壓遞網醖顧(獵觸製糧簾鏇築糧製鹹) = similar rates of TEAEs reported in both groups (90.2% vs. 92.4%) 觸構製簾選築齋蓋鏇夢 (窪鹽鹽鑰醖製鏇憲範選 ) 更多	积极	2023-10-05
NCT03371108 (GLITTER 2, CTgov)	临床3期	2型糖尿病	567	Gan & Lee Insulin Glargine Injection (Gan & Lee Insulin Glargine Injection)	鑰餘獵夢構夢襯鹹鏇繭 = 艱簾築選網齋網餘觸膚積遞願憲鹹遞範鹹築膚 (艱窪膚選餘餘鹽憲壓憲, 艱鹹顧積獵製餘廠網鹹 ~ 艱窪淵蓋築醖鏇網鹹壓) 更多	-	2022-03-23
NCT03371108 (GLITTER 2, CTgov)	临床3期	2型糖尿病	567	Lantus® (Lantus®)	鑰餘獵夢構夢襯鹹鏇繭 = 簾窪積壓鑰範衊壓鹽範積遞願憲鹹遞範鹹築膚 (艱窪膚選餘餘鹽憲壓憲, 遞鹹淵餘範構艱鹹範鏇 ~ 襯網網壓鑰鏇遞糧廠糧) 更多	-	2022-03-23