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

NCT03371108

/ 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 2 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 (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from 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 the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26
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

登录后查看更多信息

100 项与重组甘精胰岛素 (甘李药业) 相关的转化医学

登录后查看更多信息

100 项与重组甘精胰岛素 (甘李药业) 相关的专利（医药）

登录后查看更多信息

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 ; Norwood, Paul ; Chadha, Anurekha ; Reed, John ; 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 (AUC ins.total ) and maximum insulin concentrations (C ins.max ). Primary PD endpoints were the total area under the glucose infusion rate curve (AUC GIR.total ) and maximum glucose infusion rate (GIR max ).

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）

2025-12-01

·国家药品监督管理局

2025年12月01日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2400751聚甲酚磺醛阴道栓昆明源瑞制药有限公司————2025年11月28日2CYHB2450576盐酸吡格列酮片成都迪康药业股份有限公司————2025年11月27日3CYHB2500957左氧氟沙星注射液华夏生生药业（北京）有限公司————2025年11月28日4CYHB2502311马来酸阿伐曲泊帕片福建华耀医药科技有限公司————2025年11月28日5CYSB2400321甘精胰岛素注射液甘李药业股份有限公司————2025年11月28日6JXHS2500034瑞米布替尼片北京诺华制药有限公司国药准字HJ202501362025年11月25日7JYHB2500441硫唑嘌呤片广州爱施健贸易咨询有限公司————2025年11月28日8JYHZ2500138多替拉韦钠片葛兰素史克（中国）投资有限公司国药准字HJ201910132025年11月28日9JYHZ2500139多替拉韦钠片葛兰素史克（中国）投资有限公司国药准字HJ201910122025年11月28日10JYHZ2500156碳酸镧咀嚼片北京费森尤斯卡比医药有限公司国药准字HJ20171351 国药准字HJ201713522025年11月28日

申请上市

2025-11-27

·药时空

甘李药业：每月一次GLP-1RA，启动减重III期临床

近日，甘李药业宣布其自主研发的胰高血糖素样肽-1受体激动剂（GLP-1RA）博凡格鲁肽（研发代号：GZR18）注射液，正式启动一项针对肥胖或超重适应症的III期临床试验（GRADUAL-3）。这是博凡格鲁肽在肥胖/超重领域开展的第三项大规模III期临床研究。此次研究将采用每四周一次皮下注射的月制剂给药方案，重点探索博凡格鲁肽注射液在控制和维持体重方面的临床潜力。此前，针对肥胖或超重适应症，甘李药业已启动了两项III期临床研究（GRADUAL-1和GRADUAL-2）。在GRADUAL-2研究中，博凡格鲁肽注射液为全球首个在合并或不合并2型糖尿病的中国成年肥胖/超重受试者中与诺和盈®（司美格鲁肽2.4mg）进行头对头平行对照研究的GLP-1RA，旨在全面评估和验证博凡格鲁肽注射液在肥胖或超重患者的疗效和安全性，并评估其对不同代谢指标与心血管风险因素的综合改善能力。此次月制剂方案的III期临床研究启动，标志着甘李药业在给药便利性上实现了又一次跨越。相较于传统每周注射的GLP-1药物，月制剂将患者每年的注射次数从52次大幅减少至12次，这将显著提升长期用药的依从性。临床数据显示，博凡格鲁肽在减重和降糖方面均表现出色。IIb期研究结果显示，最高剂量组治疗30周后，受试者平均体重较基线下降达17.29%，且体重仍呈持续下降趋势。在2型糖尿病患者中，博凡格鲁肽组受试者糖化血红蛋白（HbA1c）较基线降幅均优于司美格鲁肽对照组。关于甘李药业甘李药业股份有限公司（简称：甘李药业，股票代码：603087.SH）是中国首家成功实现重组胰岛素类似物产业化生产的高科技生物制药企业，拥有完整的胰岛素研发管线。公司现有六款核心胰岛素产品，涵盖五个胰岛素类似物品种：长效甘精胰岛素注射液（长秀霖®）、速效赖脯胰岛素注射液（速秀霖®）、门冬胰岛素注射液（锐秀霖®）、预混精蛋白锌重组赖脯胰岛素混合注射液（25R）（速秀霖®25）、门冬胰岛素30注射液（锐秀霖®30）；以及一个人胰岛素品种：预混精蛋白人胰岛素混合注射液（30R）（普秀霖®30）。产品覆盖长效、速效、预混三大胰岛素功能细分市场。同时，公司还提供配套医疗器械，包括可重复使用的胰岛素注射笔（秀霖笔®）和一次性注射笔用针头（秀霖针®）。未来，甘李药业将持续深耕糖尿病治疗领域，致力于实现产品全面覆盖，巩固并提升市场竞争力。同时，公司正积极开发化学药与生物新药，聚焦代谢性疾病、心血管疾病及其他重要治疗领域。参考资料：甘李药业识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

2025-11-17

·雪球

医药股之殇

我的医药股之殇，近8年已交易过众多医药股，巨亏居多，极少微利，反反复复，不断的不甘，就像希腊神话中西西弗斯的故事。不知道是心性不够，认知不足，还是与医药股相克，或是没有踩准大周期，总之就是不给利。药明康德2021.7.22～2022.12.22巨亏40%，甘李药业2020.7.21～2021.7.15亏35%，丽珠集团2021.6.9～7.27亏18%，爱尔眼科2021.8.13～2022.1.6亏23%，以上四大天王预计巨亏总本金25%，还没算机会成本巨大，严重影响了这几年整体投资回报率。另有恒瑞医药2017.6.5～2024.4.11共5年微利7%，信立泰2017.9.12～2021.10.25共4年微利9%，其它短线（30天内）千金药业、昆药集团5%以内止损，亿帆医药、石药集团、江中药业的中长线（6～24个月）10%止盈，少量华夏眼科、百奥泰中签盈利不计。归结最重要一点：完全不懂医药，肯定都买贵了。目前收缩战线，好好反省，仅留一支重仓药股，就当慢慢练级。涨也赚钱，跌也得利。今天继续大跌磨练一、案例揭示的致命伤药明康德（2021-2023）：认知陷阱：误将CXO行业40%增速当作永续增长，忽视全球生物医药投融资连续5季度下滑（2022Q3-2023Q4）。股价从172元跌至64元，市值蒸发3000亿。周期教训：行业下行时，龙头也难独善其身。抄高瓴资本作业，没看清楚价格。甘李药业（2020集采）：政策误判：以为胰岛素集采"降幅40%"可接受，实际甘精胰岛素降价72%（中标价48.71元/支），净利连续3年亏损。选股硬伤：单品依赖症（胰岛素占比超90%），转型GLP-1进度落后通化东宝2年。当时的新股，自我感觉良好，结果爆锤。丽珠集团（2018-2022）：曾经涨幅牛逼，蒙头转向，自以为是。结果心性溃败，短线自残。。爱尔眼科（2020-2023）：周期悖论：疫情后消费医疗复苏预期过强，忽视"手术量=医生数量×床位"的物理限制。曾经牛股，经常看见，贴近生活，让人坚信强者恒强。唉，其实涨多了都会回归。恒瑞医药（2021创新药）：研发赌博：PD-1单抗上市后年销售峰值仅40亿（预期100亿），2023年研发费用62亿却无重磅管线，估值体系从PE切向DCF时遭遇戴维斯双杀。看别人说每年转股送股后都涨得不错，路径依赖。信立泰（2019氯吡格雷）：转型阵痛：主力产品集采丢标后，试图用器械（左心耳封堵器）对冲风险，但2022年该业务营收仅1.8亿（占总收入6%），证明跨界需要5-10年培育期。二、多维认知重构政策时钟：医保谈判周期（每年11月）、器械集采批次（省际联盟滚动推进）构成择时坐标系，例如2023年骨科脊柱类集采平均降价84%，但关节类已进入温和续约期。太复杂了，难搞，不是精力旺盛，别费神。研发赌局概率：国内创新药临床III期成功率仅25%（Nature数据），需计算"管线估值=成功概率×市场空间"。如曾经信达生物PD-1美国上市被拒，单日市值蒸发80亿港元蛮吓人。现在来点催化剂，单日波动80亿都不算个啥！消费医疗悖论：爱尔眼科的"医疗+消费"属性需验证两个指标：复购率和定价权。三、幸存者路线图仓位纪律：单赛道≤30%（如创新药+CXO+器械组合），个股≤10%，且必须匹配财报季（如药明康德每年4月/10月财报后波动率±20%）。政策套利：在集采落地6个月后布局（如甘李药业2023年集采出清后毛利率回升至82%），重点跟踪医保谈判简易续约规则变化。技术买点：创新药企需等待"3个确认"：临床III期数据公布、NDA受理、医保谈判完成，如荣昌生物维迪西妥单抗三项确认后股价累计上涨380%。大盘$上证指数(SH000001)$继续缩量震荡，世界也不太平，盲猜一下明日：

财报带量采购IPO

100 项与重组甘精胰岛素 (甘李药业) 相关的药物交易

登录后查看更多信息

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,

后查看更多信息

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,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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)	範鬱糧夢淵顧獵壓築壓(夢廠簾淵鏇壓壓餘壓繭) = 獵憲鏇膚築衊鹹製淵獵膚壓簾願顧網蓋醖膚簾 (遞廠壓遞憲構願簾觸築, 88.88) 更多	-	2024-05-14
NCT03371082 (GLITTER1, CTgov)	临床3期	1型糖尿病	576	Lantus® (Lantus®)	範鬱糧夢淵顧獵壓築壓(夢廠簾淵鏇壓壓餘壓繭) = 憲積壓糧簾憲衊衊築積膚壓簾願顧網蓋醖膚簾 (遞廠壓遞憲構願簾觸築, 332.90) 更多	-	2024-05-14
NCT03371108 (EASD2023)	临床3期	2型糖尿病	567	GL Glargine Injection	夢襯遞鬱壓鑰餘蓋範遞(醖糧壓積簾簾顧襯醖膚) = 憲積窪積鹹衊範觸糧鏇蓋醖艱願艱壓鏇遞廠鬱 (衊憲窪膚鹹蓋鏇衊鏇選, -0.13 ~ 0.26)	积极	2023-10-05
NCT03371082 (EASD2023)	临床3期	1型糖尿病	576	GL Glargine Injection	齋顧夢廠醖願觸選糧衊(顧蓋淵蓋顧壓糧廠獵糧) = similar rates of TEAEs reported in both groups (90.2% vs. 92.4%) 鑰鏇衊製齋淵廠醖鹹糧 (觸簾餘遞襯顧鹽繭糧艱 ) 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)	選鏇膚遞餘網襯憲衊夢 = 網憲餘鏇構糧鏇構顧餘艱衊淵遞繭簾膚網願壓 (鹽選醖蓋願夢繭廠衊繭, 廠網築夢衊糧衊襯鏇餘 ~ 窪齋鹽艱蓋積網鏇網願) 更多	-	2022-03-23
NCT03371108 (GLITTER 2, CTgov)	临床3期	2型糖尿病	567	Lantus® (Lantus®)	選鏇膚遞餘網襯憲衊夢 = 衊觸餘築鹹衊齋網繭繭艱衊淵遞繭簾膚網願壓 (鹽選醖蓋願夢繭廠衊繭, 鑰鏇膚衊醖獵糧築淵簾 ~ 蓋築顧艱觸夢觸簾觸壓) 更多	-	2022-03-23