Last update 24 Jun 2024
Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)
Last update 24 Jun 2024
Overview
Basic Info
Drug Type Biosimilar, Hormone |
Synonyms Insulin glargine biosimilar, Recombinant Insulin Glargine, Recombinant Lispro Insulin + [4] |
Target |
Mechanism INSR agonists(Insulin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (10 May 2005), |
Regulation- |
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Gene Sequence
Sequence Code 4851
The sequence is quoted from: *****
Sequence Code 31960
The sequence is quoted from: *****
Related
5
Clinical Trials associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)单中心、随机、双盲、单剂量、两制剂、两序列、四周期重复交叉设计对照评价甘李甘精胰岛素注射液（3ml：900单位/支）与来优时®TOUJEO在健康受试者中的
生物等效性和安全性研究
[Translation] A single-center, randomized, double-blind, single-dose, two-formulation, two-sequence, four-period repeated crossover design to evaluate the bioequivalence and safety of insulin glargine injection (3ml: 900 units/vial) and Leus® TOUJEO in healthy subjects
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
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
100 Clinical Results associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)
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100 Translational Medicine associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)
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100 Patents (Medical) associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)
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12
Literatures (Medical) associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)01 Dec 2023Diabetes, 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
Author: Lu, Jia ; Zijlstra, Eric ; Chen, Wei ; Li, Longling ; Heise, Tim ; Xie, Tian ; Plum-Mörschel, Leona ; 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.
01 May 2019Advances in therapyQ3 · MEDICINE
A Propensity Score Matched Comparison of Brand and Biosimilar Basal Insulin in Non-Critical Hospitalized Patients with Type 2 Diabetes Mellitus
Q3 · MEDICINE
Article
Author: 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.
01 Feb 2018Journal of endocrinological investigationQ2 · MEDICINE
A comparison of clinical efficacy and economic value in Basalin- and Lantus-treated patients with type 2 diabetes using continuous glucose monitoring system
Q2 · MEDICINE
Article
Author: Yin, G P ; Su, X F ; Xu, X H ; Li, H Q ; Liu, B L ; Jing, T ; Sun, R ; Lu, C F ; Ye, L ; Wang, J ; Lee, K O ; Ma, J H ; Li, F F
AIM:
To determine the clinical non-inferiority of recombinant glargine-Basalin vs glargine-Lantus, in treatment of type 2 diabetes mellitus (T2DM) using continuous glucose monitoring system (CGMS).
METHODS:
One hundred patients with T2DM were recruited. They were either regularly taking Basalin (Basalin group) or Lantus (Lantus group) (n = 50 each). CGMS was employed to real-time monitor blood glucose profile for 4 days (from day 1 to day 5). To exclude the effect of patient background, the study design was to have a blinded crossover from glargine-Basalin to glargine-Lantus on day 3, and vice versa. 24-hour mean blood glucose (24hMBG), 24-hour standard deviation of blood glucose (24hSDBG), 24-hour mean amplitude of glycemic excursion (24hMAGE), and number of glycemic excursion (NGE) every 24 h (24hNGE) were calculated for each glargine from 100 patients.
RESULTS:
No significant difference of 24hMBG, 24hSDBG, 24hMAGE, and 24hNGE (p > 0.05 for all) was found between Basalin and Lantus treatments. The glucose area under the curve and time when blood glucose was below 3.9 mmol/L, between 3.9 and 10.0 mmol/L, or above 10.0 mmol/L were similar between Basalin and Lantus treatment. The frequency of hypoglycemic episodes was also similar. However, the mean cost of Basalin was only 72% of Lantus's in one treatment course.
CONCLUSION:
Glargine-Basalin is non-inferior in clinical efficacy compared to glargine-Lantus. In view of the large difference in the cost of glargine-Basalin, it would be much more cost-effective for our patients.
100 Deals associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus | CN | 10 May 2005 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 2 | Phase 3 | US | 31 Oct 2017 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 3 | 576 | (Gan & Lee Insulin Glargine Injection) | shrfrtovrj(cagyrtrxyh) = yowqopabdc naojhhxldi (qflcfqnwkq, fbrymmowrp - gzcveqbkon) View more | - | 14 May 2024 | ||
(Lantus®) | shrfrtovrj(cagyrtrxyh) = hcwxbbtqdi naojhhxldi (qflcfqnwkq, vyziaajvsd - dvxpnaqfsd) View more | ||||||
Phase 3 | 567 | GL Glargine Injection | douyxqaeii(szmrggaomo) = nbicyznrjc zmvklggygz (netdvgmqmo, -0.13 to 0.26) | Positive | 05 Oct 2023 | ||
Phase 3 | 576 | GL Glargine Injection | rdkxzrzfkf(wjimysippc) = similar rates of TEAEs reported in both groups (90.2% vs. 92.4%) ygtauxxdxb (mffpuenuqg ) View more | Positive | 05 Oct 2023 | ||
Phase 3 | 567 | (Gan & Lee Insulin Glargine Injection) | nvmkyruqnf(epfvcqerfa) = cxvbtmiwzi ygrctirgjd (dzclhlnnyh, ofiaoipsff - qkagyokbnh) View more | - | 23 Mar 2022 | ||
(Lantus®) | nvmkyruqnf(epfvcqerfa) = hfvuvrqivi ygrctirgjd (dzclhlnnyh, txdynhvkee - ndzfsvistx) View more |
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