Delving into the Latest Updates on Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Insulin glargine biosimilar, Recombinant Insulin Glargine, Recombinant Lispro Insulin

+ [4]

Target

INSR

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus

Inactive Indication

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Originator Organization

Gan & Lee Pharmaceuticals Co., Ltd.

Active Organization

Gan & Lee Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (10 May 2005),

Diabetes Mellitus

Regulation-

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Structure/Sequence

Sequence Code 4851

The sequence is quoted from: *****

Sequence Code 31960

The sequence is quoted from: *****

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。

[Translation]

Primary objective: To compare the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of recombinant insulin glargine injection (3ml: 900 units/vial) produced by Ganli Pharmaceutical Co., Ltd. (test preparation, T) and insulin glargine injection (Lysin® TOUJEO, reference preparation, R) produced by Sanofi-Aventis Pharmaceuticals Co., Ltd. in healthy Chinese male subjects using the euglycemic clamp technique. Secondary objective: To evaluate the safety of insulin glargine injection in healthy Chinese male subjects.

Start Date13 Oct 2021

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

NCT04236895

/ CompletedPhase 1

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)

Start Date10 Jul 2018

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

NCT03371082

/ CompletedPhase 3

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®.

Start Date31 Oct 2017

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

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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14

Literatures (Medical) associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)

01 Jun 2024·Diabetes, Obesity and 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

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

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

01 Dec 2023·Diabetes, Obesity and 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: Andersen, Grit ; Gan, Zhongru ; Plum-Mörschel, Leona ; Li, Longling ; Hao, Chunyue ; Xie, Tian ; He, Anshun ; Zijlstra, Eric ; Lu, Jia ; Chen, Wei ; Heise, Tim

AbstractAimFor 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.MethodsThree 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).ResultsBioequivalence 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.ConclusionGL‐Asp, GL‐Lis and GL‐Gla are bioequivalent to their EU‐ and US‐reference products.

01 May 2019·Advances 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: Zhang, Lei ; Jiang, Jikang ; Dong, Chao ; Gao, Weiguo ; Hu, Xia ; Dong, Yanhu

INTRODUCTIONComparisons 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).METHODSThis 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.RESULTSCompared 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.CONCLUSIONIn a non-critical hospital setting, subcutaneous treatment with Lantus brought significant FBG improvement without increased hypoglycemic risk.

100 Deals associated with Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Gan & Lee Pharmaceuticals Co., Ltd.	10 May 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	NDA/BLA	US	Gan & Lee Pharmaceuticals Co., Ltd.	23 Feb 2023
Diabetes Mellitus, Type 1	Phase 2	DE	Gan & Lee Pharmaceuticals Co., Ltd.	10 Jul 2018
Diabetes Mellitus, Type 2	Phase 2	US	Gan & Lee Pharmaceuticals Co., Ltd.	31 Oct 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03371082 (GLITTER1, CTgov)	Phase 3	Diabetes Mellitus, Type 1	576	Gan & Lee Insulin Glargine Injection (Gan & Lee Insulin Glargine Injection)	ofubaaqsbc(dfkoxbhtku) = nezdkufolc rjroapqnpo (pfpxftnpas, pemnhcjnbd - rlgdllolnh) View more	-	14 May 2024
				Lantus® (Lantus®)	ofubaaqsbc(dfkoxbhtku) = qmsixqvgkp rjroapqnpo (pfpxftnpas, oudhaocbhq - ugplbnrxcs) View more
NCT03371108 (GLITTER 2, CTgov)	Phase 3	Diabetes Mellitus, Type 2	567	Gan & Lee Insulin Glargine Injection (Gan & Lee Insulin Glargine Injection)	fnchgjiwyv(qjojtogycw) = imkpjmxtsm wtxrookhot (drweztcpbi, hwflfgedix - xjbbxxngat) View more	-	23 Mar 2022
				Lantus® (Lantus®)	fnchgjiwyv(qjojtogycw) = bblnthjnep wtxrookhot (drweztcpbi, iylhtoshfu - ibebbjnsdi) View more