Delving into the Latest Updates on Liraglutide (Hybio) with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms-

Target

GLP-1R

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Hybio Pharmaceutical Co.. Ltd.

Active Organization

Hybio Pharmaceutical Co.. Ltd.

Inactive Organization-

License Organization

Hybio Pharmaceutical Co.. Ltd.Hikma Pharmaceuticals USA, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (23 Dec 2024),

Diabetes Mellitus, Type 2

Regulation-

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深圳翰宇药业股份有限公司生产的利拉鲁肽注射液为受试制剂，诺和诺德公司生产的利拉鲁肽注射液（商品名：诺和力）为参比制剂，在二甲双胍治疗3个月以上血糖控制不佳的2型糖尿病患者中进行随机、平行、对照、开放、多次给药PK/PD对比研究，评估药代动力学和药效动力学指标相似性，及安全性。

[Translation]

Liraglutide injection produced by Shenzhen Hanyu Pharmaceutical Co., Ltd. was the test preparation, and liraglutide injection (trade name: Victoza) produced by Novo Nordisk was the reference preparation. A randomized, parallel, controlled, open, multiple-dose PK/PD comparison study was conducted in patients with type 2 diabetes who had poor blood sugar control after metformin treatment for more than 3 months to evaluate the similarity of pharmacokinetic and pharmacodynamic indicators, as well as safety.

Start Date03 Jul 2019

Sponsor / Collaborator

Hybio Pharmaceutical Co.. Ltd.

100 Clinical Results associated with Liraglutide (Hybio)

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100 Translational Medicine associated with Liraglutide (Hybio)

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100 Patents (Medical) associated with Liraglutide (Hybio)

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100 Deals associated with Liraglutide (Hybio)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	Hybio Pharmaceutical Co.. Ltd.	23 Dec 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2018	Not Applicable	-	-	Dulaglutide	whhtqchexs(vnzdqryfzi): OR = 1.76 (95% CI, 1.56 - 1.99) View more	Positive	02 Oct 2018
				Liraglutide

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Deal

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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