Delving into the Latest Updates on Dulaglutide Biosimilar (HEC) with Synapse

Overview

Basic Info

Drug Type

Fc fusion protein, Biosimilar

Synonyms

14028, HEC-14028, HEC14028

Target

GLP-1R

Action

agonists

Mechanism

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

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Diabetes Mellitus, Type 2

Originator Organization

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Active Organization-

Inactive Organization

Sunshine Lake Pharma Co., Ltd.

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Start Date31 May 2022

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

CTR20220954

/ CompletedPhase 1

一项在健康受试者中比较14028注射液与度拉糖肽注射液（度易达®）药代动力学特征、安全性和免疫原性的单中心、随机、开放、单剂量、平行对照的I期临床研究

[Translation] A single-center, randomized, open-label, single-dose, parallel-controlled Phase I clinical study comparing the pharmacokinetic characteristics, safety, and immunogenicity of 14028 injection and dulaglutide injection (Duida®) in healthy subjects

以礼来公司在中国上市的度拉糖肽注射液（度易达®）为对照药品，评价单次皮下注射东莞市东阳光生物药研发有限公司提供的14028注射液在健康成年男性受试者中的药代动力学特点，并比较试验药物与对照药品的药代动力学相似性。

[Translation]

Using dulaglutide injection (Duida®) marketed in China by Eli Lilly as the control drug, the pharmacokinetic characteristics of a single subcutaneous injection of 14028 injection provided by Dongguan East Sunshine Biopharmaceutical R&D Co., Ltd. in healthy adult male subjects were evaluated, and the pharmacokinetic similarity of the test drug and the control drug was compared.

Start Date25 May 2022

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

100 Clinical Results associated with Dulaglutide Biosimilar (HEC)

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100 Translational Medicine associated with Dulaglutide Biosimilar (HEC)

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100 Patents (Medical) associated with Dulaglutide Biosimilar (HEC)

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100 Deals associated with Dulaglutide Biosimilar (HEC)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BJ05	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	China	Sunshine Lake Pharma Co., Ltd.	31 May 2022

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Clinical Result

Indication

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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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