Delving into the Latest Updates on Insulin degludec/Insulin aspart (Dongguan HEC Biopharmaceutical) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

22011

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Sunshine Lake Pharma Co., Ltd.

Active Organization

Sunshine Lake Pharma Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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以诺和诺德公司研发的德谷门冬双胰岛素注射液（诺和佳®）为对照药品，评价单剂量皮下注射东莞市东阳光生物药研发有限公司提供的德谷门冬双胰岛素注射液（22011）在健康受试者中的药代动力学（PK）和药效学（PD）特征，进而评价德谷门冬双胰岛素注射液（22011）和诺和佳®的生物等效性

[Translation]

To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single subcutaneous injection of insulin degludec (22011) provided by Dongguan Sunshine Biopharmaceuticals R&D Co., Ltd. in healthy subjects, using insulin degludec (22011) developed by Novo Nordisk as the control drug, and then to evaluate the bioequivalence of insulin degludec (22011) and insulin degludec (22011).

Start Date08 Jun 2023

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

[+1]

NCT05802862

/ Not yet recruitingPhase 3

A Multi-center, Randomized, Open, Phase III Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared Efficacy and Safety With Insulin Degludec/Insulin Aspart(Ryzodeg) in Chinese Subjects With Type 2 Diabetes

The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).

Start Date01 May 2023

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

100 Clinical Results associated with Insulin degludec/Insulin aspart (Dongguan HEC Biopharmaceutical)

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100 Translational Medicine associated with Insulin degludec/Insulin aspart (Dongguan HEC Biopharmaceutical)

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100 Patents (Medical) associated with Insulin degludec/Insulin aspart (Dongguan HEC Biopharmaceutical)

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100 Deals associated with Insulin degludec/Insulin aspart (Dongguan HEC Biopharmaceutical)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	-	Sunshine Lake Pharma Co., Ltd.	01 May 2023

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Clinical Result

Indication

Phase

Evaluation

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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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