Delving into the Latest Updates on PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms-

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Neutropenia

Originator Organization

Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.

Active Organization-

Inactive Organization

Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.

Drug Highest PhaseSuspendedPhase 1

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

观察健康受试者接受单次皮下注射聚乙二醇化重组人粒细胞集落刺激因子注射液的安全性，耐受性，评估该药的安全剂量范围，考察本品在健康人的药代动力学和药效学特点，确定健康人体的最大耐受剂量，为本品后期临床研究提供依据。

[Translation]

To observe the safety and tolerability of a single subcutaneous injection of pegylated recombinant human granulocyte colony stimulating factor injection in healthy subjects, evaluate the safe dosage range of the drug, investigate the pharmacokinetic and pharmacodynamic characteristics of this product in healthy subjects, determine the maximum tolerated dose in healthy subjects, and provide a basis for the later clinical research of this product.

Start Date03 Dec 2020

Sponsor / Collaborator

Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.

100 Clinical Results associated with PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

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100 Translational Medicine associated with PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

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100 Patents (Medical) associated with PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

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100 Deals associated with PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Phase 1	China	Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.	03 Dec 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2020	Not Applicable	Non-Small Cell Lung Cancer	77	PEG-rhG-CSF	shezbcrpna(pdbgqgpwag) = jcayemdaxo srchtxoedj (aosnsewejh ) View more	-	19 Sep 2020
				聚乙二醇化重组人粒细胞刺激因子注射液(PEG-rhG-CSF) (Control)	shezbcrpna(pdbgqgpwag) = ojthmrcrdw srchtxoedj (aosnsewejh ) View more

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Translational Medicine

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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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