Delving into the Latest Updates on Pegylated human granulocyte colony stimulating factor(Shandong Kexing Bioproducts) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Pegfilgrastim (Shandong Kexing Bioproducts), 升白针, 聚乙二醇化人粒细胞刺激因子（科兴生物制药）

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Target

CSF-3R

Mechanism

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

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesSkin and Musculoskeletal Diseases

Active Indication

Breast CancerChemotherapy-Induced Febrile Neutropenia

Inactive Indication-

Originator Organization

Shandong Kexing Bioproducts Co., Ltd.

Active Organization

Shandong Kexing Bioproducts Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 4190

The sequence is quoted from: *****

主要研究目的：比较国产PEG-G-CSF注射液(科兴生物制药股份有限公司)与原研PEG-G-CSF注射液(Neulasta®，Amgen Europe B.V)通过单次皮下注射给药后在健康受试者中PK/PD的生物相似性。次要研究目的：评价国产PEG-G-CSF注射液与原研PEG-G-CSF注射液(Neulasta®，Amgen Europe B.V)通过单次皮下注射给药后在健康受试者中的安全性及免疫原性。

[Translation]

Primary study objective: To compare the PK/PD biosimilarity of domestic PEG-G-CSF injection (Sinovac Biotech Co., Ltd.) and original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) in healthy subjects after a single subcutaneous injection. Secondary study objective: To evaluate the safety and immunogenicity of domestic PEG-G-CSF injection and original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) in healthy subjects after a single subcutaneous injection.

Start Date28 Mar 2023

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

CTR20223291 / TerminatedPhase 1

国产PEG-G-CSF注射液与原研PEG-G-CSF注射液(Neulasta®)在健康受试者中对比药代动力学、药效动力学、安全性和免疫原性的生物等效性研究。

[Translation] A bioequivalence study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of domestically produced PEG-G-CSF injection with that of the original PEG-G-CSF injection (Neulasta®) in healthy subjects.

主要研究目的：比较国产PEG-G-CSF注射液(科兴生物制药股份有限公司)与原研PEG-G-CSF注射液(Neulasta®，Amgen Europe B.V)通过单次皮下注射给药后在健康受试者中PK/PD的生物相似性。次要研究目的：评价国产PEG-G-CSF注射液与原研PEG-G-CSF注射液(Neulasta®，Amgen Europe B.V)通过单次皮下注射给药后在健康受试者中的安全性及免疫原性。

[Translation]

Primary study objective: To compare the PK/PD biosimilarity of domestic PEG-G-CSF injection (Sinovac Biotech Co., Ltd.) and original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) in healthy subjects after a single subcutaneous injection. Secondary study objective: To evaluate the safety and immunogenicity of domestic PEG-G-CSF injection and original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) in healthy subjects after a single subcutaneous injection.

Start Date01 Feb 2023

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

100 Clinical Results associated with Pegylated human granulocyte colony stimulating factor(Shandong Kexing Bioproducts)

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100 Translational Medicine associated with Pegylated human granulocyte colony stimulating factor(Shandong Kexing Bioproducts)

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100 Patents (Medical) associated with Pegylated human granulocyte colony stimulating factor(Shandong Kexing Bioproducts)

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100 Deals associated with Pegylated human granulocyte colony stimulating factor(Shandong Kexing Bioproducts)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	CN	Shandong Kexing Bioproducts Co., Ltd.	31 Dec 2024
Chemotherapy-Induced Febrile Neutropenia	Phase 3	CN	Shandong Kexing Bioproducts Co., Ltd.	03 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


ChiCTR1900021945 (ASCO2023) Manual	Phase 2	Febrile Neutropenia	70	PEG-rhG-CSF+rhG-CSF (AOB)	fgknssazeh(vtpwvfjtql) = kfkdzunyds lmibspwdnk (culjupgkzs ) View more	Positive	31 May 2023
				rhG-CSF+PEG-rhG-CSF (BOA)	fgknssazeh(vtpwvfjtql) = mwymrblmky lmibspwdnk (culjupgkzs ) View more
EHA2022	Not Applicable	Hematopoietic stem cell transplantation	103	PEG-rhG-CSF	tuqeazjosx(alenwdagjn) = agpavmgotq qbapbasdvr (gdcvkztiws )	Positive	10 Jun 2022
ASCO2019	Not Applicable	Acute Myeloid Leukemia	60	PEG-rhG-CSF	xoocnpixly(xrsfolbvwt) = ejfjoznfyu abugyflxms (stcztdsrno, (17 - 49)) View more	-	26 May 2019
				rhG-CSF	xoocnpixly(xrsfolbvwt) = veeccnvrdu abugyflxms (stcztdsrno, (19 - 43)) View more