主要目的：以原研PEG-G-CSF注射液（Neulasta®，Amgen Europe B.V.）为对照，评价PEG-G-CSF注射液（科兴生物制药股份有限公司）预防化疗后中性粒细胞减少的有效性。次要目的：以原研PEG-G-CSF注射液（Neulasta®，Amgen Europe B.V.）为对照，评价PEG-G-CSF注射液（科兴生物制药股份有限公司）预防化疗后中性粒细胞减少的安全性和免疫原性。

[Translation]

Primary objective: Using the original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) as a control, to evaluate the effectiveness of PEG-G-CSF injection (Sinovac Biotech Co., Ltd.) in preventing neutropenia after chemotherapy. Secondary objective: Using the original PEG-G-CSF injection (Neulasta®, Amgen Europe B.V.) as a control, to evaluate the safety and immunogenicity of PEG-G-CSF injection (Sinovac Biotech Co., Ltd.) in preventing neutropenia after chemotherapy.

Start Date02 Jan 2025

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

NCT06711523

/ Not yet recruitingPhase 3

A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy

To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.) as a positive control.

Start Date31 Dec 2024

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

CTR20230867

/ CompletedPhase 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 Date28 Mar 2023

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

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

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

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

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

R&D Status

10 top R&D records.

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR1900021945 (ASCO2023) Manual	Phase 2	Febrile Neutropenia	70	PEG-rhG-CSF+rhG-CSF (AOB)	frjresacaf(fldvokukff) = uhntwnljhd smwdcdndza (rokgxwufsg ) View more	Positive	31 May 2023
				rhG-CSF+PEG-rhG-CSF (BOA)	frjresacaf(fldvokukff) = dteufauyct smwdcdndza (rokgxwufsg ) View more
EHA2022	Not Applicable	Hematopoietic stem cell transplantation	103	PEG-rhG-CSF	fxvdbffrhu(jnqagasqyf) = lkmcxbeulo fndammufcr (zpodtkxmdy )	Positive	10 Jun 2022
ASCO2020	Not Applicable	Neutropenia	30	PEG-rhG-CSF	dseebuucdz(tfudolnvqk) = zmivtwapii uzuwkanqal (zhxyfabkrn ) View more	Positive	25 May 2020
				PEGylated recombinant human granulocyte stimulating factor (Control)	dseebuucdz(tfudolnvqk) = rtcflpmfqu uzuwkanqal (zhxyfabkrn ) View more
ASCO2020	Not Applicable	Breast Cancer Adjuvant	96	PEG-rhG-CSF	gehovcvvbo(pwvzivmydt) = mswujyizrl ouhyncfvhz (wxnjtjoace ) View more	Positive	25 May 2020
				No PEG-rhG-CSF	(rchrnbhycb) = dkivbzigli iwnudobnbu (unecktmgxc ) View more
ASCO2020	Not Applicable	Lymphoma	178	PEG-rhG-CSF	ftryqcxkhl(ucmnwhksqe) = ctbqnqcgkc ltkwuyiiek (ztktpprrge ) View more	Positive	25 May 2020
				rhG-CSF	ftryqcxkhl(ucmnwhksqe) = cskbombddg ltkwuyiiek (ztktpprrge ) View more
ASCO2019	Not Applicable	Acute Myeloid Leukemia	60	PEG-rhG-CSF	dldkexvfvw(ftsbrvmeec) = shxxmqaemk tiyviphncg (qvqziopxah, (17 - 49)) View more	-	26 May 2019
				rhG-CSF	dldkexvfvw(ftsbrvmeec) = apeleogpea tiyviphncg (qvqziopxah, (19 - 43)) View more

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