Delving into the Latest Updates on Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Jinyouli, PEG-rhG-CSF, Pegfilgrastim Biosimilar (CSPC Pharmaceutical Group Ltd.)

+ [4]

Target

CSF-3R

Action

agonists

Mechanism

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

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Neutropenia

Inactive Indication-

Originator Organization

CSPC Pharmaceutical Group Ltd.

Active Organization

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (21 Oct 2011),

Neutropenia

Regulation-

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10^6/kg).

Start Date01 Aug 2024

Sponsor / Collaborator

Lishui Central Hospital

[+10]

ChiCTR2400087321

/ SuspendedPhase 3IIT

99Tcm-Sulfur Colloid SPECT/CT defined active Bone Marrow Protection combined with Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor Protection for the prevention of Severe neutropenia induced by concurrent chemoradiotherapy in locally advanced cervical cancer

Start Date31 Jul 2024

Sponsor / Collaborator-

ChiCTR2400094635

/ CompletedEarly Phase 1IIT

The Efficacy and Safety of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor or Placebo Combined with Camrelizumab, Paclitaxel and Platinum-based Chemotherapy in the First-line Treatment of Advanced Squamous Cell Carcinoma of the Lung: A Phase II Randomized Controlled Trial

Start Date01 Jun 2022

Sponsor / Collaborator-

100 Clinical Results associated with Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.)

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100 Translational Medicine associated with Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.)

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100 Patents (Medical) associated with Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.)

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58

Literatures (Medical) associated with Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.)

01 Feb 2025·JTO Clinical and Research Reports

Impact of Prophylactic Use of PEG-rhG-CSF on First-Line Immunochemotherapy in Advanced NSCLC: A Cohort Study

Article

Author: Tian, Yuan ; Huang, Letian ; Han, Chengbo ; Sun, Li ; Zhang, Shuling ; Ma, Jietao

IntroductionThis study aimed to assess the impact of prophylactic use of PEG-rhG-CSF on first-line immunochemotherapy in advanced NSCLC.MethodsA cohort of patients with advanced NSCLC who received first-line immunochemotherapy at Shengjing Hospital of China Medical University between January 2019 and July 2024 was selected for this study. Patients were divided into the following two groups: a treatment group that received prophylactic PEG-rhG-CSF (≥1 cycle) 48 hours after immunochemotherapy and a control group that did not receive PEG-rhG-CSF. The primary end points were progression-free survival (PFS), overall survival (OS), overall response rate, and safety. A propensity score-matched analysis was performed to reduce potential confounders.ResultsA total of 220 patients were enrolled, with 87 in the treatment group and 133 in the control group. Median PFS was 10.5 months in both the treatment and control groups (p = 0.86), and median OS was 33.9 months in the treatment group versus not reached in the control group (p = 0.71). The overall response rate was 64.4% in the treatment group and 58.6% in the control group (p = 0.40). After propensity score-matched analysis (each group included 78 patients), median PFS was 12.6 months in the treatment group versus 10.5 months in the control group (p = 0.99), and median OS remained 30.3 months in the treatment group versus not reached in the control group (p = 0.85). The treatment group had a reduced incidence of chemotherapy interruptions, any grade of leukopenia, any grade of neutropenia, and grades 3 to 5 neutropenia, without an increase in immune-related adverse events.ConclusionsThe prophylactic use of PEG-rhG-CSF in patients with advanced NSCLC undergoing first-line immunochemotherapy did not compromise efficacy and safety. It reduced chemotherapy interruptions and neutropenia, without increasing immune-related adverse events, thus supporting safe and uninterrupted treatment.

01 Jan 2025·The American Journal of the Medical Sciences

A retrospective study on the efficacy of pegfilgrastim-filgrastim combination regimen in the mobilization for autologous stem cell transplantation in lymphoma patients

Article

Author: Bai, Ou ; Li, Junna ; Wang, Xingtong ; Zhao, Yangzhi ; Du, Beibei ; Li, Jia ; Guo, Wei

BACKGROUNDThe high mobilization failure rate with the mobilization strategy of combining chemotherapy and filgrastim (rhG-CSF) in autologous hematopoietic stem cell transplantation (auto-HSCT) in lymphomas is one of the unresolved issues. Whether the combination of polyethylene glycol filgrastim [pegfilgrastim (PEG-FIL), PEG-rhG-CSF] and filgrastim (FIL) improves the mobilization success rate and the timing of combination therapy has not been studied.METHODS107 lymphoma patients who received auto-HSCT were retrospectively enrolled and divided into groups of PEG+FIL and FIL. The group of PEG+FIL received pegfilgrastim (9 mg) on the third day of the chemotherapy, followed by filgrastim (10 μg/kg/day) based on the counts of peripheral blood stem cells (PBSC). The group of FIL received filgrastim 10 μg /kg/day depending on the number of PBSCs.RESULTSThe incidence of neutropenic fever in the group of PEG+FIL was significantly lower than in the group of FIL. The mean recovery time of leukocytes at autologous stem cell transplantation was significantly shorter in the group of PEG+FIL than in the group of FIL. Compared to the groups of FIL, the group of PEG+FIL had lower hospitalization costs. We found that the combination therapy is more recommended for patients with a bone marrow hematopoietic area of less than 30 %. Filgrastim is best administered 5-6 days after pegfilgrastim administration.CONCLUSIONSCompared to conventional filgrastim mobilization, the combination of pegfilgrastim and filgrastim schedule has high efficacy, non-inferior safety, and superior health economic benefits during auto-HSCT.

01 Jan 2025·Clinical Therapeutics

The Efficacy Research of Prophylactic PEG-rhG-CSF in Preventing Neutropenia in Early-Stage Breast Cancer Patients Treated With Docetaxel-Based Chemotherapy: A Retrospective Analysis

Article

Author: Ning, Junhong ; Zhang, Xiaoqing ; Ding, Weijie ; Zhang, Jin ; Tang, Yongzhe ; Liu, Yamin ; Wang, Jie ; Xing, Xueting

PURPOSEDocetaxel-based chemotherapy regimens (DBRs) are commonly used in the treatment of early-stage breast cancer (EBC). The prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) has been shown to reduce the incidence of neutropenia induced by DBRs. However, the clinical usage of PEG-rhG-CSF in EBC patients undergoing DBRs in China remains unclear.METHODSThis retrospective study was conducted in 137 EBC patients receiving DBRs from September 2022 to February 2024. We compared the incidence of chemotherapy-induced neutropenia (CIN) between patients who was treated with prophylactic PEG-rhG-CSF or not by complete blood counts, evaluating the effectiveness of PEG-rhG-CSF in preventing CIN. Prophylactic PEG-rhG-CSF was given at 100 μg/kg body weight (maximum total dosage of 6 mg) once 24-48 h following chemotherapy. Meanwhile, we also collected basic patient information, the area under time-concentration curve of docetaxel, and liver and kidney function indicators. Multivariate logistic regression and Receiver operating characteristic (ROC) curve analysis were employed to explore independent factors influencing neutropenia.FINDINGSIn this study, 87 of 137 EBC patients were administrated with prophylactic PEG-rhG-CSF, while 50 were not. Compared to patients who did not receive PEG-rhG-CSF, those who received prophylactic injections had a significantly lower incidence of grade 3-4 CIN (20% vs. 4.6%, P < 0.05). Higher body surface area (BSA), lower body mass index (BMI), elevated alanine aminotransferase (ALT), and nonprophylactic use of PEG-rhG-CSF were found to be positively correlated with CIN occurrence. ROC curve analysis indicated an area under the curve of 0.756 for predicting CIN in EBC patients when BSA was 1.66 m², BMI was 24.8 kg/m², and ALT was 41 U/L, with a sensitivity of 73.08% and specificity of 73.87%.IMPLICATIONSProphylactic use of PEG-rhG-CSF significantly reduces the incidence of CIN, particularly grades 3 and 4. BSA, BMI, ALT, and PEG-rhG-CSF prophylaxis are independent influencing factors for the occurrence of neutropenia.

100 Deals associated with Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.)

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External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	China	CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.	21 Oct 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2022	Not Applicable	Esophageal Carcinoma \| Non-Small Cell Lung Cancer \| Uterine Cervical Cancer \| Head and Neck Neoplasms	41	PEG-rhG-CSF	(aavcrccimk) = evmohzurde vhlylztdgt (fyangrskok )	-	21 Sep 2022
CSCO2020	Not Applicable	Neutropenia \| Head and Neck Neoplasms	20	PEG-rhG-CSF	sfypltyxxe(mjxqobkeom) = 发生率20-50% gqxoihpjrm (ajbupdbzzv ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Neutropenia	337	PEG-rhG-CSF (对照组)	mzpkcsfcyi(qycgctqwqg) = fuhhxrwowz tzzieqqxlq (zcpmmkvfib ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Neutropenia	337	PEG-rhG-CSF (治疗A组)	mzpkcsfcyi(qycgctqwqg) = borojnxvek tzzieqqxlq (zcpmmkvfib ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Uterine Cervical Cancer	15	PEG-rhG-CSF	(yxbenkqxlf) = dncpuhbfwv dfbapldoti (khxcqssplt )	-	19 Sep 2020
CSCO2020	Not Applicable	Non-Small Cell Lung Cancer	77	PEG-rhG-CSF	grwsvuslyv(hczdxslinw) = cfuzfhfdxv fxlwtijvrd (hqwyxllcoy ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Non-Small Cell Lung Cancer	77	聚乙二醇化重组人粒细胞刺激因子注射液(PEG-rhG-CSF) (Control)	grwsvuslyv(hczdxslinw) = bqrddeniir fxlwtijvrd (hqwyxllcoy ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Non-Hodgkin Lymphoma	104	PEG-rhG-CSF	zzoxkaekzi(zupezxjtsc) = hgtqyfcqzl leztjdvqgg (rdrawuadbd ) View more	-	19 Sep 2020

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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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