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.)

+ [2]

Target

CSF-3R

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

CN (21 Oct 2011),

Neutropenia

Regulation-

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Gene 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

[+11]

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-

ChiCTR2100054095 / RecruitingPhase 4IIT

A randomized controlled clinical research of the safety and efficacy of prophylactic PEG-rhG-CSF 24 hours after chemotherapy in breast cancer patients

Start Date09 Dec 2021

Sponsor / Collaborator

Zhujiang Hospital of Southern Medical University

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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53

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

01 Aug 2024·INTERNATIONAL JOURNAL OF HEMATOLOGY

A case of acute lung injury in a peripheral blood stem cell donor mobilized with pegylated recombinant human granulocyte colony-stimulating factor

Article

Author: Zheng, Zhong-Zheng ; Zhang, Xue-Juan ; Zhang, Ding-Song ; Wang, San-Bin ; Liu, Lin

Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) has been introduced for the mobilization of peripheral blood stem cells (PBSCs). However, no cases of acute lung injury (ALI) in healthy donors have been reported, and the underlying mechanisms remain poorly understood. We first reported a case of ALI caused by PEG-rhG-CSF in a healthy Chinese donor, characterized by hemoptysis, hypoxemia, and patchy shadows. Ultimately, hormone administration, planned PBSC collection, leukocyte debridement, and planned PBSC collection resulted in active control of the donor's ALI. The donor's symptoms improved without any adverse effects, and the PBSC collection proceeded without incident. Over time, the lung lesion was gradually absorbed and eventually returned to normal. PEG-rhG-CSF may contribute to ALI in healthy donors via mechanisms involving neutrophil aggregation, adhesion, and the release of inflammatory mediators in the lung. This case report examines the clinical manifestations, treatment, and mechanism of lung injury induced by PEG-rhG-CSF-mobilized PBSCs.

01 Jul 2024·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: Li, Jia ; Bai, Ou ; Du, Beibei ; Zhao, Yangzhi ; Guo, Wei ; Wang, Xingtong ; Li, Junna

BACKGROUND:

The 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.

METHODS:

107 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.

RESULTS:

The 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.

CONCLUSIONS:

Compared 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 Jun 2024·Heliyon

Analysis of a lung cancer case with transient pseudo hypoglycemia after PEG-rhG-CSF treatment

Article

Author: Liu, Lixing ; Qi, Shuya

Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is an effective treatment for chemotherapy-induced neutropenia. However, it can also induce various adverse effects, including fever, bone pain, and other discomforts arising from the abnormal proliferation of blood cells. This study presents an analysis of a case involving a middle-aged patient with small cell lung cancer who exhibited transiently low blood glucose levels without experiencing any symptoms of hypoglycemia following PEG-rhG-CSF treatment. After thorough evaluation by clinicians and pharmacists, the condition was diagnosed as pseudohyperglycemia, a phenomenon distinct from true hyperglycemia. The article provides a pharmaceutical perspective on the contributing factors, mechanisms, and management strategies for pseudohypoglycemia, offering valuable insights for clinical practice.

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

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	CN	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


CSCO2020	Not Applicable	Neutropenia	337	PEG-rhG-CSF (对照组)	qszhaxgtnf(vdulkyiwgh) = dqgpevwvfm yipedvwoxm (apmbcbmpvk ) View more	-	19 Sep 2020
				PEG-rhG-CSF (治疗A组)	qszhaxgtnf(vdulkyiwgh) = ukkqqgviop yipedvwoxm (apmbcbmpvk ) View more
ASCO2020	Not Applicable	Breast Cancer Adjuvant	96	PEG-rhG-CSF	klnauaesyw(gnieulyxtm) = cmrljljawx dvccxehonj (xtopwhxmsa ) View more	Positive	25 May 2020
				No PEG-rhG-CSF	vzitppvsrr(gdkpaxcvtd) = qbziqwqlby dusvyrhglc (fggvaoidbv ) View more