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G-CSF

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Modality

Granulocyte Colony-Stimulating Factor (G-CSF)

Granulocyte colony-stimulating factor (G-CSF, CSF-3) belongs to white cell factors, performs important roles in neutrophil differentiation from hematopoietic stem cells.

Many mechanisms and assays have shown that G-CSF stimulates and regulates the generation of neutrophil progenitors from bone marrow to blood circulation. Recombinant G-CSF is approved for the treatment of neutropenic patients, including Filgrastim and Pegfilgrastim.

Application of G-CSF
Filgrastim

Filgrastim is a recombinant human G-CSF produced by recombinant DNA technology in Escherichia coli (E coli) bacteria. It consists of 175 amino acids with a molecular weight of around 19 kDa. The amino acid sequence of the protein is identical to the natural sequence predicted by human DNA sequence analysis but with the addition of an N-terminal methionine, which is required for expression in E. coli.

Amgen was a pioneer in the development and availability of therapeutic drugs for G-CSF and launched Neupogen in 1991. Currently, biosimilars of Neupogen, including Granix, Nivestim, Leleuco, and Zarxio, have been approved by the U.S. Food and Drug Administration (FDA).

Pegfilgrastim

As a covalent conjugate of recombinant methionyl human G-CSF (same as filgrastim) and PEG, Pegfilgrastim is produced by conjugation 20 kD mPEG molecule with the N-terminal methionyl residue of filgrastim. Filgrastim is obtained from the bacterial fermentation of an engineered E. coli strain.

Pegfilgrastim (Neulasta) was also developed by Amgen. Currently, FDA approved several Neulasta biosimilars, such as Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca, Ziextenzo.

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G-CSF Pipelines

Generic Name

Brand Name/

Alternative Name

Expression System

Indications

Manufacturer

R&D Stage

Filgrastim

Neupogen,

Escherichia coli (E. coli)

Neutropenia

Kyowa Kirin Co., Ltd., Amgen, Inc.

Approval

Filgrastim-AAFI, biosimilar

Nivestym, Nivestim

E. coli

Neutropenia

Hospira, Inc., Pfizer Europe MA EEIG

Approval

Filgrastim-SNDZ, biosimilar

ZARXIO

E. coli

Neutropenia

Sandoz, Inc., Clariant AG, Sandoz GmbH

Approval

TBO-Filgrastim

GRANIX

E. coli

Neutropenia

Sicor Biotech UAB, Teva Pharmaceutical.

Approval

Filgrastim biosimilar

RELEUKO, FILGRASTIM-AYOW

E. coli

Neutropenia, Granulocytopenic Fever

Kashiv Biosciences LLC

Approval

Filgrastim biosimilar

瑞白

E. coli

Neutropenia

Qilu pharmaceutical

Approval

Filgrastim biosimilar

金磊赛强, Scimax, Filgrastim-aafi, Filgrastim-sndz, G-CSF, Tbo-filgrastim

E. coli

Neutropenia

GenSci

Approval

Filgrastim biosimilar

泉升

E. coli

Neutropenia

Quangang Pharma

Approval

Filgrastim biosimilar

保力津

E. coli

Neutropenia

Chengdu Institute of Biological Products

Approval

Recombinant human G-CSF

白特喜

E. coli

Neutropenia

SINOVAC Biotech

Approval

Filgrastim biosimilar

TX-01

Pending update

Neutropenia

Tanvex Biopharma, Inc

Approval

Filgrastim

Accofil

Pending update

Neutropenia

Accord Healthcare SLU

Approval

Filgrastim

Grastofil

Pending update

Neutropenia

Accord Healthcare SLU

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Fresenius Kabi AG

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Biolotus Biotech Ltda.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Center For Molecular Immunology

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Rubin Ltd

Approval

Filgrastim biosimilar

Ficocyte

Pending update

Neutropenia

Nanogen Pharmaceutical Biotechnology JSC

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Zydus Cadila Healthcare Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Emcure Pharmaceuticals Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Fuji Pharma Co., Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Blau Pharmaceuticals

Approval

Filgrastim biosimilar

Pending update

Pending update

Acute myeloid leukemia, Lymphoma, Myelodysplastic syndrome, Neutropenia

Pooyesh Darou Biopharmaceuticals Co.

Approval

Filgrastim biosimilar

Pending update

Pending update

tumor

Chandra Bhagat Pharma Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Neiss Labs Limited

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

PT Kalbe Farma Tbk

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

RPG Life Sciences Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Zuventus Healthcare Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Claris Lifesciences Ltd.

Approval

Filgrastim biosimilar

Fiprima

Pending update

Neutropenia

Eurofarma

Approval

Filgrastim biosimilar

Pending update

Pending update

granulocytopenic fever

Harvest Moon BV

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

International Centre for Genetic Engineering and Biotechnology (ICGEB)

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

AqVida GmbH

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Biocon Biopharmaceuticals Pvt Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Cjsc Generium

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Pharmapark LLC

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Reliance Life Sciences Pvt Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Laboratorios AC Farma SA

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Laboratorios Chalver de Colombia SA

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

RAS Lifesciences Pvt Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Probiomed SA de CV

Approval

Filgrastim biosimilar

Pending update

Pending update

Tumor, Neutropenia

Zenotech Laboratories Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Dr. Reddy's Laboratories Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia, Breast Cancer

Dong-A ST Co., Ltd., Dong-A Pharmaceutical Co., Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

North china pharmaceutical

Approval

Filgrastim biosimilar

特尔津, Teerjin,  FILTIM, rHuG-CSF, Topneuter

Pending update

Neutropenia

Ranbaxy Laboratories, Amoytop

Approval

Filgrastim biosimilar

吉粒芬, Jilifen

Pending update

Neutropenia

Huadong Medicine

Approval

Filgrastim biosimilar

立生素, Li Sheng Su

Pending update

Neutropenia

Beijing Shuanglu

Approval

Filgrastim biosimilar

Mielastra

Pending update

Neutropenia

Abbott Laboratories

Approval

Filgrastim biosimilar

Leuco-Plus 300, Leuco-Plus-300, SBS-6002

Pending update

Neutropenia

Apexcela Co., Ltd.

Approval

Filgrastim biosimilar

Biofigran, Colstim, Granulostim, Neutromax

Pending update

Neutropenia

Biosidus SA

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

CJ CheilJedang Corp.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Elea Spa

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Incepta Pharmaceuticals Ltd.

Approval

Filgrastim biosimilar

Neutrofil

Pending update

Neutropenia

Laboratorio Varifarma SA

Approval

Filgrastim biosimilar

Biofilgran

Pending update

Neutropenia

Landsteiner Scientific SA de CV

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Sedico BV

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Siam Bioscience Co. Ltd.

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Sudershan Biotech Ltd

Approval

Filgrastim biosimilar

Neocyte

Pending update

Neutropenia

unilab AG

Approval

Recombinant human granulocyte stimulating factor

津恤力

E. coli

Neutropenia

CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.

Approval

Recombinant human G-CSF

rial, riyakin

Pending update

Neutropenia

Hapharm

Approval

Recombinant human G-CSF

Jie Xin

Pending update

Neutropenia

Jiangsu Wuzhong

Approval

Recombinant human G-CSF

Ruixuexin

Pending update

Neutropenia

Weiming Xinpengbio

Approval

Recombinant human G-CSF

欣粒生

E. coli

Neutropenia

Sihuan shengwu

Approval

Filgrastim biosimilar

Grasalva

Pending update

Neutropenia

Teva Pharmaceutical Industries Ltd.

Approval

Recombinant human G-CSF

赛格力, SunGran

Pending update

Neutropenia

Sunwaybio

Approval

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Lunan

Submit for approval

Filgrastim biosimilar

Filgrastim biosimilar, GranNEX

Pending update

Neutropenia

MYCENAX

Submit for approval

Filgrastim biosimilar

BK 0023, BK-0023, Filgrastim biosimilar

Pending update

Neutropenia

Bio-Ker s.r.l.

phase III

Filgrastim biosimilar

Filgrastim biosimilar, Neutrogen

Pending update

Neutropenia

Virchow Group

phase III

Filgrastim biosimilar

Pending update

Pending update

Neutropenia

Bio Genomics, Inc.

phase I

Filgrastim biosimilar

MNGX-100, Filgrastim

Pending update

Neutropenia

MenoGenix, Inc.

phase I

MW-05

MW 05

Pending update

Neutropenia

Mabwell

phase III

Pegfilgrastim

Neulasta, Neupopeg, G-Lasta

E. coli

Stem cell mobilization, Reduction of neutral granulocytes, reduction of granulocytes and heating, Infection

Kyowa Kirin, Amgen, Inc.

Approval

Pegfilgrastim biosimilar

STIMUFEND, PEGFILGRASTIM-FPGK

Pending update

Granulocytopenic fever, Infection, Tumor

Fresenius Kabi USA LLC, Fresenius Kabi Deutschland GmbH, Merck Serono SA

Approval

Pegfilgrastim-PBBK biosimilar

FYLNETRA, PEGFILGRASTIM-PBBK

Pending update

Neutropenia

Kashiv Biosciences LLC

Approval

Pegfilgrastim-APGF

Nyvepria

Pending update

Neutropenia, Neutropenic fever, Infection

Pfizer Europe MA EEIG, Hospira, Inc.

Approval

Pegfilgrastim

Grasustek

Pending update

Neutropenia

\"JUTA\" Pharma GmbH

Approval

Pegfilgrastim-Bmez

ZIEXTENZO

Pending update

Neutropenic fever, infection, neutropenia

Sandoz GmbH, Clariant AG, Sandoz, Inc.

Approval

Pegfilgrastim biosimilar

Cegfila

Pending update

Neutropenia

Mundipharma

Approval

Pegfilgrastim

Pelgraz

Pending update

Neutropenia

Accord Healthcare SLU

Approval

Pegfilgrastim-CBQV

UDENYCA

Pending update

Hematopoietic subsyndrome of acute radiation syndrome, Granulocytopenic fever, Infection

Coherus BioSciences, Inc.

Approval

Pegfilgrastim-Jmdb

Fulphila

Pending update

Neutropenia, Neutropenic fever, Infection

Mylan Pharmaceuticals, Inc., MyLan SAS

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Rubin Ltd

Approval

Pegfilgrastim biosimilar

新瑞白

Pending update

Neutropenia

Qilu pharmaceutical

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Dong-A Pharmaceutical Co., Ltd.

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Zydus Cadila Healthcare Ltd.

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Harvest Moon BV

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Dr. Reddy's Laboratories Ltd.

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Apotex, Inc.

Approval

Pegylated recombinant human G-CSF

津优力

Pending update

Neutropenia

CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Beijing Shuanglu

Submit for approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

AMEGA Biotech

Approval

Pegfilgrastim biosimilar

Pegfilgrastim biosimilar, Tinapeg

Pending update

Neutropenia

ATG ( Arya TinaGene) Biopharmaceutical

Approval

Pegfilgrastim biosimilar

PegaGen, Pegylated filgrastim

Pending update

Neutropenia

Cinnagen

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Emcure Pharmaceuticals Ltd.

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Nanogen Pharmaceutical Biotechnology JSC

Approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Union Square Ventures LLC

Submit for approval

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Lunan

phase III

Pegfilgrastim biosimilar

R-TPR-029, Pegfilgrastim biosimilar

Pending update

Neutropenia

Reliance Life Sciences Pvt Ltd.

phase III

Pegfilgrastim ANF

ANF-Rho, PEG G CSF ANF

Pending update

Neutropenia

Prolong Pharmaceuticals LLC

phase II

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

MegaLabs ZAO

phase I

Pegfilgrastim biosimilar

G-CSF/PEG 20K

Pending update

Neutropenia

Bio-Ker s.r.l.

phase I

Pegfilgrastim biosimilar

PEG30-rhG-CSF

Pending update

Neutropenia

PegBio

phase I

Pegfilgrastim biosimilar

Pending update

Pending update

Neutropenia

Ask pharm

phase I

Pegylated human G-CSF

PEG-rhG-CSF, 升白针

Pending update

Neutropenia

Kexing Bio-Pharma

phase I

Pegylated recombinant human G-CSF

Pending update

Pending update

Neutropenia

Ask pharm

phase I

Pegylated recombinant human G-CSF

Pending update

Pending update

Neutropenia

Huadong Medicine

phase III

PEGylated Human G-CSF

申力达

E. coli

Neutropenia

Lunan

Approval

QL-0605

PEG-rhG-CSF

Pending update

Neutropenia

Qilu pharmaceutical

phase I

Pegteograstim

Neurapeg

E. coli

Neutropenia

GC Biopharma (formerly Green Cross Corporation)

Approval

Empegfilgrastim

Pending update

Pending update

Neutropenia

Biocad CJSC, Biocad Medical.

Approval

Eflapegrastim

Eflapegrastim-xnst, 罗夫登, Rolvedon, Rolontis, LAPS-GCSF analog

E. coli

Messor cells reduced sexual heating, Infection, Nymnomic granulocyte reduction, Breast cancer, lymphoma, physical tumor

Spectrum Pharmaceuticals, Hanmi Pharmaceutical.

Approval

Lipegfilgrastim

Lonquex

E. coli

Neutropenia

Teva Pharmaceutical Industries Ltd.

Approval

Nartograstim

genetical recombination

E. coli

Leukocyte reduction, neutral granulocyte decrease

Kyowa Hakko Kirin Pharma, Yakult Honsha.

Approval

Lenograstim (Genetical Recombination)

Granocyte

Pending update

Acute myelin leukemia, head and neck tumor, urinary tract cancer, acute lymphocyte leukemia, decrease in neutrophils

Chugai Pharmaceutical Co., Ltd.

Approval

Benegrastim

Ryzneuta, F-627, CSF-Fc fusion protein

CHO cell

Neutropenia, Fever, Breast cancer, Neutropenic fever, Parkinson's disease

Evive Health LLC, Evive Biotech

Approval

Lenograstim biosimilar

Lenobio, Lenograstim Biosidus, Leumostin

Pending update

Neutropenia

Biosidus SA

Approval

Albumin- G-CSF fusion protein

8MW0511

yeast

Leukopenia

Mabwell

phase III

Albumin- G-CSF fusion protein

Pending update

yeast

Heatic neutral granulocyte reduction caused by chemotherapy

Foremost Group

phase II

BBT-015

PEGylated G-CSF

Pending update

Acute radiation syndrome, decrease in neutral granulocytes

Bolder BioTechnology, Inc.

phase I

Mecapegfilgrastim

艾多

Pending update

Neutropenia

Jiangsu Hengrui Pharmaceuticals

Approval

Y-branched pegylated human G-CSF

Pegfilgrastim, YPEG-filgrastim, YPEG-G-CSF, YPEG-rhG-CSF

Pending update

Neutropenia

Amoytop

Submit for approval

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