G-CSF

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.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for G-CSF

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

All Categories

Modality

Granulocyte Colony-Stimulating Factor (G-CSF)

Application of G-CSF

Filgrastim

Pegfilgrastim

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for G-CSF

G-CSF Pipelines

MICROBIAL CDMO

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