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GM-CSF

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Modality

Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Granulocyte-macrophage colony-stimulating factor (GM-CSF, CSF-2) and granulocyte colony-stimulating factor (G-CSF, CSF-3) belong to white cell factors (leukocyte growth factor) and perform important roles in neutrophil differentiation of hematopoietic stem cells.

As a hematopoietic growth factor, GM-CSF can promote the proliferation and differentiation of hematopoietic progenitor cells. And recombinant GM-CSF, including Molgramostim and Sargramostim, has received approval for the treatment of neutropenia.

Application of GM-CSF
Molgramostim

Produced using Escherichia coli expression system, molgramostim is a non-glycosylated protein and includes 127 amino acids with isoleucine at position 100 with a molecular weight of 14.5 kDa.

Sargramostim

Produced by recombinant DNA technology in a yeast (Saccharomyces cerevisiae), Sargramostim, is a recombinant human GM-CSF and a glycosylated protein consisting of 127 amino acids. Its amino acid sequence is different from that of human GM-CSF in that the arginine (Arg) at position 23 is replaced by a leucine (Leu).

Sargramostim (Leukine) was developed by Schering and Sanofi and is now marketed by Partner Therapeutics.

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GM-CSF Pipelines

Name

Brand Name/

Alternative Name

Expression System

Indications

Manufacturer

R&D Stage

Sargramostim

LEUKINE

Saccharomyces cerevisiae

Neutropenia

BERLEX LABS, Partner Therapeutics, Inc., Bayer AG

Approval

Sargramostim biosimilar

Pending update

Pending update

Neutropenia

Emcure Pharmaceuticals Ltd.

Approval

Molgramostim

Pending update

Escherichia coli (E. coli)

Neutropenia

Schering-Plough Corp.

Approval

Molgramostim topical gel

金扶宁, 外用凝胶

E. coli

Burn

GenSci

Approval

Molgramostim biosimilar

吉洛因

Pending update

Neutropenia

Institute of Medical Biology

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

bioMérieux SA

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Laboratorios AC Farma SA

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Probiomed SA de CV

Approval

Molgramostim biosimilar

特尔立

Pending update

Neutropenia

Amoytop

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

AMEGA Biotech

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

BioGeneric Pharma SAE

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Blau Pharmaceuticals

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Laboratorios Bioprofarma

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Reliance GeneMedix Ltd.

Approval

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Zenotech Laboratories Ltd.

Approval

Recombinant Human GM-CSF

健白

Pending update

Neutropenia

PKU HealthCare Corp

Approval

Recombinant Human GM-CSF

Gurning

Pending update

Neutropenia

HYBio

Approval

Recombinant Human GM-CSF

Pending update

Pending update

Neutropenia

Guangzhou Baiyunshan

Approval

Recombinant Human GM-CSF

金磊赛源

E. coli

Neutropenia

GenSci

Approval

Recombinant Human GM-CSF

Pending update

Pending update

Neutropenia

Sino Biopharma

Approval

Recombinant Human GM-CSF

Pending update

Pending update

Neutropenia

Changchun Institute of Biological Products

Approval

Recombinant Human GM-CSF

里亚尔

E. coli

Neutropenia

Hapharm

Approval

Recombinant Human GM-CSF

Pending update

Pending update

Neutropenia

Jiangzhong pharmaceutical

Approval

Recombinant Human GM-CSF

尤尼芬

Pending update

Neutropenia

Hainan unipul pharma

Approval

Recombinant Human GM-CSF

华北吉姆欣

Pending update

Neutropenia

North china pharmaceutical

Approval

Molgramostim inhalation

Pending update

Pending update

Neutropenia

Savara, Inc., Savara Pharmaceuticals, Y-mAbs Therapeutics, Inc.

phase III

Molgramostim biosimilar

Pending update

Pending update

Neutropenia

Zhejiang Zhongqi BioPharma

phase II

GX-G3

A recombinant human G-CSF fused to hyFc

Pending update

Heatic neutral granulocyte reduction caused by chemotherapy, Neutropenia

Boryung Corp., Ilkogen, Genexine, Inc.

phase II

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