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
|