In the treatment of chronic wounds, platelet-derived growth factor (PDGF), specifically its isoform BB (PDGF-BB), is utilized to control the healing process. At the location of damage, active platelets produce PDGF, which attracts and grows mesenchymal stem cells and initiates the process of tissue repair.
Application of PDGF
Becaplermin (Regranex)
The active substance in Regranex gel is a recombinant human platelet-derived growth factor (PDGF), becaplermin, which is discovered for the topical treatment of lower extremity diabetic neuropathic ulcers. Becaplermin is manufactured using recombinant DNA technology in an engineered yeast (Saccharomyces cerevisiae) carrying PDGF B-chain encoding gene. The recombinant PDGF-BB protein is a homodimer consisting of two identical polypeptide chains linked by disulfide bonds, with a molecular weight of approximately 25 kDa. Becaplermin (Regranex) was developed by Smith & Nephew.
Augment
Augment (Injectable) is a substitute for the bone graft, which contains three sections, including recombinant human PDGF-BB.
The first part is made up of particles of a bone-like ceramic material called beta-tricalcium phosphate (beta-TCP); the second part consists of cow hide tissue (bovine collagen); the third part is a genetically engineered human PDGF-BB manufactured in yeast cells. Developed by BioMimetic Therapeutics, augment is FDA-approved for use in arthrodesis and ankle hindfoot in patients who require additional grafting material to replace autografts.
GEM 21S
GEM 21S consists of two sterile components: recombinant, highly pure human PDGF-BB and synthetic beta-tricalcium phosphate (13-TCP) [Ca3(PO4)]. It is a fully synthetic grafting system for bone and periodontal regeneration and was developed by Lynch Biologics.
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for PDGF
Platelet-derived Growth Factor (PDGF) Pipelines
|
Generic Name
|
Brand Name/ Alternative Name
|
Expression System
|
Indications
|
Manufacturer
|
R&D Stage
|
|
Becaplermin
|
Regranex, Becaplermin gel, Gemesis, rhPDGF-BB, RWJ-60235
|
Yeast (Saccharomyces cerevisiae)
|
Lower extremity diabetic neuropathic ulcers
|
Smith & Nephew
|
Approval
|
|
Becaplermin biosimilar
|
Healace, Plermin gel, Recombinant human platelet-derived growth factor
|
Pending update
|
Diabetic foot ulcers
|
Virchow Group
|
Approval
|
|
Becaplermin biosimilar
|
rhPDGF-BB
|
Yeast (Pichia pastoris)
|
Lower extremity diabetic neuropathic ulcers
|
Tasly Pharmaceuticals
|
Phase 3
|
|
Becaplermin biosimilar
|
BC-PDGF-BB, BioChaperone PDGF-BB
|
Pending update
|
Diabetic foot ulcers
|
Adocia SA
|
Phase 3
|
|
TPG gel
|
rhPDGF-BB
|
Yeast
|
Diabetic foot ulcers
|
Huaren shengwu
|
Phase 2
|
|
Periogen
|
rhPDGF and -beta-TCP
|
Pending update
|
Periodontal Bone Defect
|
Virchow Group
|
Phase 3
|
|
GEM 21S
|
Growth-factor Enhanced Matrix, synthetic grafting system
|
Yeast
|
Bone and periodontal regeneration
|
BioMimetic Therapeutics, Lynch Biologics
|
Approval
|
|
Augment
|
Bone graft alternative
|
Yeast
|
arthrodesis and ankle hindfoot that need supplemental graft material
|
BioMimetic Therapeutics
|
Approval
|
Reference:
[1] Galarraga-Vinueza ME, Barootchi S, Nevins ML, Nevins M, Miron RJ, Tavelli L. Twenty-five years of recombinant human growth factors rhPDGF-BB and rhBMP-2 in oral hard and soft tissue regeneration. Periodontol 2000. 2023 Sep 8. doi: 10.1111/prd.12522.
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