Platelet-derived Growth Factor (PDGF)

Modality

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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Platelet-derived Growth Factor (PDGF)

Modality