PG003
Teduglutide biosimilar
Pipeline
Short bowel syndrome
Teduglutide
Teduglutide
Biosimilar
The only treatment that increases intestinal absorption
Features
Short bowel syndrome treatment that increases digestion and absorption by growing villi
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Increases absorption of body fluids and nutrients through binding to the intestinal GLP-2 receptor
Originator
Teduglutide, a GLP-2 analogue, binds to the GLP-2 receptor on enterocytes and triggers villus growth.The grown villi increase in height and depth, increasing the surface area in contact with food, and the expanded surface area allows for the absorption of greater amounts of body fluids and nutrients.
Mechanism
Teduglutide’s core mechanism of action
Non-clinical study results
The effect of increasing the length of villus was confirmed in ICR mice, and the same efficacy as the originator was confirmed
Normal villi
(G1)
PG003 Low conc.
(G2, 0.025 mg/kg)
PG003 Mid conc.
(G3, 0.05 mg/kg)
PG003 High conc.
(G4, 0.1 mg/kg)
Revestive Low conc.
(G5, 0.025 mg/kg)
Revestive Mid conc.
(G6, 0.05 mg/kg)
Revestive High conc.
(G7, 0.1 mg/kg)
Equivalence analysis results
LC and MS analysis results show more than 99% physicochemical equivalence with the originator.
As a result of cAMP analysis using cell lines expressing GLP-2 receptor, intracellular changes were more than 99% similar when administered in the same manner as the originator.
Teduglutide biosimilar research and development results
As a result of the development of a Teduglutide biosimilar, PEPGENE has completed the development of a biosimilar that is more than 99% similar to the originator