Product Name
PANPOTIN(Korea, KSA, Thailand), ERYSAA(Malaysia, Philippines, Myanma, Brunei )
| Competitiveness |
- Development as the world's second biosimilar Epoetin alfa product
- Development first time in Korea in accordance with the EMA EPO biosimilar Guideline
- Comparative evaluation for equivalence to original Eprex® from preclinical study to phase III clinical trials in terms of quality,
safety and efficacy.
: The equivalences in pharmacokinetics, pharmacodynamics and toxicity to original Eprex have been already secured.
- This product shows much better quality equivalence to the original Eprex® than the first biosimilar product, Binocrit®
: The isomer contents of PanGen’s product show closer similarity to the original Eprex® than Binocrit®
- Maximize success rate in clinical trial and concomitant sales by partnerships for the multinational joint phase III clinical trial and the distribution rights.
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Major Functions
and Characteristics |
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Erythropoietin is a glycoprotein hormone produced in the kidneys that regulates the production of RBCs according to the oxygen requirement levels of the body. Thus in the dysfunctional kidneys of chronic renal failure patients, Erythropoietin is not produced resulting in the anemia
- This product is manufactured through genetic recombination technology, and acts on the hematopoietic precursor cells in the bone marrow to produce RBCs by stimulating the proliferation and differentiation of Primitive RBCs.
- The initial dose in CRF patients is 50 IU/kg per dose, 3 times a week, given intravenously.
Adjustment of the number or amount of doses is possible according to the hemoglobin concentration level.
The ideal hemoglobin level is 10-12 g/dL.
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