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Products

PRODUCTS

Biologics

Project code name

PHA30

Competitiveness
  • Under development as the world first biosimilar product to the Lenograstim
  • Under development in accordance with European G-CSF biosimilar guideline
  • From the initial stage of development, it has been subject to comparative evaluation with the original Lenograstim
  • Outstanding efficacy and high safety over the products manufactured from microbial fermentation (filgrastim)
Major Functions
and Characteristics
  • G-CSF is a growth factor that acts on neutrophil precursor cells in the bone marrow to fortify the function of neutrophils.
    It is a therapeutic protein being used in chemotherapy for a variety of solid tumors, the treatment of neutropenia in immunosuppressive therapy, the treatment of neutropenia in aplastic anemia patients, and the stimulation of neutrophil  proliferation and recruitment of peripheral hematopoietic stem cells during transplantation of bone marrow cells and  hematopoietic stem cells.
  • G-CSF is a hematopoietic growth factor produced by monocytes, fibroblasts, and endothelial cells in the bone marrow,  and increases the phagocytic function of neutrophils in infection and inflammation.
  • Lenograstim is a recombinant glycosylated G-CSF that is produced from Chinese Hamster Ovary cells with a molecular weight of 20 kDa. It has a similar glycosylation form and biological activity with human G-CSF, and is used as an adjuvant chemotherapeutic drug in the treatment of nonmyelogenous malignancies.
  • The dose of lenograstim when being used as an adjuvant is 150 mcg/m2/day (5 mcg/kg/day), and is given subcutaneously beginning from the day after chemotherapy completion.
     bone marrow transplantation, myelodysplastic syndrome (MDS), and aplastic anemia; 2 mcg/kg/day is given subcutaneously or 5 mcg/kg/day is given intravenously for neutropenia due to chemotherapy; and 2 mcg/kg/day is given subcutaneously or intravenously for idiopathic neutropenia.