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Products

PRODUCTS

BIOLOGICS

Project code name

PGA40

Competitiveness
  • Under development of world's third B-domain deleted recombinant Factor Ⅷ in the world
  • Developing as a new drug product in compliance with the European Factor VIII Guideline
  • The recombinant Factor VIII product is much safer than the plasma-derived Factor VIII product.
  • Securing the price competitiveness by minimizing the production cost
Major Functions
and Characteristics
  • Factor VIII is produced in human hepatocytes and circulates throughout the body, and is activated when blood coagulation is required.
  • Hemophilia is a hemorrhagic disease due to the deficiency of blood coagulation factors, which consist of factors I through XIII,  and hemophilia occurs when there is a genetic deficiency of any one of these factors. The cause of hemophilia A is a deficiency of Factor VIII, and is known to occur in 1 out of 5,000 male newborns. Hemophilia B occurs when Factor IX is deficient,  and is reported to occur in 1 out of 20,000 male newborns.
  • Hemophilia is treated through replacement of the deficient coagulation factors, and Factor VIII and IX products are being used.
  • In case of antibody production, bypass factors are administered. Methods of administration include on-demand administration,  where the drug is given whenever there is a bleeding episode; and prophylaxis, where deficient coagulation factors are regularly given so that bleeding can be prevented.
  • Recombinant Factor VIII products are appropriate for adults and children, including newborns, and the dose and duration  of administration are decided according to the degree of Factor VIII deficiency, the area and degree of bleeding,  and the patient’s clinical condition.
  • The dosing unit of Factor VIII is indicated as International Units (IU), the WHO international standard of Factor VIII activity. Normally, the prophylactic dose of recombinant Factor VIII is 30 ± 5 IU/kg, 3 times a week.