NEW functionally active, highly purified, stable Alpha interferon conjugate with polyethylene glycol, represented by one of positional isomers of PEG-NαH-IFN, with a reduced immunogenicity, with a prolonged biological effect are suitable for medical applications, and immunobiological agent based on ITS

摘要

The invention relates to the field of pharmaceutical industry and medicine, in particular to new PEG-derived interferons, and concerns the creation of a new functionally active, highly purified, stable interferon conjugate with polyethylene glycol with interferon alpha activity, with reduced immunogenicity, with prolonged biological effect, improved pharmacokinetic parameters formulas where: n - integer values from 227 to 10,000, so that the molecular weight of the PEG is approximately 10,000 to 4,000,000 Da; m is an integer ≥ 4; IFN is a natural or recombinant polypeptide with an IFN-alpha activity. The invention also relates to medicinal products containing the claimed conjugate of formula (I), pharmaceutical compositions suitable for the treatment of viral and oncological diseases and diseases accompanied by primary or secondary immunodeficiency states, containing the claimed conjugate PEG-IFN and therapeutically acceptable auxiliary components. The invention relates to the use of a conjugate of formula (I) for the preparation of a drug having antiviral, antiproliferative and immunomodulatory activity, a method of preventing and / or treating diseases involving primary or secondary immunodeficiency states, including the administration of a therapeutically effective amount of a conjugate of formula (I), a container, comprising a pharmaceutical composition, and a kit.