RECOMBINANT HUMAN EPO-Fc FUSION PROTEIN WITH PROLONGED HALF-LIFE AND ENHANCED ERYTHROPOIETIC ACTIVITY

摘要

PROBLEM TO BE SOLVED: To provide EPO (erythropoietin) analogs that have a significantly longer half-life and enhanced erythropoietic activity in vivo but have no increased immunogenic properties.

SOLUTION: The fusion protein having a prolonged half-life in vivo in comparison to naturally occurring or recombinant native human erythropoietin includes: (a) a naturally occurring human erythropoietin molecule having a cysteine residue proximate the C terminal thereof; and (b) an Fc fragment of human IgG including a hinge region wherein the N terminal of the Fc fragment is directly linked to the C terminal of the erythropoietin molecule, the Fc fragment is the same as a naturally occurring Fc fragment except that a cysteine residue located nearest the erythropoietin molecule has mutation substituted by a non-cysteine residue, the first cysteine in the hinge region is spaced at least 17 amino acids apart from the cysteine residue of the erythropoietin molecule.

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