Recombinant Fc fusion proteins of human follicle-stimulating hormone (hFSH) with in vivo biological activities comparable to those of human follicle-stimulating hormone are disclosed. A recombinant hFSH-Fc fusion protein comprises β subunit of hFSH (hFSH β), CTP, α subunit of hFSH (hFSH α), a flexible peptide linker, and human IgG2 Fc variant (vIgG2Fc). A method is also disclosed to make such fusion proteins at good expression levels. These recombinant hFSH-Fc fusion proteins of the present disclosure exhibit sufficient biological activities and prolonged plasma half-lives, leading to improved pharmacokinetics and pharmacodynamics. Thus, a lower dosage may be used and/or better or different therapeutic efficacies with less side effects may be achieved. A method for the application of the recombinant hFSH-Fc fusion proteins in the treatment and/or prevention of human infertility is also disclosed.
