Therapeutic enzyme fusion protein having a novel structure and use thereof

28:

• The enzyme fusion protein of claim 27, wherein the therapeutic enzyme forms a dimer through a non-covalent bond, or the therapeutic enzymes form a dimer in anti-parallel configuration with each other.

29:

• The enzyme fusion protein of claim 27, wherein the enzyme fusion protein has increased stability and reduced binding affinity for lysosome receptors, compared to a therapeutic enzyme to which an immunoglobulin Fc region is not fused.

30:

• The enzyme fusion protein of claim 27, wherein the enzyme is selected from the group consisting of beta-glucosidase, alpha-galactosidase, beta-galactosidase, iduronidase, iduronate-2-sulfatase, galactose-6-sulfatase, acid alpha-glucosidase, acid ceramidase, acid sphingomyelinase, galactocerebrosidase, arylsulfatase A, B, beta-hexosaminidase A, B, heparin N-sulfatase, alpha-D-mannosidase, beta-glucuronidase, N-acetylgalactosamine-6 sulfatase, lysosomal acid lipase, alpha-N-acetyl-glucosaminidase, glucocerebrosidase, butyrylcholinesterase, chitinase, glutamate decarboxylase, imiglucerase, lipase, uricase, platelet-activating factor acetylhydrolase, neutral endopeptidase, and myeloperoxidase.

31:

• The enzyme fusion protein of claim 30, wherein the enzyme is alpha-galactosidase A or beta-galactosidase.

32:

• The enzyme fusion protein of claim 27, wherein the immunoglobulin Fc region has a variation selected from the group consisting of substitution, addition, deletion, modification, and a combination thereof in at least one amino acid of a native immunoglobulin Fc region.

34:

• The enzyme fusion protein of claim 33, wherein no chain exchange occurs in the immunoglobulin Fc region.

36:

• The enzyme fusion protein of claim 27, wherein the immunoglobulin Fc region is in the form of a monomer;
• or the immunoglobulin Fc region consists of a hinge region, a CH2 domain, and a CH3 domain.

38:

• The enzyme fusion protein of claim 27, wherein the immunoglobulin Fc region is aglycosylated.

39:

• The enzyme fusion protein of claim 27, wherein the immunoglobulin Fc region is an Fc fragment derived from IgG, IgA, IgD, IgE, or IgM.

40:

• The enzyme fusion protein of claim 27, wherein the immunoglobulin Fc region is a hybrid of domains having different origins derived from immunoglobulins selected from the group consisting of IgG, IgA, IgD, IgE, and IgM.

41:

• The enzyme fusion protein of claim 40, wherein the immunoglobulin Fc region is an IgG4 Fc region.

42:

• The enzyme fusion protein of claim 41, wherein the hinge region of the IgG4 Fc region is substituted with an IgG1 hinge region.

43:

• The enzyme fusion protein of claim 27, wherein the enzyme fusion protein comprises the amino acid sequence of SEQ ID NO:
• 6.

44:

• A method for preventing or treating a lysosomal storage disorder (LSD) in a subject in need thereof comprising administering an effective amount of the enzyme fusion protein of claim 27 or a composition comprising the enzyme fusion protein to the subject.

45:

• The method of claim 44, wherein the lysosomal storage disorder (LSD) is selected from the group consisting of mucopolysaccharidosis (MPS), glycogen storage disease, sphingolipidosis, Niemann-Pick disease, Fabry's disease, Gaucher disease, Hunter syndrome, and Maroteaux-Lamy syndrome.

46:

• The method of claim 44, wherein the composition reduces the binding affinity of an enzyme for a lysosome receptor.

47:

• An expression vector comprising the polynucleotide encoding the enzyme fusion protein of claim 27.

48:

• A transformant into which the expression vector of claim 47 is introduced.