The present invention relates to a high-affinity anti-
cyclic citrullinated peptide single-chain variable region tetravalent micro-molecule
antibody. The invention proves that an anti-CCP
antibody is not only a serologic marker for RA diagnosis, but also plays an important role in RA
pathogenesis, and provides a test basis for RA
targeted therapy with a citrullinated
antigen as a target. In the present invention, a CCP
epitope is used as a therapeutic target and an
entry point. The research content involves multiple levels at which the CCP may be involved in the RA
pathogenesis, so as to systematically and comprehensively reveal the role of the anti-CCP
antibody in the RA
pathogenesis. The
peptide chain of an anti-CCP- ScFv antibody and a
tetramer antibody with a P53 framework used in the invention are completely humanized sequences, acted on and targeted to an
initiation of the RA pathogenesis and chronic process of
inflammation, so as to have more pertinence. Different from existing downstream
inflammatory response mediators and inflammatory signaling pathway mediators that antagonize the RA pathogenesis, the high-affinity anti-
cyclic citrullinated peptide tetravalent micro-molecule antibody of the invention has more leading and accurate targetability of the target, and has better potential for transformation of technological achievements and prospect for
biopharmaceutical development. In addition, an anti-CCP+RA and an anti-CCP-RA targeted by the high-affinity anti-
cyclic citrullinated peptide tetravalent micro-molecule antibody of the invention may be two different
disease subtypes of the RA, so that the antibody may become a new hope for accurately
targeted therapy for such patients.