On November 11, 2021 HanX Biopharmaceuticals reported PCT patent "Method for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life" has been officially authorized by the Japan Patent Office (Press release, HanX Biopharmaceuticals, NOV 11, 2021, View Source [SID1234647314]).
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The present invention discloses a platform technology for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life. This technology can effectively improve the binding affinity of IgG antibodies to FcRn and prolong their serum half-life. Moreover, the binding affinity of the modified IgG antibodies to the corresponding antigen will not be reduced. Based on this patented technology, Hans Bio has independently developed a number of long-acting monoclonal antibody and bispecific antibody projects, including the long-acting anti-human PD-1 monoclonal antibody HX008.
HX008 (also known as "Putelimab") is a humanized anti-PD-1 monoclonal antibody developed by Hans Biotech and its former subsidiary Taizhou Hanzhong Biotech. It uses FcRn modification technology for differentiated design, and transforms the Fc of IgG4 to extend the half-life, reduce the number of dosing, reduce treatment costs, and improve patient drug compliance. The results of Phase I clinical trials show that the half-life of the product is 17-23 days for a single dose, and the half-life can reach 18-38 days after stabilization. Hans Biotech led the pharmaceutical evaluation, preclinical research and development, and early clinical research of the HX008 project. In 2018, Lepu Biotech acquired the controlling stake of Taizhou Hanzhong and obtained the right to market and sell the product.
So far, HX008 has conducted multiple Phase II and Phase III clinical trials. Two of the registration clinical trials: advanced melanoma and multiple advanced solid tumors with MSI-H/dMMR, have been submitted to the NMPA for marketing.