Clinical application of the first McAb for class 2 biological products in Shanghai medicine

According to the website of the State Food and Drug Administration (CFDA) on May 14, the "recombinant anti-CD20 humanized monoclonal antibody injection" for class 2 biological products declared by Shanghai Pharmaceutical was accepted, which is the first monoclonal antibody drug declared by the company and wants to take a share in the hot monoclonal antibody field Recombinant anti-CD20 humanized monoclonal antibody is mainly used to treat lymphoma and rheumatoid arthritis It is based on the structure of human mouse chimeric monoclonal antibody rituximab Compared with mouse and human mouse chimeric antibody, the humanized anti-CD20 antibody not only retains or improves the high affinity of variable region, but also reduces the immunogenicity of chimeric antibody So as to reduce the side effects of drugs and improve the clinical treatment effect Rituxan is the world's first monoclonal antibody approved for clinical treatment of non Hodgkin's lymphoma (NHL), according to the global pharmaceutical market forecasting agency e According to the statistics of valuepharma, the global sales of rituxan in 2010-2012 were US $5.034 billion, US $6.14 billion and US $7.143 billion, respectively At present, only the original research varieties have been listed in China, and five generic drugs have been applied for clinical application in China However, the humanized recombinant anti-CD20 humanized monoclonal antibody has no interest of manufacturers, and Shanghai Pharmaceutical has become the first enterprise to declare the clinical application of this product The patent period of the original research enterprise of McAb will come According to the analysis of the Research Report of securities companies, it is estimated that the domestic McAb market will reach 15 billion yuan by 2015 At present, CITIC Guojian, Huashen group, Lizhu group, Fosun Pharmaceutical and other companies of Lansheng Co., Ltd are all in the field of monoclonal antibody Shanghai Pharmaceutical has completed the clinical application of humanized anti-CD20 monoclonal antibody Last year, the company also started to establish its own antibody project The high affinity recombinant human tumor necrosis factor receptor Fc fusion protein developed in cooperation with Fudan Zhangjiang is currently waiting for clinical approval In August last year, it also introduced compound HER2 antibody and launched pre clinical research In the second half of last year, the company also introduced t-dm1 and cd30-dm1, the products under development of antibody coupling drugs, through the acquisition of 100% equity of Shanghai cross-linked drug R & D Co., Ltd.