Application for listing of new drug by Yousse Bisetozhu mono anti-drug approved by the State Drug Administration

Recently, The application for the listing of the new drug(http://(JXSS1800003) submitted by Eusspryto in China for the treatment of moderate to severe rheumatoid arthritis (RA) was approved by the State Drug Administrationabout the seto-bead mono-anti-
Setozumab (trade name: Cimzia) is the only anti-tumor necrosis factor alpha (TNF-alpha) without fc domain, polyglycol-modifieddrug(http://, has a very high affinity for human TNF-alpha, and is able to selectively moderate the pathophysiological effect sedative of TNF-alphaSetuzumac was approved for the market on April 22, 2008 by theFDA(http://, and on October 1, 2009, the EMA approved the listing and continues to expand indications, currently covering a wide range of inflammatory diseases: rheumatoid arthritis, psoriasis arthritis, strong spinal inflammation, spinal arthritis, and Crohn's diseaseAt the end of March this year, Cimzia was approved by the U.SFDA for the treatment of adult patients with active non-radiative axial spinal arthritis (nr-axSpA) with inflammatory signsThis approval makes Cimzia the first and only fda-approved drug to treat nr-axSpAOn March 30, 2018, UCBcompany(http://submitted the anti-inflammatory drug Cimzia for the treatment of moderate to severe rheumatoid arthritis (RA) imported drug license (IDL) to obtain the drug review center,the drug(http://named Peselizumac mono-injectionOn June 5, 2018, innovative drugs with clear therapeutic advantages were included in the priority review process and were finally approved for market release in July 2019The listing application is based on positive data from 2 Phase III clinical studies (RAPID-C, RAPID-C OLE) conducted in RA patients in ChinaThe effectiveness and safety of Cimzia and MTX combination therapy were assessed in adult patients who had previously received under-relief treatment for methotrexate (MTX) in moderate to severe RAThe results showed that combined drug use significantly reduced RA symptoms and signs compared to MTX single-drug therapy