Clinical approval of recombinant human mouse chimeric anti-CD20 monoclonal antibody injection

According to the website of the State Food and drug administration, the approval status of the recombinant human mouse chimeric anti-CD20 monoclonal antibody injection (cxsl1100072) of Haizheng Pharmaceutical Co., Ltd has changed to "in approval" since January 14, and the review conclusion is "clinical approval", indicating that the clinical application of the drug has been approved The drug is a generic of rituxan, a blockbuster product of Roche's monoclonal antibody The main treatment is lymphoma and rheumatoid arthritis This product will lay a good foundation for the continuous improvement of the company's subsequent business performance Rituxan is the first monoclonal antibody approved for clinical treatment of non Hodgkin's lymphoma (NHL) in the world According to the statistics of evaluatepharma, the global pharmaceutical market prediction agency, 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, there are no domestic enterprises to produce the product, and only 5-6 domestic enterprises apply for the clinical application of the product Haizheng pharmaceutical is committed to the research and development of multiple monoclonal antibody drugs, among which ambrano, the first monoclonal antibody drug, is expected to be approved for market in 2014 The approved clinical recombinant human mouse chimeric anti-CD20 monoclonal antibody injection will contribute to the monoclonal antibody industry of Haizheng pharmaceutical At the same time, Haizheng Pharmaceutical Co., Ltd has applied for the clinical application of adalimumab, a heavy drug, in November 2013 With high barriers to entry and significant clinical treatment effect, the McAb drug industry has a very broad market prospect, and it is easy to produce heavy bomb products.