Haizheng pharmaceutical "recombinant human mouse chimeric anti-CD20 monoclonal antibody injection" obtained clinical approval

According to the website of the State Food and Drug Administration (CFDA), the approval status of "recombinant human mouse chimeric anti-CD20 monoclonal antibody injection", a clinical heavyweight McAb drug declared by Haizheng pharmaceutical, has changed to "approved pending" The drug is a generic of rituxan, a blockbuster product of Roche's monoclonal antibody, which mainly treats lymphoma and rheumatoid arthritis Rituxan is the world's first monoclonal antibody approved for clinical treatment of non Hodgkin's lymphoma (NHL) According to the statistics of evaluatepharma, a global pharmaceutical market forecasting agency, the global sales of rituxan in 2010-2012 were 5.034 billion US dollars, 6.14 billion US dollars and 7.143 billion US dollars, respectively At present, there are no domestic enterprises to produce the product Apart from Haizheng pharmaceutical, there are only five domestic enterprises applying for the clinical application of the product Haizheng pharmaceutical industry began to distribute monoclonal antibodies in 2006 Up to now, it has declared three heavyweight products, and another two are generic drugs of ambrano and adalimumab Ambrano, the fastest growing one, has declared production in July last year and is expected to be approved this year The McAb industry has high barriers to entry, significant clinical treatment effect, and extremely broad market prospects, which is easy to produce heavy bomb products In order to realize the transformation of the company to the field of McAb, in addition to the products that have been declared, the company has a echelon of reserve products in the future Baihua, chairman of Haizheng pharmaceutical, previously said that McAb is an important part of the company's R & D and one of the driving forces behind the company's subsequent performance