The first monoclonal antibody "ambroxol" of Haizheng Pharmaceutical Co., Ltd. has completed on-site inspection

According to the information on January 7 on the website of the State Food and Drug Administration (CFDA), Haizheng pharmaceutical's heavyweight new drug "ambenol" (recombinant human tumor necrosis factor II receptor antibody fusion protein for injection) has completed the on-site inspection of product registration and will soon be transferred to the drug Audit Center for the three in one comprehensive review According to the drug approval process, the drug is expected to be approved for production within half a year Ambroxol is the first McAb drug in Haizheng pharmaceutical industry, which completed phase III clinical treatment in 2011 and declared for production on July 12, 2013 In April last year, the company submitted supplementary materials to the drug administration, and in September, it simultaneously entered the product registration site for inspection and GMP certification of the production workshop At present, GMP certification of production workshop is in the stage of "comprehensive assessment of on-site inspection" According to the public information, ambroxol's original research drug is Pfizer's enri (trade name), which is the world's first all-human soluble tumor necrosis factor antagonist for the treatment of rheumatoid arthritis and ankylosing spondylitis Haizheng pharmaceutical is mainly engaged in antibiotics and anti-tumor drug APIs Previously, the company said that genetic drugs and macromolecular drugs are one of the directions of the company's transformation, and also one of the most important sections of the company In the future, the company will have a large number of resources in the R & D, industrial preparation and marketing to this field.