Haizheng pharmaceutical's heavyweight new drug "ambrano" was not approved as expected

Haizheng pharmaceutical's heavyweight new drug "ambenox" (recombinant human tumor necrosis factor II receptor antibody fusion protein for injection) has not yet received the final approval, but the company is confident of the final approval The above-mentioned person said frankly that the time of drug review is indeed a little long From the perspective of the drug itself, there is no problem The company is confident to get the final approval Taizhou local media reported that ambano is expected to enter production by the end of the month In response, the person said that it would also depend on when the approval was obtained, and it is not certain for the time being 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 2014, the company submitted supplementary materials to the drug administration, and in September, it simultaneously entered the product registration site for inspection and GMP certification in the production workshop In January this year, according to the information on CFDA website, ambaro has completed the on-site inspection of product registration and will be transferred to the drug audit center to carry out the three in one comprehensive review 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.