Approval for production of "ambrano", a new heavyweight drug of Haizheng pharmaceutical
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Last Update: 2015-04-24
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Source: Internet
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Author: User
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According to the information on CFDA website, the declaration status of "ambano" (recombinant human tumor necrosis factor II receptor antibody fusion protein for injection) of Haizheng Pharmaceutical (600267) has changed to "approved document" Ambroxol is the first McAb drug of Haizheng Pharmaceutical (600267), which completed phase III clinical treatment in 2011 and applied 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 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, with an annual sales amount of more than 8 billion US dollars in the global market Haizheng Pharmaceutical (600267) is mainly engaged in antibiotics and anti-tumor drug APIs It is planning to transform from a single API to a high-end preparation Gene drugs and macromolecular drugs are an important part of the company's transformation.
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