"Ambroxol", a new heavyweight drug of Haizheng pharmaceutical industry, is expected to be approved within 1-2 months

According to the information on April 1 on the website of the State Food and Drug Administration (CFDA), the declaration status of the heavyweight new drug "ambano" (recombinant human tumor necrosis factor II receptor antibody fusion protein for injection) of Haizheng Pharmaceutical (600267 SH) changed to "under approval", which means that the drug has been submitted to CFDA for signature and entered the final process of approval, which is expected to be approved within 1-2 months It is worth mentioning that Haizheng pharmaceutical insiders have previously told DZH NEWS that there is no problem from anbainuo itself, and the company is confident of getting the final approval 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 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 is mainly engaged in antibiotics and anti-tumor drug APIs, and 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.