Haizheng pharmaceutical enri generic ambano completed the "three in one review"

According to the review center of the State Food and drug administration, the "three in one review" of the recombinant human tumor necrosis factor receptor antibody fusion protein for injection (acceptance No.: cxss1300016, trade name: ambeno) applied by Haizheng pharmaceutical for production on the market has ended, which means that the first McAb in the A-share market has made significant progress According to the analysis of the insiders, according to the general process, after ambrano's review, the State Food and Drug Administration will then notify the on-site inspection, and ambrano will go further from the listing According to the public information, ambroxol is the enri of Pfizer, which is the world's first all-human and soluble tumor necrosis factor antagonists for the treatment of rheumatoid arthritis and ankylosing spondylitis As early as 2005, CITIC Guojian has already sold enri's generic drug "yisaipu" in the market, and has achieved great success Yisaipu has become the main source of CITIC Guojian's annual average revenue of 400-500 million yuan According to some data, the sales volume of similar foreign original research drugs in 2012 has reached 26.68 billion US dollars From the mechanism of action, anbono of Haizheng pharmaceutical mainly acts on TNF, the key pathogenic factor of rheumatoid arthritis and ankylosing spondylitis, which can fundamentally block the progress of the disease, so as to significantly alleviate the common symptoms such as stiffness, morning stiffness, joint swelling and pain, at the same time, prevent the development of bone destruction, improve joint function, and improve the quality of life of patients Haizheng pharmaceutical once said that the company is currently in the period of business model transformation and upgrading, that is, the transformation from API export business to contract customization business, while the research and development field of preparations will gradually upgrade from chemical generic drugs to biological drugs and innovative drugs It is worth mentioning that the joint venture company of Haizheng pharmaceutical and Pfizer pharmaceutical has developed rapidly in recent years According to the plan of Haizheng pharmaceutical and Pfizer pharmaceutical, Haizheng Pfizer will strive to achieve more than $2 billion in operating revenue by 2020.