Apatinib, a class 1.1 new drug of Hengrui medicine, is expected to be approved within one year after entering the site for inspection
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Last Update: 2020-04-03
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Source: Internet
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Author: User
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According to the information on June 3 on the website of the State Food and Drug Administration (CFDA), apatinib, a 1.1 new drug of Hengrui pharmaceutical, is in the stage of waiting for on-site inspection According to the company's personnel, the results of the expert review meeting of the drug are approved for production Industry insiders expect that in accordance with the new drug approval process, after the on-site inspection, there will be three in one comprehensive review and the signature of the drug administration and other links, with a great probability of approval within the year Apatinib is the first molecular targeted drug for advanced gastric cancer in the world, and it is also the first kind of Hengrui medicine that is expected to be listed in the research and development of new drugs In addition to the indications of gastric cancer declared for production, the company is also carrying out clinical trials for indications of liver cancer According to the Research Report of GF Securities, the market space of apatinib for gastric cancer and liver cancer indications is expected to reach 1 billion yuan It is worth mentioning that at the annual meeting of the American Society of Clinical Oncology (ASCO) on June 2, the phase III study of apatinib in the treatment of advanced gastric cancer was selected into the oral report and excellent papers This is the first time among domestic pharmaceutical companies, according to the company.
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