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    Home > Medical News > Medical World News > Application for new indications of zhengdafenghai brain neuroprotective agent accepted

    Application for new indications of zhengdafenghai brain neuroprotective agent accepted

    • Last Update: 2020-02-21
    • Source: Internet
    • Author: User
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    On February 20, China biopharmaceutical Co., Ltd issued a notice that edaravone sodium chloride injection, a brain neuroprotective agent developed by its subsidiary Jiangsu zhengdafenghai Pharmaceutical Co., Ltd (trade name: ibitan), has submitted an application for new indications to the State Food and Drug Administration and has been accepted The application for new indications is ALS In 2018, the sales volume of edaravone terminal of public medical institutions in China exceeded 5 billion yuan, according to the data of minenet In January this year, edaravone sodium chloride injection class 3 generic listing application of Jiangsu zhengdafenghai pharmaceutical, affiliated to China biopharmaceutical, was approved and successfully became the first generic in China The approval of registration according to the new classification is deemed to have passed the consistency evaluation Edaravone sodium chloride injection of the original research pharmaceutical enterprise Tianbian Mitsubishi pharmaceutical was listed in the list of the second batch of clinically urgent overseas new drugs in May 2019, successfully included in the priority review and approval in June, and was approved to enter the Chinese market in July In only about half a year, the first domestic imitation came! On February 20, China biopharmaceutical announced that edaravone sodium chloride injection had submitted an application for new indications to the State Food and Drug Administration and was accepted The application for new indications was als Sales of edaravone in China's public medical institutions (unit: 10000 yuan) According to the data of minenet, in 2018, the sales volume of edaravone terminal in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) exceeded 5 billion yuan The main manufacturers of edaravone injection include Nanjing Xiansheng Dongyuan pharmaceutical, Jilin Boda pharmaceutical, Guorui pharmaceutical, Nanjing Hailing pharmaceutical of Yangtze River, etc there are more than 20 manufacturers, and only one is Jiangsu Zhengda Fenghai The data shows that ALS is an irreversible and fatal motor neuron disease Because of the invasion of motor neurons in the brain, brain stem and cristae medulla, the patients gradually develop muscle weakness and paralysis, gradually lose the ability to speak or even swallow, and finally die due to respiratory failure.
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