Haizheng 1.1 new drug "Haize Mabu" is approved to add new specifications and change production process
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Last Update: 2016-06-29
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Source: Internet
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Author: User
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Haizheng Pharmaceutical Co., Ltd issued a notice on June 28, announcing that it has received the notice of approval opinions on the varieties of raw materials of isapirone and Haize mAb approved and issued by CFDA and the approval documents for clinical trials of Haize mAb tablets As a new drug of Haizheng 1.1, its indication is cholesterol absorption inhibitor, which acts on npc1li, a small intestinal brush border transporter, and inhibits cholesterol absorption in food and liver circulation At present, the global sales volume of the only listed drug ezemeb and its compound preparations in 2015 is about US $5.05 billion, and the sales volume in the Chinese market is US $7.46 million (data source: IMS) On April 30, 2015, Haizheng submitted to the State Food and drug administration an application for registration of change of production process of Haize Mabu API, on June 13, 2015, Haize mAb tablet (specification: 10mg) change of prescription and production process, and on September 6, 2015, Haize mAb tablet increased by 20mg Specification registration application Up to now, the company has invested about 153 million yuan in the drug R & D project.
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