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CSPC Mabaloxavir's first generic drug was reported for listing, and the original research was approved in China in only 2 months

 Last Update: 2021-08-09
 Source: Internet
 Author: User

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On July 1, the official website of CDE showed that CSPC Ouyi submitted and accepted the application for the marketing of the 4 generic generic drug "Mabaloxavir Tablets"

Mabaloxavir is a new anti-influenza drug, originally developed by Japanese pharmaceutical company Shiono Yoshihide

In February 2018, Xofluza was the first to be approved in Japan for the treatment of influenza caused by influenza A and B strains; in October 2018, it was approved by the FDA for the treatment of acute and Simple influenza; in April 2021, it was approved by the NMPA to be listed in China under the trade name Sufuda

Xofluza is a single-dose oral drug with a brand-new anti-influenza mechanism of action.

The currently widely used anti-influenza oral medications are neuraminidase inhibitor antiviral drugs (oseltamivir), which need to be taken twice a day for 5 consecutive days

In addition, Xofluza can also target the Tamiflu resistant strains of the avian influenza viruses H5N1 and H7N9.

According to public data query, Xofluza is priced at a high price abroad, with a price of US$400 for 10 mg/10 tablets/box; currently, the online price has not been queried in China

CSPC started the BE trial in November 2020, and completed the clinical trial at the end of May this year in 199 days

Details of the BE trial of the CSPC "Mabaloxavir Tablets"

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