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On April 25, the NMPA official website showed that the review status of Roche’s new anti-influenza drug Mabaloxavir Tablets (Xofluza) (acceptance number JXHS2000074/75) was changed to "under approval", which means that this new mechanism of action Innovative anti-influenza drugs are not far from being launched in China.
Xofluza was developed by Shiono Yoshihide, a Japanese pharmaceutical company.
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 flu.
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 a multi-center, randomized, double-blind phase 3 clinical study, the enrolled volunteers were administered Xofluza, oseltamivir, and placebo.
In addition, Xofluza can also target Tamiflu-resistant strains of the avian influenza viruses H5N1 and H7N9.
At present, Xofluza has been approved in many countries and regions around the world, and it is approved in Japan for the treatment of influenza A or B virus infection; in the United States, Singapore, Thailand, Hong Kong and Taiwan, etc.
On March 26, 2020, Roche’s Genentech announced that the U.
According to the Insight database (https://db.
I wonder how the new drug will be priced after it is launched in China? Can you give a more affordable price?
Note: The original text has been deleted
Note: The original text has been deleted