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Nearly April 29, the official website of the State Food and Drug Administration showed that the flu drug Mabaloxavir (English trade name: Xofluza) submitted by Roche in China has been approved by the NMPA to be marketed in China.
Mabaloxavir is a First-in-Class oral antiviral drug that can be effective after one dose.
Mabaloxavir was jointly developed by Shiono Yoshio/Roche.
A phase III clinical study code-named CAPSTONE-2 evaluated the efficacy of mabaloxavir compared with placebo or oseltamivir in the treatment of uncomplicated influenza high-risk adolescents and adult outpatients.
The results of the study showed that the median flu symptom improvement time (TTIIS) of patients in the mabaloxavir group was shorter than that of the oseltamivir group and placebo group, which were 73.
Mabaloxavir has been approved for marketing in Taiwan and Hong Kong, and has been included in the third batch of clinically urgently needed overseas new drugs.
