Roche's New Oral Suspension Formulation of Baloxavir Marboxil Approved in China for Influenza Treatment

Intelligent Finance APP learned on January 5 that, according to the NMPA official website, Roche (RHHBY.US) Baloxavir Marboxil Dry Suspension has been approved for marketing in China (Acceptance No.: JXHS2200111). Previously, the Baloxavir Marboxil tablet formulation was approved in China in April 2021.Baloxavir marboxil is a new anti-influenza drug, which was initially developed by the Japanese pharmaceutical company Shionogi.In 2016, Roche entered into a cooperation agreement with Shionogi, jointly taking charge of the drug's research and development outside Japan and Taiwan, China. Roche holds the commercial promotion rights in regions other than Japan and Taiwan, China.

It is reported that Baloxavir Marboxil Tablets (trade name: Xofluza) is a single-dose oral drug with a completely new anti-influenza mechanism of action. This drug belongs to the Cap-dependent endonuclease inhibitors, designed to inhibit the CAP cap structure-dependent endonuclease in the influenza virus, which is essential for the replication of the influenza virus. Notably, this drug is the first anti-influenza drug approved in the United States in nearly 20 years and is another significant anti-influenza drug by Roche after Tamiflu (Oseltamivir).

This time, Roche has been approved for marketing in China.Baloxavir Marboxil for SuspensionCompared with tablets, oral suspension may provide a more convenient treatment for children and patients with swallowing difficulties. The oral suspension was approved by the FDA in November 2020.