Roche Submits New Drug Application for Baloxavir Marboxil Oral Suspension in China

Intelligent Finance APP learned that on November 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Roche (RHHBY.US) had submitted a marketing application for baloxavir marboxil dry suspension and received acceptance. It is reported that baloxavir marboxil tablets were once included in the list of urgently needed overseas new drugs for clinical use in China and were officially approved in China in April 2021 for treating patients aged 12 years and above with uncomplicated acute influenza, including those at high risk of influenza complications. The submission of this product’s dry suspension for marketing in China means it has the potential to offer more treatment options for patients. Public information shows that baloxavir marboxil is a "first-in-class" single-dose oral drug and also the first innovative mechanism anti-influenza new drug approved by the U.S. FDA in nearly 20 years.

According to publicly available information from Roche, treatment with baloxavir marboxil can reduce the duration of flu symptoms by more than one day, offering patients a more convenient treatment option. It provides therapeutic benefits for both previously healthy flu patients without underlying conditions and those at high risk of flu-related complications. According to an earlier press release from Roche, the oral suspension may offer a more convenient treatment option for children and individuals with difficulty swallowing compared to the tablet form. Positive results have already been achieved in a Phase 3 clinical study named miniSTONE-2 for the baloxavir marboxil oral suspension.