罗氏速福达扩龄获批，适用于1岁及以上流感患者

Core Insights - Roche Pharmaceuticals China announced the approval of its antiviral treatment, Xofluza® (generic name: baloxavir marboxil), by the National Medical Products Administration of China on March 3, 2026, for treating uncomplicated influenza A and B in children aged 1 to under 5 years, including both previously healthy patients and those at high risk for influenza complications [1] Group 1: Product Approvals - On February 13, 2026, Xofluza® tablets were approved for use in adults and children aged 5 and above for uncomplicated influenza A and B, expanding the treatment age range from previously 5 years and older to 1 year and older, thus providing comprehensive coverage for infants, children, and adults [2] - The approval of these new indications is based on results from two studies conducted in children aged 1 to under 12 years, demonstrating the drug's efficacy and safety [2] Group 2: Clinical Research Findings - The MINISTONE-2 study, a global Phase III, randomized, double-blind clinical trial, showed that baloxavir marboxil had good tolerability and efficacy in children aged 1 to 12 years, significantly reducing the time to viral clearance by more than two days compared to the neuraminidase inhibitor oseltamivir (24.2 hours vs. 75.8 hours) with a lower incidence of adverse events [2] - The DRAGONSTONE study, conducted in Chinese patients aged 1 to under 12 years, compared baloxavir marboxil with oseltamivir, showing similar rates of adverse events and no new safety signals [3] Group 3: Influenza Impact - According to the World Health Organization, seasonal influenza can lead to 3 to 5 million cases of severe illness and 290,000 to 650,000 respiratory disease-related deaths globally each year, with children being particularly susceptible, having an infection rate of approximately 20% to 30%, which can rise to about 50% during peak seasons [3]