Joincare(SH:600380) Ge Long Hui A P P·2025-12-11 08:55Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative antiviral drug, Mapasavir Capsules, which is indicated for the treatment of uncomplicated influenza in healthy adolescents and adults aged 12 and above [1][2]. Group 1: Drug Approval and Indications - Mapasavir Capsules (brand name: Yilikang®) is classified as a Class 1 chemical drug and has been granted the registration number H20250070 [1]. - The drug is specifically indicated for the treatment of uncomplicated influenza caused by both influenza A and B viruses, excluding patients at high risk for flu-related complications [1]. Group 2: Clinical Study Results - The approval is based on a Phase III, multi-center, randomized, double-blind study that demonstrated the efficacy and safety of a single oral dose of Mapasavir compared to a placebo in healthy adolescents and adults with uncomplicated influenza [1]. - The study achieved both primary and secondary endpoints, confirming clear clinical benefits [1]. Group 3: Clinical Advantages - Mapasavir Capsules require only a single dose for the entire treatment course, significantly improving patient compliance [2]. - The drug shows good efficacy against both influenza A and B viruses, with a median time to symptom relief reduced by 27 hours compared to the placebo group, which is statistically significant (P < 0.001) [2]. - In adolescents, the median time to symptom relief was shortened by 61 hours compared to the placebo group (P < 0.001) [2]. Group 4: Resistance and Safety Profile - The risk of resistance to Mapasavir is lower, with a total incidence of amino acid substitutions related to decreased sensitivity being 0% for H1N1, 1.2% for H3N2, and 0% for influenza B in the clinical studies [2]. - The safety profile of Mapasavir is favorable, with a low incidence of adverse reactions in the Phase III study, showing comparable or lower rates of overall adverse reactions and those classified by system organ compared to the placebo group [2].