健康元:流感创新药玛帕西沙韦胶囊(壹立康)上市 可实现一次口服治疗

Core Viewpoint - Health元 announced the approval of its innovative drug, Marpasisavir Capsules (Yilikan®), for domestic market, offering a new experience in flu treatment with a single oral dose for complete therapy [2] Group 1: Drug Development and Approval - The drug was developed in just two years, significantly shorter than the typical 6-8 years for global flu drug development [2] - The rapid development was facilitated by the company's AI-assisted drug design platform, which optimized structure, predicted enzyme activity, and ensured cross-strain coverage [2] - Health元 has built a strong CMC (Chemistry, Manufacturing, and Control) capability over ten years, enabling a streamlined process from small-scale trials to large-scale production in less than half the industry average time [2] Group 2: Clinical Efficacy and Safety - In phase III clinical trials, the median time for symptom relief in the Yilikan® group was significantly shorter than that of the placebo group, with a difference of -27.0 hours (P<0.0001) [3] - Particularly in patients with type B influenza, the Yilikan® group showed a statistically significant improvement with a symptom relief time difference of -31.0 hours (p<0.05) [3] - The drug demonstrated good efficacy in adolescents, with no serious adverse events reported, indicating stable safety performance [3] - Yilikan® maintains clear efficacy against both type A and type B influenza, requiring only a single oral dose and unaffected by food intake, enhancing treatment convenience and compliance [3]