健康元药业集团股份有限公司 关于玛帕西沙韦胶囊（壹立康R）获得药品注册证书的公告

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Marbocil Capsules, an innovative antiviral drug for treating influenza in healthy adolescents and adults [1][2]. Drug Registration Details - Drug Name: Marbocil Capsules - English/Latin Name: Pixavir Marboxil Capsules - Dosage Form: Capsule - Specification: 20mg - Registration Classification: Class 1 Chemical Drug - License Holder: Health元药业集团股份有限公司 - Manufacturing Company: 凯莱英生命科学技术(天津)有限公司 - Approval Number: 国药准字H20250070 - Approval Conclusion: The drug meets the registration requirements and has been granted a registration certificate [1]. Drug Development and Clinical Data - Marbocil Capsules are indicated for the treatment of uncomplicated influenza A and B in healthy individuals aged 12 and above, excluding those at high risk for complications [2]. - The approval is based on a Phase III, multi-center, randomized, double-blind study demonstrating the drug's efficacy and safety compared to a placebo [2]. - The drug requires only a single dose for the entire treatment course, significantly improving patient compliance [3]. - In clinical trials, the median time to symptom relief for the treatment group was reduced by 27 hours compared to the placebo group (P<0.0001) [3]. - For patients with influenza B, the median time to symptom relief was shortened by 31 hours (P<0.05) [3]. - In adolescents, the median time to symptom relief was reduced by 61 hours compared to the placebo group (P<0.05) [3]. - The drug shows a lower risk of resistance, with a total incidence of amino acid substitutions related to sensitivity decline being 0% for H1N1, 1.2% for H3N2, and 0% for influenza B [3]. - The safety profile is favorable, with a low incidence of adverse reactions compared to the placebo group [3]. Market Situation - Influenza poses a global public health issue, with seasonal outbreaks causing significant health impacts [5]. - The estimated domestic sales of antiviral drugs for influenza are projected to reach approximately RMB 4.7 billion in 2024 [5]. R&D Investment - The cumulative direct investment in the research and development of Marbocil Capsules is approximately RMB 203.0361 million [4].