先声药业(02096):玛氘诺沙韦颗粒新药上市申请(NDA)获国家药品监督管理局受理

智通财经
Sep 03

智通财经APP讯,先声药业(02096)发布公告,于2025年9月3日,本集团与嘉兴安帝康生物科技有限公司(安帝康)合作的抗流感药物玛氘诺沙韦颗粒(先林达®)新药上市申请(NDA)获国家药品监督管理局(NMPA)受理,用于治疗 2至11岁儿童无并发症的甲型流感和乙型流感,为中国首个成功完成III期临床并申报上市的针对儿童患者的抗流感病毒创新药。

玛氘诺沙韦是一款cap依赖型核酸内切酶抑制剂。玛氘诺沙韦的作用机制是通过抑制流感病毒复制所必需的cap依赖型核酸内切酶,阻断病毒自身mRNA的转录,从而精准抑制病毒复制。

临床研究显示,玛氘诺沙韦颗粒在儿童患者中安全性良好、症状缓解与病毒清除速度更快、耐药风险更低、具有口服药效不受食物影响、剂型更适合儿科患者等潜在临床优势。

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