3月17日,先声药业(02096)发布公告,宣布与嘉兴安帝康生物科技有限公司合作的抗流感药物玛氘诺沙韦片新药上市申请(NDA)已获得国家药品监督管理局(NMPA)受理。
该药物主要用于治疗成人及青少年无并发症的甲型和乙型流感。根据公告,玛氘诺沙韦片具有多项优势,包括无中枢神经系统副作用、口服吸收不受食物影响等,能够在24小时内阻断流感病毒复制。
公告中提到,玛氘诺沙韦的II/III期临床研究显示,所有流感症状的中位缓解时间较安慰剂组改善了26.543%,且该差异具有统计学意义(P<0.0001)。
目前,玛氘诺沙韦儿童颗粒正在进行III期临床试验,旨在评估其在2-11岁流感儿童患者中的安全性和有效性。
(文章来源:财中社)
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