首个澳门注册上市创新中药!以岭药业芪防鼻通片添“新身份”|久久综合伊人
7月11日晚,以岭药业发布公告称,该公司控股子公司以岭(澳门)有限公司收到澳门特别行政区政府药物监督管理局(以下简称“澳门药监局”)核准签发的《中成药注册证明书》。
公告显示,芪防鼻通片是澳门药监局批准的第一个中成药创新药,用于治疗持续性变应性鼻炎。其功能主治为:益气固表,健脾通窍。用于持续性变应性鼻炎改善肺脾两虚证,症见喷嚏、流涕、鼻塞,鼻痒,自汗,恶风,神疲乏力,少气懒言,舌淡,苔白,脉浮或脉细弱。以岭药业拥有该药独立完整的知识产权。
资料显示,2025年1月,以岭药业发布公告称芪防鼻通片获国家药品监督管理局批准上市。芪防鼻通片作为中药1.1类创新药,组方基于过敏性鼻炎“肺脾两虚为本、外邪侵袭为标”病机理论化裁,融合经典名方“玉屏风散”与“辛夷散”,并创新加入高良姜、蝉蜕等特色药材,肺脾同调、标本兼治,不仅为过敏性鼻炎患者带来了新的治疗选择,也为中医药在耳鼻喉领域的应用注入了新的活力。
据悉,以岭药业以络病理论创新带动中医药产业化,运用现代高新技术研发创新中药。目前,以岭药业拥有17个专利新药,其中11个为国家医保目录产品,5个为国家基药目录品种,尤其是心脑血管和呼吸系统疾病用药品种处于行业领先地位。在研品种方面,2个中药已申报生产,6个中药处于临床阶段,并有上百个院内制剂作为新药研发的“储备军”。此外,以岭药业申报注册的第一个经典名方品种半夏白术天麻颗粒已获受理。
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