济川药业1.1类中药创新药小儿便通颗粒上市申请获受理|99久久免费国产精精品
近日,济川药业收到国家药品监督管理局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。小儿便通颗粒来源于名医验方,具有健脾和胃、行气导滞的功效,用于小儿便秘,中医辨证属食积证者。
目前市面上可用于缓解小儿便秘的产品,多用于其他疾病伴发的症状。小儿便通颗粒的出现有望造福更多患儿。
作为国内拥有儿科品种、剂型最多的制药企业之一,济川药业深耕儿科优势领域多年,先后培育了蒲地蓝消炎口服液、同贝®小儿豉翘清热颗粒、健胃消食口服液、黄龙止咳颗粒、盛雪元®蛋白琥珀酸铁口服溶液等品牌产品。同时,公司不断加强上市品种的二次开发、中药新药和高端化药研发,获批了新版《药品注册管理办法》实施以来首个中药改良型新药金同贝®小儿豉翘清热糖浆,成为了国内首家获批敏菲乐®盐酸非索非那定干混悬剂和贝罗南®小儿法罗培南钠颗粒的药企,提升了儿科领域的核心竞争力。
此外,济川药业以商业拓展赋能外延式扩张,形成了自主创新和合作研发相结合的研发体系,联合征祥医药开发的流感1类创新药玛硒洛沙韦片,是一款具有全球自主知识产权的新一代靶向流感病毒RNA聚合酶PA抑制剂,全疗程一次用药,上市申请已获国家药监局药品审评中心受理;与天境生物合作开发1类创新药融合蛋白型长效生长激素的生物制品上市申请也已获得国家药品监督管理局受理,每周一次给药,该创新疗法有望为儿童生长激素缺乏症患者带来有效且便捷的治疗方案。
未来,济川药业将继续以“共创幸福精彩的生命体验”为愿景,秉承“引领前沿、创新精品”的研发理念,紧跟医药市场变化,从患者用药需求出发,聚焦中长期发展战略,以科研创新驱动企业高质量、可持续发展,履行好上市医药企业应有的社会责任,为大众健康护航。
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