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恆瑞醫藥(600276.SH):硫酸氫伊伐佈雷定緩釋片獲批臨牀試驗
格隆匯 04-20 18:13

格隆匯 4 月 20日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發關於硫酸氫伊伐佈雷定緩釋片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021119日受理的硫酸氫伊伐佈雷定緩釋片符合藥品註冊的有關要求,同意開展臨牀試驗。

適應症:本品適用於竇性心律且心率≥70/分鐘、伴有心臟收縮功能障礙NYHAII~IV級慢性心力衰竭患者,與標準治療包括β-受體阻滯劑聯合用藥,或者用於禁忌或不能耐受β-受體阻滯劑治療時。

伊伐佈雷定是一種單純的降低心率的藥物,通過選擇性和特異性抑制心臟起If電流而降低心率伊伐佈雷定最初以鹽酸鹽的形式做成片劑,最早於200510月在法國上市,申請公司為法國施維雅,商品名為Procoralan/Corlentor20154月於美國上市,申請公司為美國安進,商品名為Corlanor;於2015年,國家食品藥品監督管理局批准了法國施維雅鹽酸伊伐佈雷定片(商品名:可蘭特)進口。

經查詢,歐洲有同類產品Ivabradine AnpharmIvabradine Accord等已獲批。國內目前僅有Les Laboratoires Servier(施維雅)的鹽酸伊伐佈雷定片上市銷售。公司開發的是晶型單一且穩定的伊伐佈雷定硫酸氫鹽,國內外尚無硫酸氫伊伐佈雷定緩釋片上市銷售。

經查詢,2019年伊伐佈雷定全球銷售額為3.79億美元截至目前,硫酸氫伊伐佈雷定相關項目累計已投入研發費用約5094萬元

根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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