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天大藥業(00455.HK):"注射用尼可地爾"獲藥品註冊證書
格隆匯 05-16 16:36

格隆匯5月16日丨天大藥業(00455.HK)公佈,公司全資附屬公司雲南藥業獲得中華人民共和國國家藥品監督管理局簽發的關於「注射用尼可地爾」的藥品註冊證書。

該產品主要成份為尼可地爾,為凍乾粉針劑型,其適應症主要為不穩定型心絞痛等急性冠狀動脈綜合症。尼可地爾是冠狀動脈微血管心絞痛的一線用藥,能夠有效擴張冠狀動脈,起效速度快,已被納入《冠心病合理用藥指南(第2版)》、《非ST段抬高型急性冠狀動脈綜合症診斷和治療指南》、《ST段抬高型心肌梗死基層合理用藥指南》等多個治療指南。

該產品按化學藥品3類註冊申報,獲得藥品註冊證書後視同通過一致性評價。該藥品獲批將進一步豐富和完善公司產品組合,強化公司在心腦血管領域的優勢。經過數年的研發投入和積累,公司研發已經進入收成期,包含注射用尼可地爾在內,2024年及2025年預計共7個新品種上市,為未來穩健發展打下堅實基礎。

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