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信立泰(002294.SZ):“重組全人源抗PCSK9單克隆抗體注射液”獲臨牀試驗默示許可
格隆匯 12-09 19:24

格隆匯12月9日丨信立泰(002294.SZ)公佈,近日,公司及子公司信立泰(成都)生物技術有限公司、信立泰(蘇州)藥業有限公司申報的“重組全人源抗PCSK9單克隆抗體注射液”獲得國家藥品監督管理局的臨牀試驗默示許可,並將於近期開展臨牀試驗。

全球首個上市的PCSK9抑制劑為Amgen開發的依洛尤單抗(Evolocumab),並於2018在國內獲批上市國內尚無其他PCSK9抑制劑獲批

公司獲得臨牀試驗默示許可後,按照國家藥品註冊的相關規定要求組織實施重組全人源抗PCSK9單克隆抗體注射液”的臨牀試驗,臨牀試驗成功後按程序申報相關產品的生產。獲批上市進一步豐富公司心腦血管領域的創新產品線為患者提供新的用藥選擇

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