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年在國內獲批上市;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,將按照國家藥品註冊的相關規定和要求組織實施“重組全人源抗PCSK9單克隆抗體注射液”的臨牀試驗,待臨牀試驗成功後按程序申報相關產品的生產。若獲批上市,將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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