紅日藥業(300026.SZ):注射用鹽酸蘭地洛爾獲得藥物臨牀試驗批件
格隆匯3月21日丨紅日藥業(300026.SZ)公佈,公司於近日收到國家藥品監督管理局下發的藥物臨牀試驗批準通知書(通知書編號:2025LP00794)。根據《中華人民共和國藥品管理法》及有關規定,經國家藥監局審查,公司申報的注射用鹽酸蘭地洛爾符合藥品註冊的有關要求,同意本品開展臨牀試驗。
注射用鹽酸蘭地洛爾是一種新型的超短效腎上腺素β受體阻滯藥,該類藥物由於起效快、代謝快、停藥後β受體阻滯作用消失快,在快速性心律失常的治療中發揮重要且不可替代的作用。
注射用鹽酸蘭地洛爾是歐洲《2020ESC/EACTS心房顫動診斷和管理指南》《2021蘭地洛爾臨牀應用中國專家共識》控制心率推薦用藥,其具有選擇性高(其對β1受體的阻滯作用約爲β2受體的255倍,對β1受體的選擇性爲另一個超短效β受體阻滯藥艾司洛爾的8倍)、起效迅速(給藥後1至6分鐘起效)、半衰期短(約爲4分鐘)、停藥後失效快、對心臟血流動力學影響小、無明顯負性肌力作用等優點。
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