綠葉製藥(02186.HK)鎮痛藥獲中國臨床試驗批件
綠葉製藥(02186.HK)公布,集團1類新藥LPM3480392注射液已獲中國國家藥品監督管理局藥品審評中心批准開始臨床試驗。
集團指,LY 03014是一種小分子Gi蛋白偏向性MOR激動劑,擬用於手術後中到重度疼痛和癌性爆發痛的治療。已經完成的藥效動力學和藥代動力學研究顯示,該產品能夠顯著的抑制疼痛,並減少呼吸抑制、便秘和阿片類藥物耐受的發生;已經完成的毒理學研究和心血管系統長時程遙測試驗顯示,該產品亦沒有引起肝臟毒性和心臟QT間期的變化。
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