綠葉製藥(02186.HK):1類新藥LY 03014於中國開始I期臨牀受試者入組
格隆匯3月18日丨綠葉製藥(02186.HK)宣佈,集團1類新藥LPM3480392注射液(“LY 03014”)於中國開始I期臨牀受試者入組。
LY 03014是一種小分子Gi蛋白偏向性MOR激動劑,擬用於手術後的中至重度疼痛和癌性爆發痛的治療。已經完成的非臨牀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、便祕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(心臟安全性的重要指標)。
LY 03014首個I期臨牀試驗是一項在中國健康受試者中開展的隨機、雙盲、安慰劑對照、劑量遞增的臨牀研究,旨在評估單次靜脈輸注LPM3480392注射液在人體中的安全性、耐受性、藥代動力學和藥效動力學特徵。
全球每年超過3億手術患者,80%以上出現術後痛,急性術後疼痛約佔75%。阿片類藥物為中至重度疼痛最常規用藥,是術後痛用藥的金標準。術後疼痛給藥不超過72小時,不存在成癮的擔憂。根據IQIVA資料,鎮痛藥在2019年於中國市場規模達到158.2億元人民幣,從2017年至2019年以17.4%的年複合增長率上升。
集團已在全球上市丁丙諾啡透皮貼劑、芬太尼透皮貼劑等鎮痛藥物;此外,還有口服創新小分子化合物鎮痛藥物LY 03014等多個創新鎮痛藥物在研。
董事會相信,LY 03014將有力豐富集團鎮痛領域的產品線,從而持續推進集團在鎮痛領域的發展。
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