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綠葉製藥(02186.HK):1類新藥LY 03014完成中國I期臨牀研究
格隆匯 05-10 21:34

格隆匯5月10日丨綠葉製藥(02186.HK)宣佈,集團開發的1類新藥LPM3480392注射液("LY03014")於中國完成I期臨牀研究。LY03014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。

此次完成的I期臨牀為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LY03014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。該項臨牀研究結果顯示:單次輸注LY03014注射液可顯著提高受試者疼痛耐受性,整體安全性良好。

阿片類藥物是治療手術後中到重度疼痛和癌性爆發痛的常規用藥,也是術後痛用藥的金標準。惟現有的阿片類藥物存在潛在的呼吸抑制風險,是導致該類藥物在應用中致死的最主要原因。LY03014作為一種新型鎮痛藥,可實現呼吸抑制和鎮痛作用的分離,有望解決上述未滿足的臨牀需求。LY03014已完成的研究結果顯示:該藥物能顯着抑制手術後疼痛和癌性疼痛,並減少呼吸抑制、便祕和阿片類藥物耐受的發生。此外,已完成的毒理學研究和心血管系統長時程遙測試驗顯示:LY03014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)。

根據IQIVACHPA資料,中國麻醉及鎮痛市場2021年銷售金額達到了388億元人民幣,2017至2021年複合年增長率為13.6%。其中阿片類藥物2021年銷售金額為181億元人民幣,2017至2021年複合年增長率為16.6%,增長速度超過整個麻醉鎮痛領域平均增速。

公司相信,LY03014有潛力解決當前的臨牀需求,在中國具備良好的市場潛力。同時,該產品可與集團的抗腫瘤產品形成豐富的產品組合,並協同腫瘤領域現有的資源與優勢,加速推動公司在該領域佈局和發展。

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