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綠葉製藥(02186.HK):集團就新藥LY 03009在美國提交臨牀試驗申請
格隆匯 11-15 21:04

格隆匯11月15日丨綠葉製藥(02186.HK)宣佈,集團已就其中樞神經領域新藥LY03009向美國食品藥品監督管理局提交臨牀試驗(IND)申請。LY03009用於治療帕金森病和不寧腿綜合症,由集團基於其長效及緩釋技術平台自主開發。

LY03009為每月給藥一次的微球注射劑,在目標給藥間隔期間能夠穩定維持血漿藥物水平。LY03009具有持續多巴胺能刺激的優點,可對運動併發症起到延緩和治療的作用,能延遲帕金森病治療中左旋多巴的引入。夜間持續有效藥物水平可改善夜間症狀控制和喚醒功能。每月給藥一次的目標給藥間隔更加方便,其降低了患者用藥頻率,簡化治療方案,從而改善用藥依從性和臨牀療效。

除了在美國,該產品也正在澳洲開展I期臨牀試驗,並計劃在中國開展臨牀。

目前,全球範圍內約有1,000多萬名患者飽受帕金森病的困擾;基於龐大的患者羣體和治療需求,2020年全球帕金森用藥市場規模達45.64億美元,預計2026年將以4.68%的複合年均增長率增至59.34億美元。

根據Journal of the National Institutes of Health報導,歐洲和北美的不寧腿綜合症的患病率估計為一般成年人口的1.9至4.6%。

隨着全球老齡化趨勢,董事會相信LY03009未來會有良好的市場前景,並將豐富本集團的未來產品組合。

集團同時已上市多箇中樞神經系統治療領域產品,包括注射用利培酮微球(II)(瑞欣妥®)、富馬酸喹硫平片(思瑞康®)及富馬酸喹硫平緩釋片、利斯的明透皮貼劑及利斯的明多日透皮貼劑、芬太尼透皮貼劑、丁丙諾啡透皮貼劑,覆蓋包括中國、美國、歐洲及日本在內大型醫藥市場以及快速發展的新興市場等全球80個以上國家及地區。

此外,集團還有多個在研項目在中國及海外市場進行同步開發,涵蓋抑鬱症、帕金森病等多種疾病,在中樞神經治療領域形成了豐富的產品組合。

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