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港股異動 | 綠葉製藥(2186.HK)高開7% 羅替戈汀微球治療帕金森病中國III期研究成功
格隆匯 07-20 09:24
格隆匯7月20日丨綠葉製藥(2186.HK)高開7%,報2.6港元,總市值92億港元。該公司昨日公佈,該集團在研新藥—注射用羅替戈汀緩釋微球(LY03003)治療帕金森病的中國Ⅲ期臨牀試驗達到預設終點。該研究是一項多中心、隨機、雙盲、安慰劑對照研究,驗證LY03003治療早期帕金森病的有效性和安全性。試驗共納入294例中國早期原發性帕金森病患者,按1:1的比例隨機進入LY03003組或安慰劑組。試驗結果顯示,與安慰劑組相比,LY03003組統一帕金森病評分量表(UPDRS)Ⅱ+Ⅲ評分較基線顯著改善,兩組差異具有統計學意義(P<0.001)。相關次要評價指標兩組亦均具有統計學意義(P<0.001)。在安全性方面,LY03003整體安全耐受性良好,未發生與試驗用藥品相關的嚴重不良事件。上述結果表明,LY03003治療早期原發性帕金森病安全有效,可全面改善帕金森病運動症狀。LY03003為該集團長效緩釋製劑平台開發的重點中樞神經系統在研產品之一,該藥物目前在中國、美國、歐洲和日本市場進行同步開發。該集團計劃在中國、美國、日本、歐洲及其他國家註冊和上市LY03003。同時,該集團還在進一步開發一月一次給藥的注射用羅替戈汀緩釋微球。董事會相信,基於帕金森病未滿足的龐大需求,LY03003未來會有良好的市場前景,並將豐富該集團的未來產品組合。

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