綠葉製藥(02186.HK)利斯的明透皮貼劑(一週兩次)中國上市許可申請獲受理 用於治療輕、中度阿爾茨海默病的症狀
格隆匯4月12日丨綠葉製藥(02186.HK)宣佈，集團開發的中樞神經治療領域產品利斯的明透皮貼劑(一週兩次)的上市許可申請已獲中國國家藥品監督管理局藥品審評中心受理，用於治療輕、中度阿爾茨海默病的症狀。
阿爾茨海默病已成為全球範圍的一大健康難題。隨着中國人口老齡化趨勢加快，阿爾茨海默病的患病率和患者數量逐年遞增。據統計，2020年中國阿爾茨海默病患者約有900萬，2050年預計達到2,100萬。一方面，阿爾茨海默病患者數量的攀升給家庭、社會帶來沉重的照護和經濟負擔；另一方面，該疾病領域的治療選擇十分有限，利斯的明是目前治療阿爾茨海默病的一線用藥。
利斯的明透皮貼劑(一週兩次)是一週兩次的利斯的明改良貼劑劑型，該產品及其製劑工藝已獲得多項國際專利。該產品由本公司德國子公司Luye Pharma AG的透皮貼劑研發平台開發，Luye Pharma AG是歐洲最大的獨立透皮系統製造商之一，擁有工藝高度複雜、技術壁壘高的透皮製劑製造車間，已通過美國食品藥品監督管理局、歐盟和日本GMP檢查。相比市售的利斯的明透皮貼劑(單日貼)，利斯的明透皮貼劑(一週兩次)減少給藥頻率，簡化用藥管理，同時能夠有效提高患者的用藥依從性。與口服制劑相比，利斯的明透皮貼劑(一週兩次)通過透皮給藥方式，有效降低噁心、嘔吐等胃腸道不良反應的發生率，達到穩態時血藥濃度比口服給藥更平穩，更能使患者獲得足劑量的穩定治療，併為存在吞嚥困難患者提供良好的用藥便捷性。該產品已於2021年在歐洲多國獲得上市許可。
集團相信，利斯的明透皮貼劑(一週兩次)未來會有良好的市場前景。為推動該產品惠及更多中國患者，集團與長春金賽藥業有限責任公司("金賽藥業")於2021年12月達成協議，授予金賽藥業利斯的明透皮貼劑(一週兩次)等產品在中國大陸的商業化權利。
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