綠葉製藥(02186.HK)：利斯的明透皮貼劑(多日貼)獲批中國臨牀試驗
格隆匯9月1日丨綠葉製藥(02186.HK)宣佈，集團用於治療老年性痴呆的在研新藥利斯的明透皮貼劑(多日貼)(LY03013)已獲中國國家藥品監督管理局藥品審評中心(“CDE”)批准啟動臨牀試驗。利斯的明透皮貼劑(多日貼)為針對中樞神經系統疾病的重點產品，由公司德國子公司Luye Pharma AG的透皮貼劑研發平台開發，該產品及其製劑工藝受到多個專利的全球保護。
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、歐盟和日本良好製造規範(GMP)檢查。Luye Pharma AG生產的利斯的明透皮貼劑(單日貼)已在全球20餘國獲批上市，包括美國和歐洲的一些國家，並且是中國首個按質量和療效一致性評價審評要求獲批上市的透皮貼劑產品。相比單日貼，利斯的明透皮貼劑(多日貼)一週給藥兩次，減少了給藥頻率，能夠有效提高患者的用藥依從性，減輕看護人員照料負擔的同時降低社會經濟負擔。
此前，利斯的明透皮貼劑(多日貼)的上市申請已獲德國、英國、西班牙、義大利、葡萄牙、盧森堡、希臘7個歐洲國家正式受理，相關審評工作已在順利開展中。除歐洲和中國外，公司亦準備在美國、日本及其他國家註冊該產品。
除利斯的明透皮貼劑(多日貼)外，集團還有多箇中樞神經系統的在研項目，同步在中國及海外市場進行開發，如LY03004(關於精神分裂症和雙相情感障礙)、LY03003(關於帕金森氏症)、LY03005(關於抑鬱症)、LY03010(關於精神分裂症和分裂情感性障礙的治療)、LY03012(關於慢性疼痛)和LY03014(關於手術後中到重度疼痛和癌性爆發痛)等項目。上述在研產品在中國、美國、歐洲和日本等戰略市場註冊進展良好，未來將在這些國家上市並進一步擴展到全球市場。
公司表示，隨着全球老齡化趨勢的推進，董事會相信，利斯的明透皮貼劑(多日貼)未來會有良好的市場前景，並將豐富集團的未來產品組合。
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