綠葉製藥(02186.HK)：LY 03004新藥上市申請被CDE納入優先審評程序
格隆匯12月30日丨綠葉製藥(02186.HK)宣佈，注射用利培酮緩釋微球(“LY03004”)的新藥上市申請獲中國國家藥品監督管理局藥品審評中心(“CDE”)納入優先審評程序。LY03004為用於治療精神分裂症每兩週注射一次的緩釋微球肌肉注射製劑。
此前已在中國和美國完成了關鍵性臨牀研究。2019年5月，FDA已經完成立卷審查並決定受理集團研發的LY03004的新藥申請。於2019年11月，集團位於中國煙台的長效製劑生產基地以零483成功通過FDA上市批准前檢查。
公司認為，LY03004作為一種長效注射藥物，只需每兩週注射一次，可以改善口服抗精神病藥物在精神分裂症患者中普遍存在的用藥依從性，並將簡化精神分裂症的療程。此外，與另一種市售藥物相比，LY03004擁有若干優勢，例如患者接受LY03004首次注射後三週毋須再服用口服制劑，而且比該市售藥物能更快地達到穩態血藥濃度。
精 神分裂症是一種嚴重的精神類疾病，具有中斷思維、影響語言、觀念和自我認知的特徵。據世界衞生組織統計，全球有超過2,100萬人受到精神分裂症的困擾，並且每兩名精神分裂症患者中有一人未接受治療。
集團同時已上市多箇中樞神經系統治療領域產品，包括富馬酸喹硫平片(思瑞康)及富馬酸喹硫平緩釋片、利斯的明透皮貼劑、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。
除LY03004外，集團還有多箇中樞神經系統在研項目，同步在中國及海外市場進行開發，其中在臨牀研究階段的項目包括LY03003(用於帕金森病)、LY03005(用於抑鬱症)、LY03010(用於精神分裂症和分裂情感性障礙的治療)、LY30410(用於中輕度阿茲海默症)和LY03012(用於慢性疼痛)等。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，未來計劃在這些國家上市並進一步擴展到全球市場。
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