綠葉製藥(02186.HK)：精神疾病新藥LY03010在美開始關鍵性試驗
格隆匯12月21日丨綠葉製藥(02186.HK)宣佈，集團研發的用於精神分裂症和分裂情感性障礙的治療的新藥棕櫚酸帕利哌酮緩釋混懸注射液(“LY03010”)的關鍵臨牀試驗方案已被美國食品藥物管理局(“FDA”)接受，已於美國開始關鍵性臨牀試驗。
據悉，LY03010是一種緩釋混懸注射液，每月給藥一次，以肌肉注射的方式用於精神分裂症和分裂情感性障礙的治療。LY03010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。與另一種市售同類藥物相比，LY03010通過優化初始給藥方案有可能讓患者使用更加方便從而進一步提高用藥依從性。早在IND申報前會議(pre-IND會議)中，FDA已確認可以通過證明多次給藥達到穩態的生物等效性即可支持LY03010的505(b) (2)NDA上市申請。LY03010在美國完成兩項臨牀試驗後，近期向FDA提交了該關鍵臨牀試驗的試驗方案，FDA完成了審評並同意該方案。
而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2100萬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。集團預期，LY03010能被用於改善精神分裂症和╱或分裂情感性障礙患者的用藥依從性，這對於患者、其家人及社會而言，都是一項十分重大的醫療需求。
集團相信，LY03010擁有良好的市場潛力，並將豐富集團的產品組合。
值得注意的是，除LY03010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(精神分裂症和雙相I型情感障礙)、LY03003(帕金森病和中至重度不寧腿綜合症)、LY03005(抑鬱症)、LY30410/LY03013(中輕度阿爾茲海默症)和LY03012(慢性疼痛)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。
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