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綠葉製藥(02186.HK)注射用利培酮緩釋微球(LY03004)新藥申請獲受理
格隆匯 11-26 22:06

格隆匯11月26日丨綠葉製藥(02186.HK)發佈公告,注射用利培酮緩釋微球(LY03004)的新藥申請已獲中國國家藥品監督管理局藥品審評中心受理。該產品為該集團開發的用於治療精神分裂症的每兩週注射一次的緩釋微球肌肉注射製劑。

LY03004此前已在中國完成了40例的單次給藥爬坡人體藥代動力學及安全性試驗和100例的人體生物利用度比對試驗,臨牀結果顯示LY03004具有良好的安全性,在達到穩態後,與另一種市售藥物達到生物等效。2019年5月,美國食品藥品監督管理局已經完成立卷審查並決定受理該集團研發的LY03004的新藥申請。2019年11月,該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PAI)。

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。

據悉,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。

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