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綠葉製藥(02186.HK):長效製劑生產基地通過上市批准前檢查
格隆匯 11-04 07:26

格隆匯11月4日丨綠葉製藥(02186.HK)公佈,集團收到美國食品藥品監督管理局(FDA)正式檢查報告,顯示集團位於煙台的長效製劑生產基地以零483成功通過上市批准前檢查(PAI)。這次為期七天的PAI檢查是集團的首次美國FDA現場檢查,關係着集團用於治療精神分裂症及雙相情感障礙一型的每兩週注射一次的緩釋微球肌肉注射製劑—Rykindo®(LY03004)的NDA新藥申請。

公告稱,成功通過PAI檢查是集團重要的里程碑,讓集團離在美國的首次獲批上市目標更近一步,併為美國精神分裂症和I型雙相情感障礙患者提供另一種治療選擇。

公司認為,Rykindo®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,Rykindo®擁有若干優勢,例如患者接受Rykindo®首次注射後只需服用更短的口服制劑,而且比該市售藥物能更快地達到穩態血藥濃度。

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