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綠葉製藥(02186.HK)LY03004新藥上市申請收到美國FDA回覆信
格隆匯 01-31 12:23

格隆匯1月31日丨綠葉製藥(02186.HK)公佈,公司收到美國食品藥品監督管理局(FDA)就公司每兩週注射一次的緩釋微球肌肉注射製劑,用於治療精神分裂症及雙相情感障礙一型的產品LY03004的新藥上市申請發出的完整回覆函,要求提供更多的信息並解決原料藥生產場地的檢查問題後才能批准此新藥上市申請。公司將與公司的原料藥合作伙伴和美國FDA密切溝通來解決完整回覆函中提到的所有問題,並迅速的推進這個NDA的批准流程。公司董事對儘快地推進LY03004的FDA上市批准流程有信心。

公司已於2019年3月28日向美國FDA申報其第一個NDA-LY03004,並於2019年5月31號成功通過FDA的受理。該公司位於中國煙台的生產基地於2019年7月以零483成功通過上市批准前檢查,為其第一次美國FDA的現場檢查。在中國,該產品的新藥申請已於2019年11月26日獲中國國家藥品監督管理局藥品審評中心受理,並於2019年12月30日已被納入CDE優先審評程序。

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。雙相情感障礙一型,亦稱為躁狂抑鬱症,為一種腦部疾病導致情緒、能量、活動水平及執行日常工作的能力發生異常變化。

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