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中國生物製藥(01177.HK):精神分裂症治療藥物“鹽酸魯拉西酮片”獲藥品註冊證書
格隆匯 03-14 07:08

格隆匯3月14日丨中國生物製藥(01177.HK)發佈公吿,集團開發的精神分裂症治療藥物“鹽酸魯拉西酮片”(商標名:晴力欣)獲得中國國家藥品監督管理局頒發藥品註冊證書,且視同通過仿製藥質量和療效一致性評價。

根據披露,鹽酸魯拉西酮是一種口服的非典型抗精神病藥物,為5-HT2A受體和多巴胺D2受體拮抗劑。它對 5-HT2A受體和多巴胺D2受體均具有高度親和力;同時,它與5-HT7有較高的親和力,且為5-HT1A 受體的部分拮抗劑。臨牀研究表明,鹽酸魯拉西酮在改善精神分裂症的陽性及陰性症狀和減少不良反應方面具有明顯的優勢。與其他非典型抗精神病類藥物相比,它具有以下優勢:1、口服給藥,方便患者用藥;2、錐體外系反應較弱,不易引起增重、高血脂症、高催乳素症等不良反應;3、具有提高認知能力、記憶力和改善情緒的潛在優勢。集團開發的鹽酸魯拉西酮片獲批上市,可為國內精神分裂症患者提供更多經濟、高效的用藥選擇。

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