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中國生物製藥(01177.HK):抗抑鬱藥物"氫溴酸伏硫西汀片"獲批
格隆匯 07-27 16:55

格隆匯7月27日丨中國生物製藥(01177.HK)宣佈,集團開發的抗抑鬱藥物"氫溴酸伏硫西汀片"(商品名:晴舒欣)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按化學藥品4類申報,視同通過仿製藥質量和療效一致性評價,國內首家同品種仿製藥獲批。獲批的適應症為:用於治療成人抑鬱症。

伏硫西汀是一款多靶點作用機制的新型抗抑鬱劑,同時具有5-HT轉運體(SERT)抑制作用、5-羥色胺(5-HT1A)受體激動作用以及5-HT3受體拮抗作用。相對於傳統抗抑鬱藥(例如雜環類及三環類抗抑鬱藥),伏硫西汀的療效相當,但副作用較少、安全性和耐受性較好,因此已成為目前歐美國家常用的一線抗抑鬱藥物.。

2017年,世界衞生組織(WHO)指出二十一世紀人類面對的最大疾患是精神疾病,而抑鬱症是其中的重點。2019年,《柳葉刀精神病學》醫學期刊對中國精神衞生調查的患病率數據進行報吿,中國有大約9,500萬名抑鬱症患者。目前國內並無氫溴酸伏硫西汀片仿製製劑上市,集團是國產第一家獲批,打破了原研藥壟斷的局面,可為國內抑鬱症患者提供更多的治療選擇。

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