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四環醫藥(00460.HK)馬來酸桂哌齊特注射液(克林澳)獲批新適應症
格隆匯 01-27 23:06

格隆匯1月27日丨四環醫藥(00460.HK)公佈,集團的馬來酸桂哌齊特注射液(克林澳2ml:80mg╱支和安捷利10ml:320mg╱支)用於治療急性缺血性腦卒中的新適應症已於2020年年底成功獲得中國國家藥品監督管理局批准。集團的馬來酸桂哌齊特注射液(克林澳)是目前國內開展藥品上市後臨牀研究以來唯一獲批的腦卒中治療領域的藥品。

馬來酸桂哌齊特注射液(克林澳)是一種弱鈣離子拮抗劑,兼具獨特的內源性腺苷增效作用,能有效改善腦缺血區域的血供。2002年以來,克林澳作為國內第一家上市的馬來酸桂哌齊特注射液,廣泛應用於治療心腦血管及外周血管疾病,已積累了600萬餘人次的臨牀使用經驗,安全性良好。

腦卒中是一種高發病率、高致殘率、高死亡率和高複發率的四高疾病。2019年發表在《柳葉刀》上的中國疾病負擔報吿顯示,1990年至2017年間,腦卒中始終是中國人最主要的死因,每年新發腦卒中患者超過200萬例,位居全球首位。

據IQVIA數據顯示,2019年中國腦卒中處方藥市場規模就已經達到了人民幣1,200億元。集團的馬來酸桂哌齊特注射液(克林澳)治療急性缺血性腦卒中的新適應症被國家藥監局批准,再次證明了其作為腦血管病治療用藥的臨牀價值,未來將為更多未被滿足的腦卒中患者帶來治療獲益,也將對集團的經營業績產生積極影響。

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