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恆瑞醫藥(600276.SH):獲吉非替尼片藥品註冊批件
格隆匯 06-03 16:45

格隆匯6月3日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥監局核准簽發的吉非替尼片(0.25g)《藥品註冊批件》。

吉非替尼是一種選擇性表皮生長因子受體(EGFR)酪氨酸激酶抑制劑。單藥適用於表皮生長因子受體(EGFR)基因具有敏感突變的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的一線治療,以及既往接受過化學治療的局部晚期或轉移性非小細胞肺癌(NSCLC)。

吉非替尼片由AstraZeneca開發,2002年7月在日本獲批上市,2003年5月通過FDA批准上市,2004年12月AstraZeneca的吉非替尼片在中國獲批上市。截至目前,除原研廠家外,國內已有齊魯、正大天晴、湖南科倫獲批上市,另有江蘇天士力等6家申報生產。經查詢evaluatepharma數據庫,2019年原研廠家該產品全球銷售額約為4.23億美元。截至目前,該產品項目已投入研發費用約為3003萬元人民幣。

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