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恆瑞醫藥(600276.SH):氟唑帕利膠囊擬納入優先審評程序
格隆匯 12-09 15:35

格隆匯12月9日丨恆瑞醫藥(600276.SH)公佈,公司的氟唑帕利膠囊近日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,公示期7日。

藥品名稱:氟唑帕利膠囊;劑型:膠囊劑;規格:50mg;申報階段:生產;申請人:江蘇恆瑞醫藥股份有限公司;受理號:CXHS1900033;擬優先審評理由:經審核,本申請符合《總局關於鼓勵藥品創新實行優先審評審批的意見》(食藥監藥化管[2017]126號)規定的優先審評審批範圍,同意按優先審評範圍(一)3款具有明顯治療優勢創新藥納入優先審評程序。

2019年10月29日,國家藥品監督管理局藥品審評中心承辦公司此次遞交的藥品註冊申請。氟唑帕利是一種聚腺苷二磷酸核糖聚合酶(poly(ADPribose)polymerase,PARP)抑制劑,可特異性殺傷BRCA突變的腫瘤細胞,用於治療既往經過二線及以上化療的伴有BRCA1/2致病性或疑似致病性突變的複發性卵巢癌。

經查詢,氟唑帕利目前國外有同類產品奧拉帕利(商品名Lynparza)、盧卡帕利(商品名Rubraca)、尼拉帕利(商品名Zejula)和他拉唑帕利(商品名Talzenna)於美國獲批上市銷售,奧拉帕利片於2018年8月在中國獲批上市,商品名為利普卓。國內再鼎醫藥的尼拉帕利在審評審批中,百濟神州的pamiparib(BGB-290)、人福醫藥的HWH-340等產品處於臨牀試驗階段。

經查詢,2018年奧拉帕利(商品名Lynparza)、盧卡帕利(商品名Rubraca)、尼拉帕利(商品名Zejula)和他拉唑帕利(商品名Talzenna)全球銷售額約為6.72億美元,美國銷售額約為3.19億美元。

截至目前,公司在該研發項目上已投入研發費用約1.90億元人民幣。

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