恆瑞醫藥(600276.SH)：國家藥監局已受理氟唑帕利膠囊的藥品註冊申請
格隆匯10月30日丨恆瑞醫藥(600276.SH)公佈，近日，公司研發的氟唑帕利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的單臂、多中心臨牀研究(研究編號：HR-FZPL-Ib-OC)，截至2019年7月的研究數據表明，氟唑帕利在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患者中療效達到並超過預設，且毒性可控、可耐受，可為中國BRCA突變復發卵巢癌患者提供新的治療選擇。基於該臨牀研究已有數據，國家藥監局受理了氟唑帕利膠囊的藥品註冊申請。
氟唑帕利是一種聚腺苷二磷酸核糖聚合酶(poly(ADP-ribose)polymerase , PARP)抑制劑，可特異性殺傷BRCA突變的腫瘤細胞。恆瑞醫藥於2018年2月啟動一項氟唑帕利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的單臂、多中心臨牀研究(研究編號：HR-FZPL-Ib-OC)，研究共計入組113例受試者接受藥物治療，截至2019年7月的研究數據表明，氟唑帕利在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患者中療效達到並超過預設，且毒性可控、可耐受，可為中國BRCA突變復發卵巢癌患者提供新的治療選擇。
國家藥監局受理了氟唑帕利膠囊的藥品註冊申請，受理號為CXHS1900033國。
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)、瑛派藥業的IMP4297及人福醫藥的HWH-340等產品處於臨牀試驗階段。
經查詢IMS數據庫，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6.72億美元，美國銷售額約3.19億美元。
截至目前，公司在該產品研發上已投入研發費用約1.8235億元人民幣。
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