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恆瑞醫藥(600276.SH):氟唑帕利膠囊及SHR3680片獲臨試通知
格隆匯 10-20 15:43

格隆匯10月20日丨恆瑞醫藥(600276.SH)宣佈,公司近日收到國家藥監局核准簽發的關於氟唑帕利膠囊及SHR3680片的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

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。

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。國內再鼎醫藥的甲苯磺酸尼拉帕利膠囊(商品名則樂)於2019年12月在中國獲批上市,用於鉑敏感的複發性上皮性卵巢癌、輸卵管癌或原發性腹膜癌成人患者在含鉑化療達到完全緩解或部分緩解後的維持治療。

經查詢,2019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13.57億美元,美國銷售額約為6.74億美元。截至目前,該產品累計已投入研發費用約為2.7455億元。

SHR3680是一種AR受體拮抗劑,擬用於去勢治療失敗或者採用傳統的激素治療方法失敗的前列腺癌的治療。目前全球已有比卡魯胺、恩雜魯胺等6個AR拮抗劑上市,在中國有比卡魯胺、恩雜魯胺和阿帕魯胺獲批上市。

經查詢Evaluate Pharma數據庫,比卡魯胺2019年度全球銷售額約為2.44億美元,恩雜魯胺2019年度全球銷售額約為36.8億美元,阿帕魯胺2019年度全球銷售額約為3.32億美元。截至目前,該產品累計已投入研發費用約1.8005億元人民幣。

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