恆瑞醫藥(600276.SH)：甲磺酸阿帕替尼片及氟唑帕利膠囊獲批臨牀
格隆匯 8 月 3日丨恆瑞醫藥(600276.SH)公佈，公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》，並將於近期開展臨牀試驗。
藥品1名稱為甲磺酸阿帕替尼片；劑型：片劑；受理號：CXHL2000221、CXHL2000222；藥品2名稱為氟唑帕利膠囊；劑型：膠囊劑；受理號：CXHL2000223。
甲磺酸阿帕替尼是公司創新研發的小分子靶向藥物，2014年獲批上市。經查詢，甲磺酸阿帕替尼目前國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。索拉非尼由拜耳公司開發，最早於2005年在美國獲批上市；舒尼替尼由輝瑞公司開發，最早於2006年在美國獲批上市。培唑帕尼由諾華研發，2009年在美國獲批上市。目前三款多靶點抑制劑均已在國內獲批上市。經查詢IQVIA數據庫，2019年索拉非尼、舒尼替尼和培唑帕尼全球銷售額約為21.59億美元。
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。氟唑帕利膠囊已被國家藥監局藥品審評中心納入優先審評品種，擬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，甲磺酸阿帕替尼累計已投入研發費用約為3.4349億元，氟唑帕利膠囊累計已投入研發費用約為2.5267億元人民幣。
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