恆瑞醫藥(600276.SH)獲氟唑帕利膠囊及甲磺酸阿帕替尼片臨牀試驗通知書
格隆匯3月2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《臨牀試驗通知書》，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。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。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。
甲磺酸阿帕替尼是公司創新研發的小分子靶向藥物，2014年獲批上市用於治療既往至少接受過2種系統化療後進展或復發的晚期胃腺癌或胃-食管結合部腺癌患者。經查詢，甲磺酸阿帕替尼目前國內外有Solafeinib、Sunitinib等同類產品已獲批上市。Solafeinib由拜耳公司開發，最早於2005年在美國獲批上市；Sunitinib由輝瑞公司開發，最早於2006年在美國獲批上市。2018年甲磺酸阿帕替尼銷售額約為17億元人民幣。
截至目前，公司在氟唑帕利項目上已投入研發費用約20,230萬元人民幣，甲磺酸阿帕替尼項目已投入研發費用約為33,234萬元人民幣。
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