恆瑞醫藥(600276.SH):甲磺酸阿帕替尼治療胃癌或胃食管交界處癌獲批臨牀
格隆匯7月6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關於甲磺酸阿帕替尼片的《藥物臨牀試驗批准通知書》。截至目前,甲磺酸阿帕替尼相關項目累計已投入研發費用約為4.01億元。
根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年4月25日受理的甲磺酸阿帕替尼片符合藥品註冊的有關要求,同意開展用於胃癌或胃食管交界處癌治療的臨牀試驗,具體為:卡瑞利珠單抗(SHR-1210)聯合卡培他濱和奧沙利鉑序貫卡瑞利珠單抗聯合甲磺酸阿帕替尼治療既往未接受過系統治療的晚期或轉移性胃癌(GC)或胃食管交界處癌(GEJ)的隨機、開放性、多中心III期臨牀研究(方案編號:SHR-1210-III-311)。
甲磺酸阿帕替尼片已於2014年11月獲得國家藥監局批准單藥用於既往至少接受過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;於2020年12月獲得國家藥監局批准用於既往接受過至少一線系統性治療後失敗或不可耐受的晚期肝細胞癌患者。
經查詢,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。索拉非尼、舒尼替尼、培唑帕尼均已在國內上市。
經查詢EvaluatePharma數據庫,2020年索拉非尼、舒尼替尼和培唑帕尼全球銷售額合計約為21.83億美元。
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