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恆瑞醫藥(600276.SH):蘋果酸法米替尼膠囊用於晚期惡性實體腫瘤治療的臨牀試驗獲批
格隆匯 09-08 17:02

格隆匯 9 月 8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(“國家藥監局”)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。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2020626日受理的蘋果酸法米替尼膠囊符合藥品註冊的有關要求,同意開展用於晚期惡性實體腫瘤治療的臨牀試驗,具體為:SHR-1701 聯合蘋果酸法米替尼治療晚期惡性實體腫瘤患者的開放性、多中心I/II期臨牀研究(SHR-1701-II-203)。

蘋果酸法米替尼膠囊是公司創新研發的小分子多靶點酪氨酸激酶抑制劑。經查詢,蘋果酸法米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,於2005年在美國獲批上市;舒尼替尼由輝瑞公司開發,於2006年在美國獲批上市;培唑帕尼由諾華研發,於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,索拉非尼、舒尼替尼、培唑帕尼的2019年全球銷售額約為21.59億美元。

截至目前,該產品累計已投入研發費用約12304萬元。

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