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恆瑞醫藥(600276.SH):蘋果酸法米替尼膠囊及SHR-1701注射液獲批臨牀試驗
格隆匯 01-07 17:16

格隆匯1月7日丨恆瑞醫藥(600276.SH)公佈,公司及子公司蘇州盛迪亞生物醫藥有限公司近日收到國家藥監局核准簽發的關於蘋果酸法米替尼膠囊及SHR-1701注射液的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

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為1.28億元。

SHR-1701可以促進效應性T細胞的活化,同時還可有效改善腫瘤微環境中的免疫調節作用,最終有效促進免疫系統對於腫瘤細胞的殺傷。經查詢,目前Merck KGaA公司的同類產品在國內外處於臨牀試驗階段,適應症以晚期惡性腫瘤為主。國內外尚無同類靶點產品獲批上市,亦無相關銷售數據。截至目前,該產品累計已投入研發費用約為1.22億元。

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