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恆瑞醫藥(600276.SH):SHR-1701注射液獲批臨牀試驗
格隆匯 11-26 17:17

格隆匯11月26日丨恆瑞醫藥(600276.SH)公佈,近日,公司子公司蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局(“國家藥監局”)核准籤發關於SHR-1701注射液《藥物臨牀試驗批准通知書》,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,2021917日受理的SHR-1701注射液符合藥品註冊的有關要求,同意此次臨牀試驗申請,具體為:SHR-1701注射液聯合甲磺酸侖伐替尼膠囊對比蘋果酸舒尼替尼膠囊一線治療晚期腎細胞癌的多中心、隨機、對照、開放的III期臨牀研究(SHR-1701-III-317)。

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。SHR-1701注射液已在中國開展多項實體瘤臨牀試驗,並在澳洲開展 I 期臨牀試驗。經查詢,Merck KGaA公司、普米斯生物技術、蘇州創勝集團、博際生物醫藥、齊魯製藥、友芝友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。國內外尚無同類產品獲批上市,亦無相關銷售數據。截至目前,SHR-1701相關項目累計已投入研發費用約23791萬元。

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