恆瑞醫藥(600276.SH)子公司獲2個藥物臨牀試驗批准通知書
格隆匯1月14日丨恆瑞醫藥(600276.SH)公佈,公司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貝伐珠單抗注射液及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。
貝伐珠單抗是一種人源化抗-VEGF單克隆抗體,由羅氏的子公司基因泰克和中外製藥合作開發,最早於2004年由美國食品藥品監督管理局批准上市,商品名為Avastin(安維汀),適應症為轉移性結直腸癌,隨後陸續批准用於治療非小細胞肺癌、惡性膠質瘤、轉移性腎細胞癌、轉移性宮頸癌、腹膜癌、肝細胞癌等多種適應症,目前已在中國和全球多個國家上市銷售。截至目前,該產品累計已投入研發費用約為1.79億元。
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MerckKGaA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12,634萬元。
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