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恆瑞醫藥(600276.SH):子公司收到SHR-1701注射液、貝伐珠單抗注射液的藥物臨牀試驗批准通知書
格隆匯 10-11 17:28

格隆匯10月11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核准簽發關於SHR-1701注射液、貝伐珠單抗注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

2021年6月,公司的貝伐珠單抗注射液(商品名:艾瑞妥)獲批用於轉移性結直腸癌和晚期、轉移性或複發性非小細胞肺癌;2021年9月,獲批用於複發性膠質母細胞瘤。

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,MerckKGaA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為2.22億元。

貝伐珠單抗是一種人源化抗VEGF單克隆抗體,由中外製藥和羅氏的子公司基因泰克合作開發,最早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),目前已在中國和全球多個國家上市銷售。除安維汀及艾瑞妥外,國內目前有3個貝伐珠單抗注射液獲批上市,分別為齊魯製藥的安可達、信達生物的達攸同和山東博安生物的博優諾。同時,國內多家企業的同類產品已向國家藥品監督管理局遞交上市申請,目前狀態為“在審評審批中”,包括綠葉製藥、貝達藥業、百奧泰等。

經查詢Evaluate Pharma數據庫,安維汀2020年全球銷售額約53.24億美元。截至目前,貝伐珠單抗相關項目累計已投入研發費用約為2.631億元。

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