恆瑞醫藥(600276.SH)：SHR-1701注射液、貝伐珠單抗注射液獲批臨牀試驗
格隆匯9月6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、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。
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，目前Merck KGaA 公司，普米斯生物技術、蘇州創勝集團、博際生物醫藥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22217萬元。
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)，目前已在中國和全球多個國家上市銷售。公司貝伐珠單抗注射液(商品名：艾瑞妥)已於2021年6月獲批上市。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2019 年12 月獲批的安可達(齊魯製藥)、2020年6月獲批的達攸同(信達生物)和2021年4月獲批的博優諾(山東博安生物)。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、東曜藥業、復宏漢霖、正大天晴等。
經查詢EvaluatePharma 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26310萬元。
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