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恆瑞醫藥(600276.SH)獲得藥物臨牀試驗批准通知書
格隆匯 07-13 16:25

格隆匯7月13日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司、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注射用甲苯磺酸瑞馬唑侖及SHR-1316注射液的《藥物臨牀試驗批准通知書》。

注射用甲苯磺酸瑞馬唑侖是一種短效的GABAA受體激動劑,已獲批的適應症為常規胃鏡檢查鎮靜和結腸鏡檢查鎮靜。經查詢,國內外尚無同適應症同類產品上市銷售。PaionAG公司開發的瑞馬唑侖的苯磺酸鹽,2018年12月在日本授權萌蒂製藥提交上市申請,2019年4月在美國提交新藥申請,2020年7月美國FDA批准苯磺酸瑞馬唑侖用於程序鎮靜的誘導與維持。宜昌人福(PaionAG公司授權)於2018年11月15日向國家藥品監督管理局提交苯磺酸瑞馬唑侖上市申請,目前狀態為“在審評審批中”。截至目前,該產品累計已投入研發費用約為8018萬元人民幣。

SHR-1316作為PD-L1單抗藥物,可以解除PD-L1介導的免疫抑制效應,增強殺傷性T細胞的功能,發揮調動機體免疫系統清除體內腫瘤細胞的作用。SHR-1316為公司自主研發產品。經查詢,SHR-1316目前國外有同類產品Atezolizumab(商品名Tecentriq®)、Avelumab(商品名Bavencio®)和Durvalumab(商品名Imfinzi®)於美國獲批上市銷售。2019年12月,Durvalumab(商品名Imfinzi®)在國內獲批上市。國內有CS1001等多個同類產品處於臨牀試驗階段。經查詢,2019年Atezolizumab、Durvalumab和Avelumab全球總銷售額約為35.08億美元。截至目前,該產品累計已投入研發費用為1.56億元。

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