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恆瑞醫藥(600276.SH):“SHR-1316注射液”獲批臨牀試驗
格隆匯 08-05 17:54

格隆匯 8 月 5日丨恆瑞醫藥(600276.SH)公佈,公司及子公司蘇州盛迪亞生物醫藥有限公司、上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

藥品名稱:SHR-1316注射液

劑型:注射劑

申請事項:臨牀試驗

受理號:CXSL2000099

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,2020年5月7日受理的SHR-1316注射液符合藥品註冊的有關要求,同意按照提交的方案開展侷限期小細胞肺癌的臨牀試驗。

SHR-1316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。其中Durvalumab(商品名Imfinzi?)和Atezolizumab(商品名Tecentriq?)均已在國內獲批上市。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約為15,637萬元

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