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恆瑞醫藥(600276.SH):PD-L1單抗藥物SHR-1316獲臨牀試驗通知
格隆匯 12-30 19:47

格隆匯12月30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品監督管理局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。

2019年10月15日,公司向國家藥監局提交的本品臨牀試驗申請獲受理,具體為SHR-1316聯合卡鉑和依託泊苷對比安慰劑聯合卡鉑和依託泊苷一線治療廣泛期小細胞肺癌的隨機、雙盲、安慰劑對照、多中心的III期臨牀研究。

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,2018年Atezolizumab、Durvalumab和Avelumab全球總銷售額約為14.56億美元。截至目前,該產品項目已投入研發費用約為1.08億元人民幣。

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