恆瑞醫藥(600276.SH):PD-L1單抗藥物SHR-1316獲批臨牀試驗
格隆匯12月6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,藥品名稱為SHR-1316注射液。
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,國內尚無同類產品獲批上市銷售。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10838萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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