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恒瑞醫藥(600276.SH):阿得貝利單抗注射液獲得藥品註冊證書
格隆匯 03-05 16:03

格隆匯3月5日丨恒瑞醫藥(600276.SH)公佈,近日,公司子公司上海盛迪醫藥有限公司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《藥品註冊證書》。經審查,阿得貝利單抗注射液符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。批准的適應症為"本品與卡鉑和依託泊苷聯合用於廣泛期小細胞肺癌患者的一線治療。"

阿得貝利單抗是公司自主研發的人源化抗 PD-L1 單克隆抗體,能通過特異性結合 PD-L1 分子從而阻斷導致腫瘤免疫耐受的 PD-1/PD-L1 通路,重新激活免疫系統的抗腫瘤活性,從而達到治療腫瘤的目的。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 Atezolizumab 和 Durvalumab 已在中國獲批上市。國內有同類產品康寧傑瑞/思路迪藥業的恩沃利單抗(商品名:恩維達)以及基石藥業的舒格利單抗(商品名:擇捷美)獲國家藥監局批准上市。經查詢,2021 年 Atezolizumab、Avelumab 和 Durvalumab 全球總銷售額合計約為 67 億美元。截至目前,阿得貝利單抗注射液相關項目累計已投入研發費用約 37,305 萬元。

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