恆瑞醫藥(600276.SH)：阿得貝利單抗注射液上市許可申請獲受理
格隆匯1月24日丨恆瑞醫藥(600276.SH)公佈，近日，公司子公司上海盛迪醫藥有限公司有限公司收到國家藥品監督管理局(以下簡稱“藥監局”)下發的《受理通知書》，公司提交的阿得貝利單抗注射液的藥品上市許可申請獲藥監局受理。擬定適應症(或功能主治)：本品聯合化療一線治療廣泛期小細胞肺癌。
2021年10月，SHR-1316注射液(阿得貝利單抗注射液)聯合化療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(方案編號：SHR-1316-Ⅲ-301)主要研究終點結果達到方案預設的優效標準。SHR-1316-Ⅲ-301研究由吉林省腫瘤醫院程穎教授和中國醫學科學院腫瘤醫院王潔教授共同擔任主要研究者，全國49家中心共同參與，共入組462例受試者，按照1:1隨機入組，分別接受SHR-1316注射液或安慰劑聯合依託泊苷和卡鉑，每3周給藥1次，完成4-6個週期聯合治療後，進入SHR-1316注射液或安慰劑維持治療，直至疾病進展、毒性不可耐受或其他需要終止治療的情況。研究結果表明，SHR-1316聯合化療對比安慰劑聯合化療可以顯著延長患者生存(OS)。
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。現有多項阿得貝利單抗注射液臨牀研究正在進行，以評估其在各類實體腫瘤的抗腫瘤作用。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)獲藥監局批准上市。經查詢，2020年Atezolizumab、Avelumab和Durvalumab全球總銷售額合計約為51.41億美元。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27378萬元。
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