恆瑞醫藥(600276.SH)：阿得貝利單抗注射液、SHR-8068注射液獲批開展臨牀試驗
格隆匯5月17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、蘇州盛迪亞生物醫藥有限公司收到藥監局核准簽發關於阿得貝利單抗注射液、SHR-8068注射液的《藥物臨牀試驗批准通知書》，將於近期開展臨牀試驗。經審查，2022年2月17日受理的阿得貝利單抗注射液符合藥品註冊的有關要求，同意本次臨牀試驗申請，具體為：SHR-8068聯合阿得貝利單抗及貝伐珠單抗或含鉑化療治療晚期實體腫瘤的開放、多中心的Ⅰb/Ⅱ期臨牀研究。
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。2022年1月，阿得貝利單抗聯合化療一線治療廣泛期小細胞肺癌的藥品上市許可申請獲藥監局受理。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，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3.21億元。
SHR-8068是公司引進的一種全人源單克隆抗體，可增強抗腫瘤免疫效應。目前全球僅有一款同類產品獲批上市，經查詢該同類產品2021年全球銷售額為20億美元。
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