恒瑞醫藥(01276.HK)：注射用SHR-A2102、阿得貝利單抗注射液獲批開展臨牀試驗
格隆匯8月13日丨恒瑞醫藥(01276.HK)公佈，近日，公司子公司蘇州盛迪亞生物醫藥有限公司、上海恒瑞醫藥有限公司、上海盛迪醫藥有限公司收到國家藥監局核准簽發關於注射用SHR-A2102、阿得貝利單抗注射液的《藥物臨牀試驗批准通知書》，將於近期開展臨牀試驗。
注射用 SHR-A2102 為公司自主研發且具有知識產權的靶向 Nectin-4 的抗體藥物偶聯物(ADC)，其有效載荷是拓撲異構酶Ⅰ抑制劑(TOP1i)。多種研究表明 Nectin-4 在腫瘤中的高表達與腫瘤的發展和不良預後密切相關。目前全球共有 1 款同類產品獲批上市，為 Enfortumab vedotin(商品名：Padcev)，經查詢EvaluatePharma 數據庫，2024 年該產品全球銷售額約為 19.49 億美元。截至目前，注射用 SHR-A2102 相關項目累計研發投入約 20,547 萬元。
阿得貝利單抗注射液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。公司阿得貝利單抗注射液(商品名：艾瑞利)已於 2023 年 3 月獲批上市，獲批的適應症為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。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。國內有康寧傑瑞/思路迪藥業的恩沃利單抗、基石藥業的舒格利單抗和正大天晴藥業的貝莫蘇拜單抗等同類產品獲批上市。經查詢，2024 年 Atezolizumab、Avelumab 和 Durvalumab 全球銷售額合計約為 96.48億美元。截至目前，阿得貝利單抗注射液相關項目累計研發投入約 90,130 萬元。
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