恆瑞醫藥(600276.SH)：甲磺酸阿帕替尼片、SHR-1701注射液獲批臨牀
格隆匯1月5日丨恆瑞醫藥(600276.SH)公佈，近日，公司及子公司蘇州盛迪亞生物醫藥有限公司收到國家藥監局核准簽發關於甲磺酸阿帕替尼片、SHR-1701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。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2021年10月15日受理的甲磺酸阿帕替尼片、SHR-1701注射液符合藥品註冊的有關要求。同意開展臨牀試驗，具體為一項“SHR-1701聯合甲磺酸阿帕替尼加或不加化療治療晚期惡性實體腫瘤患者的開放性、多中心II期臨牀研究”(研究編號：SHR-1701-Ⅱ-212)。
甲磺酸阿帕替尼片(商品名：艾坦)於2014年11月獲批用於既往至少接受過2種系統化療後進展或復發的晚期胃腺癌或胃-食管結合部腺癌患者的治療；於2020年12月獲批用於既往接受過至少一線系統性治療後失敗或不可耐受的晚期肝細胞癌患者的治療。
甲磺酸阿帕替尼片國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。索拉非尼由拜耳公司開發，2005年在美國獲批上市；舒尼替尼由輝瑞公司開發，2006年在美國獲批上市；培唑帕尼由諾華研發，2009年在美國獲批上市。索拉非尼、舒尼替尼、培唑帕尼均已在國內上市。經查詢Evaluate Pharma數據庫，2020年索拉非尼、舒尼替尼和培唑帕尼全球銷售額合計約為21.83億美元。截至目前，甲磺酸阿帕替尼相關項目累計已投入研發費用約4.05億元。
SHR-1701可以促進效應性T細胞的活化，同時還可有效改善腫瘤微環境中的免疫調節作用，最終有效促進免疫系統對於腫瘤細胞的殺傷。SHR-1701注射液已在中國開展多項實體瘤臨牀試驗，並在澳洲開展I期臨牀試驗。經查詢，Merck KGaA公司、普米斯生物技術、蘇州創勝集團、博際生物醫藥、齊魯製藥、友芝友的同類產品在國內外處於臨牀試驗階段，適應症以晚期惡性腫瘤為主。國內外尚無同類產品獲批上市，亦無相關銷售數據。截至目前，SHR-1701相關項目累計已投入研發費用約2.40億元。
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