港股異動丨和黃醫藥拉昇漲近10%,聯合治療晚期腎細胞癌新藥上市申請獲藥監局受理
和黃醫藥(0013.HK)盤中拉昇,一度漲近10%,報26港元,截至目前成交2.2億港元。消息面上,和黃醫藥和信達生物聯合宣佈,呋喹替尼(fruquintinib)和信迪利單抗(sintilimab)聯合療法用於治療既往接受過一種酪氨酸激酶抑制劑治療失敗的局部晚期或轉移性的腎細胞癌患者的新藥上市申請已獲國家藥監局受理。FRUSICA-2研究的數據支持了此項新藥上市申請。FRUSICA-2是一項隨機、開放標籤、陽性對照的註冊研究,旨在評估呋喹替尼和信迪利單抗聯合療法對比阿昔替尼(axitinib)或依維莫司(everolimus)單藥療法用於二線治療晚期腎細胞癌的療效和安全性。該研究已達到盲態獨立中心閱片(BICR)根據RECIST 1.1標準評估的無進展生存期(PFS)的主要終點。該聯合療法亦在包括客觀緩解率(ORR)和緩解持續時間(DoR)在內的次要終點上亦取得改善。安全性特徵可耐受,亦沒有觀察到新的安全訊號。FRUSICA-2研究的數據將提交於近期的學術會議上發表。

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