和譽-B(02256.HK):ABSK011與羅氏聯合用藥II期臨牀試驗獲NMPA批准
格隆匯10月19日丨和譽-B(02256.HK)發佈公吿,2021年10月19日,和譽醫藥宣佈其創新FGFR4抑制劑ABSK011與羅氏製藥(以下簡稱“羅氏”)PD-L1抗體阿替利珠單抗(Atezolizumab)的聯合用藥方案已獲得中國國家藥品監督管理局(NMPA)臨牀II期試驗批件,即將開展針對FGF19陽性晚期或不可切除肝細胞癌患者的研究。
根據披露,ABSK011是一款創新的口服FGFR4小分子抑制劑,由和譽醫藥獨立自主研發。約30%HCC患者中FGF19-FGFR4信號通路異常激活,從而促進腫瘤生長而導致肝癌。臨牀前研究表明ABSK011具有優良的活性、選擇性及其它理化特性。目前 ABSK011的單藥肝細胞癌臨牀試驗在進行中。
研究表明,多種小分子腫瘤精準藥物的聯合療法顯著提高了患者的總體生存期。同樣,腫瘤精準及腫瘤免疫藥物的聯合治療,因為其針對不同的作用機制顯示出更高的療效及更好的安全性。即將開展的ABSK011與阿替利珠單抗聯合用藥的研究將進一步加快其在國內的臨牀開發進程,從而儘早將這一極具潛力的新藥療法帶給患者。
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