和黃醫藥(00013.HK)宣佈沃瑞沙®(ORPATHYS®) 和泰瑞沙® (TAGRISSO®) 的聯合療法用於治療伴有MET擴增的一線EGFR抑制劑治療後疾病進展的肺癌患者的中國新藥上市申請獲受理並獲納入優先審評
格隆匯1月2日丨和黃醫藥(00013.HK)今日宣佈沃瑞沙® (ORPATHYS®,賽沃替尼 / savolitinib)和泰瑞沙® (TAGRISSO®,奧希替尼/ osimertinib)的聯合療法用於治療伴有MET擴增的接受一線表皮生長因子受體(“EGFR”)抑制劑治療後疾病進展的EGFR突變陽性局部晚期或轉移性非小細胞肺癌患者的新藥上市申請已獲中國國家藥品監督管理局(“國家藥監局”)受理並予以優先審評。沃瑞沙®是一種強效、高選擇性的口服MET 酪氨酸激酶抑制劑(“TKI”)。泰瑞沙®是一種不可逆的第三代EGFR TKI 。此次受理也將觸發一項來自阿斯利康的里程碑付款。
和黃醫藥研發負責人及首席醫學官石明博士表示:“這是沃瑞沙®和泰瑞沙®聯合療法的首個監管註冊申請。該聯合療法在解決 MET 驅動的 EGFR 抑制劑耐藥問題方面已展示了明確的證據,並讓延續口服用藥成為可能。透過我們的生物標記物特異性方法,我們希望能夠提高非小細胞肺癌患者的治療連續性和生活質量,以應對這一充滿挑戰的旅程。我們以及合作伙伴阿斯利康正在全球範圍內探索這種聯合療法,開展了一系列包括TATTON、 SAVANNAH、SAFFRON 和ORCHARD 研究在內的後期臨牀試驗。我們希望在不久的將來為患有MET驅動的肺癌患者帶來這種全口服、免化療的治療選擇。”
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