貝達藥業(300558.SZ)收到CDE簽發的關於鹽酸恩沙替尼原料藥和製劑的補充資料通知書
格隆匯12月29日丨貝達藥業(300558.SZ)公佈,近日,公司收到國家藥品監督管理局藥品審評中心(“CDE”)籤發的關於鹽酸恩沙替尼原料藥和製劑的《補充資料通知書》,公司需向CDE遞交藥學研究補充資料。
2018年12月26日,鹽酸恩沙替尼的藥品註冊申請獲得國家藥品監督管理局受理(詳見公司於12月28日披露的《關於鹽酸恩沙替尼藥品註冊申請獲得受理的公告》)。2019年2月25日,鹽酸恩沙替尼作為具有明顯治療優勢的創新藥,其上市申請被正式納入優先審評程序。截止目前,鹽酸恩沙替尼臨牀核查工作已經完成,此次公司將按照CDE要求補充藥學研究資料。
作為一種新型強效、高選擇性的新一代ALK 抑制劑,鹽酸恩沙替尼治療克唑替尼耐藥的ALK陽性非小細胞肺癌患者具有良好的療效和安全性,經獨立評審委員會(IRC)對截止2019年5月底的II期臨牀研究數據進行評估,在療效性方面,鹽酸恩沙替尼整體ORR為52.6%,中位PFS為11.2個月,疾病控制率為87.8%,顱內ORR為71.4%,顱內病灶控制率達95.2%。國際知名醫學學術期刊《柳葉刀·呼吸醫學》(The Lancet Respiratory Medicine)全文發表鹽酸恩沙替尼的臨牀研究成果,新藥療效確切、安全,且一天只需服藥一次,獲得專家關注和認可。
針對通知書要求補充的藥學研究資料,公司已第一時間安排和展開相關工作,團隊分工合作,羣策羣力,全力推進,力爭儘快完成補充材料的遞交,並積極做好新藥上市的相關準備工作,儘早讓鹽酸恩沙替尼造福患者。
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