亞盛醫藥-B(06855.HK)奧瑞巴替尼(HQP1351)納入優先審評
格隆匯 10 月 21日丨亞盛醫藥-B(06855.HK)宣佈,公司全資子公司廣州順健生物醫藥科技有限公司的1類新藥奧瑞巴替尼片(HQP1351的擬定中文通用名)獲中華人民共和國國家藥品監督管理局(NMPA)新藥審評中心(CDE)公示,符合臨牀急需新藥的審評審批工作程序,已被納入優先審評。此次在國內遞交的上市申請是依據奧瑞巴替尼的兩項關鍵性II期臨牀研究結果,用於治療酪氨酸激酶抑制劑(TKI)耐藥後並伴有T315I突變的慢性髓性白血病(CML)慢性期或加速期的成年患者。
根據NMPA2020年7月1日施行的《藥品註冊管理辦法》(國家市場監督管理總局令第27號)和7月7日施行的《藥品上市許可優先審評審批工作程序(試行)》(2020年第82號),通過設立優先審評審批制度以加快具有重大臨牀價值和臨牀急需新藥的開發。審批部門將優先審核和評估獲得優先審評資格的藥品,以縮短審評審批時間,有利於加快市場準入。奧瑞巴替尼被納入優先審評品種,意味着其審批速度有望加快,若申請獲批,HQP1351有望成為在中國上市的首個第三代BCR—ABL抑制劑。
CML是一種與白細胞有關的惡性腫瘤。儘管第一代與第二代BCR—ABL抑制劑對CML的治療具有顯着的臨牀效益,但獲得性耐藥一直是CML治療的主要挑戰。其中T315I突變是常見的耐藥突變類型之一,因此臨牀上急需有效的新一代治療藥物。
奧瑞巴替尼是亞盛醫藥在研原創1類新藥,為口服第三代BCR—ABL抑制劑,對BCR—ABL以及包括T315I突變在內的多種BCR—ABL突變體有突出效果。2019年7月,該品種獲美國FDA臨牀試驗許可,直接進入Ib期臨牀研究。2020年5月,奧瑞巴替尼接連獲得美國FDA授予的孤兒藥資格和審評快速通道資格。
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