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亞盛醫藥(06855.HK)核心在研新藥HQP1351於中國提交新藥上市申請
格隆匯 06-18 17:08

格隆匯 6 月 18日丨亞盛醫藥(06855.HK)宣佈,亞盛醫藥的全資子公司廣州順健生物醫藥科技有限公司已向中國國家藥品監督管理局(NMPA)新藥審評中心(CDE)提交HQP1351的新藥上市申請(NDA),用於治療伴有T315I突變的慢性髓性白血病(CML)慢性期和加速期患者。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。

公司已與CDE召開新藥上市申請提交前會議,申請依據HQP1351的兩項關鍵性註冊臨牀研究結果提交NDA。CDE已同意公司提交HQP1351針對兩項適應症的NDA。

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抑制劑對治療CML具有顯着的臨牀效果,但獲得性耐藥一直是CML治療的主要挑戰,其中T315I突變是最常見的耐藥突變類型。因此,CML於臨牀上急需有效的治療藥物。

HQP1351是公司在研的原創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突變體有顯着效果。於2019年7月,HQP1351獲得美國食品及藥物管理局臨牀試驗許可進入Ib期臨牀研究。於2020年5月,HQP1351獲得美國食品及藥物管理局授予的孤兒藥資格和審評快速通道資格。

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