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亞盛醫藥(06855.HK)核心在研產品HQP1351獲得美國FDA審評快速通道資格
格隆匯 05-07 17:07

格隆匯5月7日丨亞盛醫藥-B(06855.HK)發佈公告,美國食品和藥品監督管理局(FDA)已授予公司核心在研產品HQP1351快速通道資格(FTD),用於治療對現有酪氨酸激酶抑制劑(TKIs)治療失敗的特定基因標記的慢性髓性白血病(CML)患者。這是亞盛醫藥獲得的首個快速通道資格。

快速通道資格旨在加速針對嚴重疾病的藥物開發和快速審查,以解決急需滿足的臨牀嚴重疾病醫療需求。CML是一種惡性血液疾病,儘管已上市的BCRABL酪氨酸激酶抑制劑(TKIs)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。HQP1351是亞盛醫藥在研原創新藥,為口服第三代BCR-ABL 抑制劑,用於治療對第一代和第二代TKIs耐藥的CML患者。該產品已於2019年 7月在美國獲准直接進入Ib期臨牀研究,並於近期獲得美國FDA孤兒藥資格認定。

HQP1351也是中國首個第三代BCR-ABL靶向耐藥CML的治療藥物,目前已處於關鍵II期臨牀試驗,預計今年在中國提交新藥上市申請(NDA)。HQP1351的中國臨牀I期試驗進展連續兩年入選美國血液病學會(ASH)年會口頭報告,並獲 2019 ASH“最佳研究”提名。

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