亞盛醫藥(06855.HK):HQP1351獲得美國FDA孤兒藥資格認定
格隆匯5月4日丨亞盛醫藥(06855.HK)宣佈,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孤兒藥資格認定,用於治療慢性髓性白血病(CML)。這是亞盛醫藥獲得的首個孤兒藥資格認定。
"孤兒藥"又稱為罕見病藥,指用於預防、治療、診斷罕見病的藥品。CML是一種罕見的惡性血液疾病,儘管已上市的BCR-ABL酪氨酸激酶抑制劑(TKIs)具有顯著的臨牀效果,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。
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2019ASH"最佳研究"提名。
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