三生製藥(01530.HK)HIF-117膠囊獲國家藥品監管局臨牀試驗批准
格隆匯11月13日丨三生製藥(01530.HK)發佈公告,集團的HIF-117膠囊(“SSS17”)的臨牀試驗申請於2019年11月12日獲得國家藥品監督管理局批准,集團正積極準備開展該產品的臨牀試驗。
根據披露,HIF-117膠囊是一種口服小分子缺氧誘導因子脯氨酸羥化酶(HIF-PH)選擇性抑制劑,該藥物可通過抑制HIF-PH而提高缺氧誘導因子-α(HIF-α)的穩定性和半衰期,從而促進腎臟和其他非腎器官(如肝臟)中促紅素(Erythropoietin,EPO)的分泌,上調骨髓中EPO受體的水平。同時,HIF-PH抑制劑還可通過提高HIF-α而促進腸道中鐵的吸收,動員鐵轉運到骨髓,刺激骨髓中紅細胞的生成,提高血紅蛋白的濃度,從而達到對慢性腎病(Chronic Kidney Disease,CKD)患者貧血的治療作用。
公司的主席兼行政總裁婁競博士評論道:“我們很高興看到SSS17的臨牀試驗申請獲得國家藥品監督管理局正式批准,我們期待於中國加速推進HIF-117膠囊的臨牀試驗進程,預計在未來將與集團的重組人促紅素注射液藥物產生協同效應,為CKD患者提供全週期,全方位的治療選擇。”
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