紅日藥業(300026.SZ):KB項目獲得美國FDA快速通道資格
格隆匯1月4日丨紅日藥業(300026.SZ)公佈,公司在研產品注射用甲磺酸苦柯胺B(簡稱“KB”)獲得美國食品藥品監督管理局(簡稱“FDA”)授予快速通道資格(Fast Track Designation,以下簡稱“FTD”),用於治療膿毒症。
KB是目前全球唯一的一種雙靶標細菌病原體相關分子拮抗劑,是以LPS和CpG DNA為雙靶標研發的治療膿毒症藥物。其作用機理是KB能夠高親和力結合LPS和CpG DNA,通過藥物與LPS和CpG DNA的高親合力結合作用,阻斷LPS和CpG DNA與相應受體的結合,在有效控制感染的前提下,抑制LPS和CpG DNA誘導免疫細胞釋放炎症介質TNF-α和IL-6,從而抑制機體因細菌感染而導致的系統性炎症反應,從而達到治療膿毒症的目的。
該產品於2014年6月獲得國家藥品監督管理局核准簽發的《藥物臨牀試驗批件》(批件號:2014L01029),於2018年2月獲得II/III期臨牀批件(批件號:2018L02111),目前在國內正在開展IIb期臨牀研究;於2021年10月,獲得FDA下發的關於同意KB(CHS-201)治療膿毒症開展的II期臨牀的通知。
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