亞盛醫藥-B(06855.HK):MDM2-p53抑制劑APG-115獲得美國FDA兒童罕見病資格認證,用於治療神經母細胞瘤
格隆匯3月22日丨亞盛醫藥-B(06855.HK)發佈公吿,公司在研原創新藥MDM2-p53抑制劑APG-115 (alrizomadlin)獲得美國食品和藥品監督管理局(FDA)授予的兒童罕見病資格認證(Rare Pediatric Disease,RPD),用於治療神經母細胞瘤。截止該公吿日期,APG-115已獲得FDA授予的六項孤兒藥資格認證(ODD)、兩項RPD。
2012年開始實施的FDA安全和創新法案(FDASIA)確立了RPD計劃以及與其相關的優先審評券(Priority Review Voucher,PRV)制度,旨在鼓勵針對治療兒童罕見病的創新療法的開發。FDASIA對兒童罕見病的定義包括:指主要影響從出生到18歲年齡段間的個體,包括新生兒、嬰兒、兒童及青少年,同時是罕見病(在美國受影響人羣不超過20萬)。有資格獲得PRV,是通過RPD認定最為突出的優勢。申辦方可以通過兑換PRV以加速其他產品的後續新藥申請或生物製品許可申請的審評;也可以將PRV轉讓給其他申辦方使用。
APG-115是亞盛醫藥自主研發的一種口服、高選擇性的MDM2-p53抑制劑,對 MDM2具有高度結合親和力,通過阻斷MDM2-p53相互作用從而恢復p53腫瘤抑制活性。目前,APG-115已經在體外和體內神經母細胞瘤模型中證明了單藥治療的抗腫瘤活性,該作用機制的明確為該藥物治療神經母細胞瘤的臨牀探索提供了良好的基礎。
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