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亞盛醫藥-B(06855.HK):MDM2-p53抑制劑APG-115獲FDA快速通道資格,治療復發╱難治性不可切除╱轉移性黑色素瘤
格隆匯 09-23 07:33

格隆匯9月23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alrizomadlin(APG-115)獲得美國食品和藥品監督管理局(FDA)授予的快速通道資格(FTD),用於經腫瘤免疫治療後的復發╱難治性不可切除╱轉移性黑色素瘤患者。此前,APG-115已獲得FDA授予的五項孤兒藥資格認證(ODD),其中一項適應症為IIB-IV期黑色素瘤。

FTD旨在加速針對嚴重疾病的藥物開發和快速審查,以解決關鍵領域嚴重未獲滿足的臨牀醫療需求。APG-115此次獲得FTD,意味着其有機會以各種形式的加快審評進程,包括在研發階段可以與FDA進行更頻繁的會晤與溝通;在滿足相關標準的情況下,實行滾動式審評機制,即可分階段遞交NDA申報資料,而不需要待所有資料全部完成後再提交審評;快速通道資格的授予也有望令APG-115進一步獲得優先審評和加速批准資格。

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