億帆醫藥(002019.SZ): 子公司治療aGvHD藥物獲美“孤兒藥”認定
格隆匯10月23日丨億帆醫藥(002019.SZ)宣佈,公司控股子公司上海健能隆於2019年10月22日收到美國FDA孤兒藥開發辦公室的正式書面回函,上海健能隆於2019年7月25日提交的最新修訂的《重組人白介素22-Fc融合蛋白(下稱“F-652項目”)作為治療“急性移植物抗宿主病”的孤兒藥申請》獲得美國FDA正式認定並獲批准,美國FDA同時在其官方網站對上海健能隆的F-652項目的孤兒藥申請認定情況進行了公示。
此次上海健能隆獲得美國FDA批准的孤兒藥資格認定的是F-652項目用於治療治療急性移植物抗宿主病(下稱“aGvHD”)的適應症。aGvHD是移植後早期死亡的重要併發症之一,發生於供體T細胞對抗受體抗原激活,從而攻擊重要的受體器官,特別是皮膚、肝臟和胃腸道,少數情況下也可累及其他臟器。
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