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長江生命科技(00775.HK):Halneuron®(注射用河豚毒素(Tetrodotoxin))獲美國FDA授予快速通道資格認定
格隆匯 08-22 08:22

格隆匯8月22日丨長江生命科技(00775.HK)發佈公吿,美國食品及藥物管理局(“FDA”)已向公司全資擁有的後期藥物開發公司WEX Pharmaceuticals Inc.就針對治療因化療引致的神經痛症(“CINP”)用的Halneuron®(注射用河豚毒素(Tetrodotoxin)),授予快速通道資格認定(Fast Track designation)。

據悉,FDA的快速通道計劃旨在加快開發與審查處理嚴重病情的治療方法及未獲解決的醫療需求,有助患者更快獲得新藥。取得快速通道資格認定的公司可受惠於在臨牀開發階段中與FDA進行更頻繁的溝通,並且在達致必要條件時,或可符合獲加快批准或優先審評的資格。

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