復星醫藥(600196.SH):NS002片獲批美國FDA藥品臨牀試驗
格隆匯2月10日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司Novelstar Pharmaceuticals Inc.(以下簡稱“Novelstar”)收到美國FDA(即美國食品藥品監督管理局,下同)關於同意NS002片(以下簡稱“該新藥”)用於炎性關節病治療進行臨牀試驗的函(IND編號:151851)。Novelstar擬於近期條件具備後於美國開展該新藥針對上述適應症的BA(相對生物利用度)臨牀試驗。
該新藥為集團(即公司及控股子公司/單位,下同)自主研發的用於治療炎性關節病的改良型新藥。截至2020年12月,集團現階段針對該新藥累計研發投入摺合人民幣約602萬元(未經審計)。
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