復星醫藥(600196.SH):子公司NS012獲美國FDA藥品臨牀試驗批准
格隆匯9月21日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司Novelstar Pharmaceuticals Inc.收到美國FDA(即美國食品藥品監督管理局)關於同意NS012用於治療慢性心力衰竭進行臨牀試驗的函(IND編號:153349)。
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)自主研發的改良型新藥,擬用於治療慢性心力衰竭。
截至本公吿日,與該新藥同類型藥品已在全球範圍內上市。根據IQVIAMIDASTM最新數據,2020年度,與該新藥同類型藥品於全球的銷售額約為32億美元。截至2021年8月,本集團現階段針對該新藥累計研發投入摺合人民幣約640萬元(未經審計)。
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