復星醫藥(02196.HK)子公司治療肺纖維化新藥獲美國FDA同意進行臨床試驗
復星醫藥(02196.HK)公布,近日,集團控股子公司Orinove收到國食品藥品監督管理局(FDA)關於同意ORIN1001片用於特發性肺纖維化治療進行臨床試驗的函。Orinove擬於近期條件具備後於美國開展該新藥針對該適應症的Ib期臨床試驗。
該新藥為集團自主研發的具有新(酉每)型靶點、新作用機制和新化學結構類型的首創小分子藥物,擬用於晚期實體瘤、特發性肺纖維化治療。目前,該新藥用於晚期實體瘤治療於美國處於一期臨床試驗中,其用於復發性、難治性、轉移性乳腺癌(包括三陰乳腺癌)已獲美國FDA快速通道審評認證;該新藥用於晚期實體瘤治療已獲國家藥品監督管理局臨床試驗批准。
截至今年9月,集團現階段針對該新藥累計研發投入約為1.11億元人民幣。
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