復星醫藥(600196.SH):ORIN1001片用於特發性肺纖維化治療獲批開展臨牀試驗
格隆匯2月22日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司復星弘創(蘇州)醫藥科技有限公司(“復星弘創”)收到國家藥品監督管理局關於同意其研製的ORIN1001片(“該新藥”)用於特發性肺纖維化(IPF)治療開展臨牀試驗的批准。復星弘創擬於條件具備後於中國境內(不包括港澳台,下同)開展該新藥的I期臨牀試驗。
該新藥為集團自主研發的具有新酶型靶點、新作用機制和新化學結構類型的首創(First-in-Class)小分子藥物,擬用於晚期實體瘤和特發性肺纖維化治療。截至公吿日,該新藥用於晚期實體瘤和特發性肺纖維化治療分別於美國處於I期臨牀試驗中,其用於複發性、難治性、轉移性乳腺癌(包括三陰乳腺癌)已獲美國FDA Fast Track Development Program (即快速通道審評)認證;該新藥用於晚期實體瘤治療於中國境內處於I期臨牀試驗中。
截至公吿日,在全球範圍內尚未有與該新藥同靶點的藥品上市。
截至2022年1月,集團現階段針對該新藥累計研發投入約人民幣18542萬元(未經審計)。
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