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石藥集團(01093.HK)治療瀰漫大B細胞淋巴瘤藥獲FDA授快速通道資格
阿思達克 01-27 17:05
石藥集團(01093.HK)公佈,集團開發的首創在研藥物JMT601(CPO107)用於治療成人復發或難治瀰漫大B細胞淋巴瘤獲得美國食品藥品監督管理局(FDA)授予快速通道資格。 授予快速通道資格表明FDA認爲JMT601(CPO107)已表現出具有治療嚴重或危及生命疾病的潛力,並會促進及加快其開發和審評。 一項多中心、首次人體、劑量遞增和劑量擴展的1/2期臨牀試驗目前正在美國進行,以評估JMT601(CPO107)治療晚期非霍奇金氏淋巴瘤患者的安全性、藥代動力學和初步療效。
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