歌禮制藥-B(01672.HK)臨牀試驗方案獲中國藥監局批準
歌禮制藥-B(01672.HK)公佈,全資附屬甘萊的ASC42治療原發性膽汁性膽管炎的II、III期臨牀試驗方案已獲中國藥監局批準。甘萊預計將於明年下半年完成100例患者的II期臨牀試驗,隨後啓動140至
210例患者的III期臨牀試驗,完成中國II期臨牀試驗後,將在美國和歐盟啓動III期臨牀試驗。
公司表示,PBC是ASC42治療慢性肝膽疾病的又一個新適應症,另外兩個已被中國NMPA和美國食品藥品監督管理局批準的慢性肝膽疾病適應症爲慢性乙型肝炎和非酒精性脂肪性肝炎。
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