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海南海藥(000566.SZ):收到氟非尼酮膠囊I期臨牀試驗總結報告 Ⅱ期臨牀試驗工作將於近期啟動
格隆匯 09-03 17:55

格隆匯 9 月 3日丨海南海藥(000566.SZ)公佈,公司控股子公司海口市制藥廠有限公司與中南大學聯合申請的氟非尼酮膠囊於近日收到I期臨牀試驗總結報告。氟非尼酮是一種具有抗纖維化作用的吡啶酮類化合物,由海口市制藥廠有限公司和中南大學聯合開發,屬於化藥創新藥1.1類新藥。目前氟非尼酮膠囊已完成I期臨牀試驗並獲得臨牀試驗總結報告。主要情況如下:

一、基本信息

藥物名稱:氟非尼酮膠囊

註冊分類:化學藥品第1類

劑型:膠囊劑

適應症:肝纖維化

臨牀批件號:2016L09979

研究內容:單次給藥、多次給藥安全性、耐受性及藥代動力學

研究機構:首都醫科大學附屬北京天壇醫院、首都醫科大學附屬北京佑安醫院

二、I期臨牀研究情況

試驗結果顯示良好的安全性和耐受性,整個試驗過程,無嚴重不良事件發生。氟非尼酮膠囊I期臨牀試驗達到預期試驗目的,併為Ⅱ期臨牀試驗的開展提供充分的依據,Ⅱ期臨牀試驗工作將於近期啟動。

氟非尼酮膠囊I期臨牀試驗的完成,對公司的財務狀況、經營業績不構成影響。作為創新藥其後續臨牀試驗是否成功、未來是否獲得國家藥品監督管理局上市批准,具有一定的不確定性。公司將對該項目的後續進展情況及時履行信息披露義務,敬請廣大投資者謹慎決策,控制投資風險。

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