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中國生物製藥(01177.HK):"TDI01"混懸液獲批塵肺病臨牀試驗
格隆匯 03-08 16:38

格隆匯3月8日丨中國生物製藥(01177.HK)宣佈,集團自主研發的一類創新藥"TDI01"混懸液獲得中國國家藥品監督管理局批准開展用於塵肺病的臨牀試驗。TDI01是全新靶點、高選擇性的Rho/Rho相關捲曲螺旋形成蛋白激酶2(ROCK2)抑制劑,國家十三五重大新藥品種,其已在美國完成I期臨牀試驗,安全性良好,目前正在國內開展橋接試驗。TDI01此前已在國內獲得批准開展特發性肺纖維化的臨牀試驗,塵肺病為其第二個獲批開展臨牀的適應症,集團將繼續探索其在更多的纖維化及其相關領域的應用。

塵肺病是勞動者在職業活動中長期吸入生產性粉塵(灰塵),並在肺內瀦留而引起的以肺組織瀰漫性纖維化(瘢痕)為主的全身性疾病。它會導致患者出現咳嗽、胸悶、氣短、呼吸困難等症狀,並且會對肺功能造成嚴重影響,對患者身體危害極大。目前國內外尚無有效的治療藥物和措施。TDI01在塵肺模型中具有明顯改善病理評分和肺功能的作用,集團將積極推進TDI01人體臨牀試驗的進程。

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