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中國生物製藥(01177.HK):吸入用TQC3721混懸液“PDE3/4抑制劑”獲CDE批準開展III期註冊臨牀研究

格隆匯6月9日丨中國生物製藥(01177.HK)公告,集團開發的1類創新藥吸入用TQC3721混懸液「PDE3/4抑制劑」已獲得中國國家藥品監督管理局藥品審評中心(CDE)批準開展III期註冊臨牀研究,用於慢性阻塞性肺疾病(COPD)的維持治療。

TQC3721是一款全新機制的吸入性PDE3/4抑制劑,具有支氣管擴張和抗炎的雙重作用,從而減輕患者症狀,並抑制炎症,控制疾病進展。臨牀研究結果顯示,TQC3721在單支氣管擴張劑(單支擴)和雙支氣管擴張劑(雙支擴)背景治療的COPD患者中,支擴效應和聖喬治評分有顯著改善,療效優於同靶點藥物,相關數據將在近期國際學術會議上公佈。本項III期臨牀研究將在更大樣本的中重度COPD患者中,進一步觀察在不同背景治療(無背景、單支擴或雙支擴)下使用吸入用TQC3721混懸液的有效性和安全性。

目前,全球僅一款吸入性PDE3/4抑制劑獲批上市,TQC3721研發進度全球排名第二。相較於已上市產品,TQC3721的III期臨牀試驗將額外納入雙支擴背景治療患者,覆蓋更爲廣泛的COPD患者人羣。此外,除吸入用混懸液外,TQC3721吸入粉霧劑正處在臨牀I期開發階段,乾粉劑型有望進一步提升患者的依從性。

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