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四環醫藥(00460.HK)附屬復達那非獲肺動脈高壓適應症臨牀試驗批件
格隆匯 09-01 12:27

格隆匯9月1日丨四環醫藥(00460.HK)宣佈,公司附屬軒竹生物自主研發的全新PDE-5抑制劑復達那非(“復達那非”)獲得肺動脈高壓(“PAH”)適應症的臨牀試驗批件,用於治療成人動脈性肺動脈高壓,以改善運動能力和延緩臨牀惡化。

PAH是以肺動脈壓力增高病變為特徵的惡性肺血管疾病,隨着患者肺部血管阻力的持續性升高,最終可導致心臟和呼吸衰竭。PDE-5抑制劑作為治療肺動脈高壓的靶向藥物之一,因其良好的安全性和明確的療效曾在多部國內外PAH治療指南中被推薦為首選藥物。今年,PDE-5抑制劑聯合內皮素受體拮抗劑(ERA)被推薦為PAHWHOII/III級患者的初治治療方案,在改善臨牀症狀,逆轉病理表現中均有不錯表現。復達那非作為軒竹生物自主研發的全新PDE-5抑制劑,對於動脈性肺動脈高壓疾病的治療機制明確,在前期的臨牀前藥效學研究中顯示了優異的療效。

據測算,PAH在中國的發病率約1%,65歲以上人羣的發病率可高達約5%至10%,而中國有約1,200萬人受到肺動脈高壓疾病的困擾。2020年,全球肺動脈高壓藥物銷售額在40億美元左右。各指南推薦安立生坦及他達拉非聯合治療肺動脈高壓,但目前西地那非是中國國內唯一獲批治療PAH的PDE-5抑制劑,對於聯合用藥尚有比較大的臨牀需求。

PDE-5抑制劑在治療勃起功能障礙及肺動脈高壓適應症方面均有較高的市場地位,西地那非2020年市場規模約為16.6億美元,他達拉非約為16.8億美元。在中國城市零售藥店終端,西地那非是泌尿系統化藥TOP1品種,2019年銷售額超過23億元,他達拉非銷售額近7億元。

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