四環醫藥(00460.HK)：軒竹生物藥品XZP-6019獲批進行非酒精性脂肪性肝病臨牀試驗
格隆匯9月7日丨四環醫藥(00460.HK)發佈公吿，軒竹生物收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》，同意軒竹生物自主研發的XZP-6019藥品進行非酒精性脂肪性肝病(Non-alcoholic Fatty Liver Disease)(“NAFLD”)的臨牀試驗。
根據披露，NAFLD是指與胰島素抵抗和遺傳易感性密切相關的代謝應激性肝臟損傷。可從單純性脂肪肝經非酒精性脂肪性肝炎(NASH)發展為肝纖維化，甚至導致肝硬化、肝細胞癌或肝功能衰竭等終末期肝病。NAFLD不僅可以導致肝病殘疾和死亡，還與代謝綜合徵、2型糖尿病、動脈硬化性心血管疾病以及結直腸腫瘤等疾病的高發密切相關。隨着肥胖和代謝綜合徵的流行，中國NAFLD患者人數接近2.4億，NAFLD已成為中國第一大慢性肝病和健康體檢肝臟生物化學指標異常的首要原因。同時也發現越來越多的乙型肝炎病毒(HBV)慢性感染者合併NAFLD，嚴重危害人民生命健康。
在歐美等國家，非酒精性脂肪肝病發病率為20%–30%，是慢性肝病的首因，其中僅美國NAFLD人羣達到6,500萬人。在中國其發病率僅次於病毒性肝炎，居第2位，且近年來中國的發病率呈上升趨勢，在肝病疾病中，非酒精性肝病的比例達到了49.3%。NAFLD患者中約10%–20%會發展成非酒精性肝炎(NASH)，若不加以控制，20%的NASH病人在10年內會發展成肝硬化。針對代謝性疾病相關的肝損傷疾病，全球存在巨大、未滿足的臨牀需求，預計到2025年中美NASH藥物治療市場空間將達到240億美元。目前尚無治療NAFLD相關藥品在美國食品藥物管理局、歐盟EMA(歐洲藥品管理局)及中國批准上市。
臨牀前研究數據顯示XZP-6019優於同類藥物，可以顯著改善動物模型中的NAFLD及NASH表現，直接或間接改善胰島素抵抗，改善脂肪變、氣球樣變及炎症。XZP-6019起效劑量低，吸收快，藥代性質良好；對中樞系統、神經系統和心血管系統無不良影響，安全性優異。XZP-6019是軒竹生物成功獲批臨牀研究的第16個1類創新藥，也是首個同類靶點在中國進行臨牀試驗的藥物。
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