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天士力(600535.SH):B1344注射液獲得美國FDA臨牀試驗許可
格隆匯 01-25 16:09

格隆匯1月25日丨天士力(600535.SH)公佈,日前,公司控股子公司天士力生物醫藥股份有限公司(以下簡稱“天士力生物”)收到美國食品藥品監督管理局(以下簡稱“FDA”)關於同意B1344注射液用於非酒精性脂肪性肝炎(NASH)進行臨牀試驗的函。

B1344注射液是由天士力生物研究開發的用於治療NASH的創新生物藥。B1344是聚乙二醇化的重組人成纖維細胞生長因子21突變體,通過與共受體β-klotho蛋白與成纖維細胞生長因子受體(FGFR)結合,激活下游信號分子通路,參與多個糖脂代謝疾病的病理生理過程。

臨牀前動物藥效實驗結果顯示,B1344可以顯著降低模型動物的肝臟脂肪變性、氣球樣變性和肝小葉炎症程度,改善非酒精性脂肪性肝病活動度積分評分和纖維化,降低血清谷丙轉氨酶及穀草轉氨酶水平,提示B1344在NASH患者中具有類似的臨牀獲益潛力。天士力生物於日前獲得FDA關於B1344注射液的臨牀試驗許可。截至公吿日,天士力生物關於B1344注射液的累計研發投入為人民幣7971.51萬元。

根據公開資料,目前治療NASH同靶點的成纖維細胞生長因子21(FGF21)類產品全球最高開發階段為IIb期臨牀,其臨牀數據顯示FGF21類產品兼具肝病療效、合併疾病療效和耐受性好的特點。後續公司產品若經研發、審批併成功上市,將為NASH患者提供安全有效的治療藥品。

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