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信立泰(002294.SZ):“重組人神經調節蛋白1-抗HER3抗體融合蛋白注射液”獲得臨牀試驗批准通知書
格隆匯 09-18 19:24

格隆匯 9 月 18日丨信立泰(002294.SZ)公佈,近日,公司、信立泰(成都)生物技術有限公司、信立泰(蘇州)藥業有限公司收到國家藥品監督管理局核准簽發的《臨牀試驗批准通知書》,同意“重組人神經調節蛋白1-抗HER3抗體融合蛋白注射液”開展臨牀試驗,申請適應症為:治療射血分數降低的慢性心力衰竭(NYHAII-III類)。

重組人神經調節蛋白1-抗HER3抗體融合蛋白注射液(項目代碼:SAL007、JK07)是美國Salubris自主研發、具有全球知識產權的NRG-1(神經調節蛋白-1)融合抗體藥物,擬開發適應症為慢性心衰。該產品是公司第一個中美雙報的創新生物藥,於2020年2月獲得美國FDA臨牀試驗批准,目前正在美國開展人體臨牀試驗。

NRG-1是一組含有表皮樣生長因子結構域蛋白,它通過激活酪氨酸激酶蛋白受體(HER3、HER4)調控細胞生長與分化,包括對神經系統和心臟的正常發育及功能產生重要作用。SAL007分子設計獨特,解決了重組NRG-1蛋白療法的侷限性,在不影響HER4激活的情況下阻斷HER3受體功能,大幅提高了產品的成藥性和安全性。臨牀前研究結果顯示,產品具有半衰期長、安全性好的特點。在非人類靈長類動物自發性慢性心衰模型中,SAL007能夠逆轉心肌病變、顯著改善心臟收縮功能,治療效果突出,目前國內外尚無同靶點的藥物上市,具有較大的開發潛力。

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