信立泰(002294.SZ)：JK07的HFrEF適應症在美I期臨牀第一組試驗揭盲
格隆匯3月7日丨信立泰(002294.SZ)公佈，近日，公司收到全資孫公司美國Salubris Biotherapeutics, Inc.(簡稱“美國 Salubris”)的通知，其已獲得美國FDA開展JK07慢性心力衰竭的HFpEF(射血分數保留的心衰)適應症的I期臨牀試驗資格。同時，JK07的HFrEF(射血分數減少的心衰)適應症在美國開展的I期臨牀第一組試驗揭盲，並取得早期的初步試驗數據。
JK07的I期臨牀試驗為隨機、雙盲、安慰劑對照、劑量遞增研究。I期臨牀第一組受試者(n=5)的試驗數據初步表明，與安慰劑組相比，JK07具有良好的安全性和潛在的臨牀獲益信號，左心室射血分數絕對值相對基線最大改善達到18%(相對改善大於50%)。目前，美國Salubris正進行第二組臨牀試驗的入組工作。
JK07(中國項目代碼：SAL007，重組人神經調節蛋白1-抗HER3抗體融合蛋白注射液，簡稱“07”)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，2020年9月獲得中國CDE的臨牀試驗批准，目前正在美國、中國同時開展I期臨牀試驗。
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。07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，07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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