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石藥集團(01093.HK):SYH2046片獲美國臨牀試驗批準

格隆匯5月9日丨石藥集團(01093.HK)公告,集團開發的化藥1類新藥SYH2046片("該產品")已獲得美國食品藥品監督管理局(FDA)批準,可以在美國開展臨牀試驗。

該產品亦已於2025年4月獲得中華人民共和國國家藥品監督管理局批準,可以在中國開展臨牀試驗。該產品是一款具有完全自主知識產權的全新結構first-in-class小分子藥物,本次獲批的臨牀試驗適應症爲急性心肌梗死後心力衰竭。臨牀前研究表明,該產品可顯著改善疾病動物模型的心臟功能並降低心臟不良重構,且具有較高的安全性。

與傳統心衰藥物相比,該產品具有全新作用機制,有望通過改善心臟細胞的代謝,在心肌損傷早期積極促進組織修復,以增強心肌梗死後的心臟功能,具有較大的臨牀開發價值。目前,集團已在國內外提交該產品的多項專利申請。

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