智通财经APP讯，石药集团(01093)发布公告，集团开发的SYH2046片已获得中国国家药品监督管理局批准，可在中国开展临床试验。
该产品是一款具有完全自主知识产权的全新结构first-in-class小分子药物，本次获批的临床试验适应症为急性心肌梗死后心力衰竭。临床前研究表明，该产品可显着改善疾病动物模型的心脏功能并降低心脏不良重构，且具有较高的安全性。
急性心肌梗死是指各种原因造成的冠状动脉供血减少或完全中断，相应心肌出现严重而持久的急性缺血，导致心肌细胞坏死。急性心梗是引发心力衰竭的重要原因，急性心梗后心力衰竭的发生率为14%–36%，心衰住院患者5年病死率可达42.3%。心衰难治疗，预后差，患者死亡率高，传统治疗药物效果并不理想。
与传统心衰药物相比，该产品具有全新作用机制，有望通过改善心脏细胞的代谢，在心肌损伤早期积极促进组织修复，以恢复心肌梗死后的心脏功能，具有较大的临床开发价值。
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