智通财经APP讯，石药集团(01093)发布公告，集团开发的化药1类新药SYH2046片(该产品)已获得美国食品药品监督管理局(FDA)批准，可以在美国开展临床试验。该产品亦已于2025年4月获得中华人民共和国国家药品监督管理局批准，可以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。
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，以增强心肌梗死后的心脏功能，具有较大的临床开发价值。目前，本集团已在国内外提交该产品的多项专利申请。
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