石药集团1类新药SYH2046获FDA批准开展临床试验

财中社2025-05-09

5月9日，石药集团（01093）发布公告，宣布其开发的化药1类新药SYH2046片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。该产品也已于2025年4月获得中国国家药品监督管理局的批准，允许在中国进行临床试验。SYH2046片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，主要适应症为急性心肌梗死后心力衰竭。临床前研究显示，该产品能够显著改善疾病...

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