石药集团(01093)发布公告，集团开发的化药1类新药强效醛固酮合成酶抑制剂( SYH2072片)(该产品)已获得美国食品药品监督管理局批准，可在美国开展临床试验。该产品亦已于2025年12月获得中华人民共和国国家药品监督管理局批准在中国开展临床试验。
该产品是一种高选择性强效醛固酮合成酶抑制剂(ASI)，可有效降低血浆醛固酮水平，且不影响皮质醇水平。本次获批的临床适应症为未控制高血压和难治性高血压。临床前研究显示，该产品可选择性抑制醛固酮合成酶的活性，在动物疾病模型中显著降低血浆醛固酮水平，并剂量依赖性地降低高血压模型的血压，同时不影响皮质醇水平。该产品具有良好的药代动力学(PK)特性和安全性，使其具备成为一款同类最优(best-in-class)药物的潜力。目前，集团已在国内外提交了该产品的多项专利申请。
鉴于醛固酮合成酶抑制剂的临床需求广阔，该产品具有较高的临床开发价值，有望为未控制高血压和难治性高血压患者提供新的治疗选择。
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