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SYH2059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。此前，该产品已于2025年1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。
该产品由集团小分子药物创新设计平台研发，是一款全新的、具有完全自主知识产权的高活性与高选择性的环核苷酸磷酸二酯酶4B(PDE4B)抑制剂。本次获批的临床适应症为间质性肺疾病。临床前研究表明，该产品对PDE4B靶点的选择性和活性均显著优于同靶点药物，在疾病动物模型上的药效亦明显优于现有药物，且具有良好的药代动力学特征和安全性。
目前市场上治疗间质性肺疾病的药物为数不多，且患者治疗获益有限，该产品有望成为该疾病的有效治疗药物，具有较大临床开发价值。
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