智通财经APP讯,石药集团(01093)发布公告,集团开发的SYH2059片已获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。PDE4B抑制剂通过调节炎症因子的释放、抑制成纤维细胞的增殖与分化等,发挥抗炎和抗纤维化的作用。本次获批的临床适应症为间质性肺疾病( 包括但不限于特发性肺纤维化、进展性肺纤维化 )。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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