石药集团(01093):度普利尤单抗注射液在中国获临床试验批准

智通财经
Aug 19, 2025

智通财经APP讯,石药集团(01093)发布公告,本集团开发的度普利尤单抗注射液(该产品)已获中国国家药品监督管理局批准,可在中国开展临床试验。

该产品是一种靶向IL-4Rα的重组全人源单克隆抗体药物,为达必妥®的生物类似药,按照治疗用生物制品3.3类申报,适用于治疗成人中重度特应性皮炎。

该产品的研发遵循生物类似药相关研究指南。药学及非临床研究结果显示,该产品与原研参照药在质量、安全性和有效性方面高度相似,支持开展后续临床研究。

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