石药集团(01093):SYH2070注射液(双链小干扰RNA药物)在中国获临床试验批准

智通财经
Yesterday

智通财经APP讯,石药集团(01093)发布公告,集团自主研发的化学1类新药SYH2070注射液(双链小干扰RNA(siRNA)药物)(该产品)已获得中华人民共和国国家药品监督管理局批准,可在中国开展临床试验。

该产品是一款通过偶联乙酰半乳糖胺(GalNAc)实现肝脏靶向递送的siRNA药物,以皮下给药的方式靶向血管生成素样蛋白3(ANGPTL3),能有效降低ANGPTL3水平。通过优化序列和化学修饰的策略,该产品实现更持久的基因沉默效果,有望成为超长效降低ANGPTL3 的siRNA药物,适用于治疗高甘油三酯血症或混合型高脂血症,具备有效降低残余胆固醇水平升高风险的潜力。

临床前研究显示,该产品在药物活性和药效持续性方面均优于同类型siRNA产品,展现出药物作用效果持久、安全性良好、患者依从性高等差异化优势,具有较高的临床开发价值。

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