智通财经APP讯，石药集团(01093)发布公告，本集团自主研发的化学1类新药SYH2068注射液(双链小干扰RNA (si RNA)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，可以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(Gal NAc)实现肝脏靶向递送的si RNA 药物，以皮下给药的方式靶向脂蛋白(a) [Lp (a)]，能有效降低Lp (a)水平。该产品适用于治疗高脂蛋白(a)血症，通过优化序列和化学修饰的策略来实现更持久的基因沉默效果，有望成为超长效降低 Lp (a)的si RNA药物，具有预防动脉粥样硬化性心血管疾病(ASCVD)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优于同类型si RNA产品，展现出药物作用效果持久、安全性好、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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