11月25日，信达生物（01801）发布公告，宣布其高剂量9mg的玛仕度肽注射液上市申请已获得中国国家药品监督管理局药品审评中心受理。该产品主要用于成人中重度肥胖患者的长期体重控制。
公告中提到，玛仕度肽在中国中重度肥胖人群中的III期注册临床研究GLORY-2显示出卓越的结果，研究中玛仕度肽9mg组受试者在第60周时平均体重降幅为18.55%，而安慰剂组仅为3.02%。此外，玛仕度肽9mg组中有44.0%的受试者实现20%及以上的体重降幅，安慰剂组这一比例为2.6%（P值均小于0.0001）。
研究还显示，玛仕度肽9mg组受试者的肝脏脂肪含量平均百分比降幅达到71.9%，并在血压、血脂、血尿酸等关键心血管代谢指标上表现出显著改善。该药物的安全性良好，未发现新的安全性信号。玛仕度肽作为GLP-1类药物，已在多项临床研究中展现出良好的减重和降糖疗效，并为不同疾病严重程度的肥胖患者提供个性化的解决方案。
（文章来源：财中社）
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