联邦制药附属公司创新药UBT251注射液获FDA批准开展II期临床试验

财中社
04 Mar

  3月4日,联邦制药(03933)发布公告,近日公司全资附属公司联邦生物科技(珠海横琴)有限公司自主研发的1类创新药UBT251注射液获得美国药品监督管理局(FDA)批准,允许开展慢性肾脏病(CKD)适应症的II期临床试验。此前,该适应症已于2025年1月20日获得中国国家药品监督管理局的临床试验批准。

  UBT251是一款长效GLP-1/GIP/GCG三靶点受体激动剂,公司的研发成果在临床前肥胖/糖尿病肾病药效模型中表现出明显优于司美格鲁肽的效果,尤其在改善肾脏尿白蛋白等相关肾损伤标志物和组织病理方面。

  未来,该药物有望为代谢相关慢性肾病的治疗提供新选择,进一步满足临床用药需求。公司表示将持续致力于新产品研发,提升在生物医药行业的竞争力和创造力,为公司及其股东创造更大收益。

(文章来源:财中社)

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