港股异动 | 信达生物(01801)涨超3% 口服小分子GLP-1R激动剂IBI3032的IND获美国FDA批准

智通财经
Aug 05

智通财经APP获悉,信达生物(01801)涨超3%,截至发稿,涨3.12%,报95.8港元,成交额2.19亿港元。

消息面上,据信达生物官微消息,8月5日,公司宣布其研发的创新口服小分子GLP-1R激动剂IBI3032获美国食品药物监督管理局(FDA)新药临床试验申请(IND)批准。

据介绍,IBI3032为信达生物自主研发的口服小分子GLP-1R激动剂,偏向性激活cAMP信号通路,基于全球目前成熟验证的分子骨架且具有完全自主知识产权。IBI3032的I期临床试验将在中美同步推进,将于2025年下半年开始在健康受试者及超重或肥胖人群中给药。信达生物正在迅速以玛仕度肽为基石在代谢管线进行布局拓展,IBI3032临床研究启动是代谢产品矩阵进化的重要一步。

目前,IBI3032的新药临床试验申请(IND)已经获得中国国家药品监督管理局(NMPA)受理和美国FDA食品药物监督管理局(FDA)批准,计划将在2025年下半年启动中美I期临床研究。

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10