和铂医药-B(02142)B7H4×CD3双抗HBM7004获国家药监局临床试验批准

公告速递
Aug 18

2026年8月18日,和铂医药控股有限公司(02142)(下称“公司”或“和铂医药-B”)发布自愿公告称,其新型B7H4×CD3双特异性抗体HBM7004治疗晚期实体瘤的新药临床试验(IND)申请已获中国国家药品监督管理局批准。

公告显示,HBM7004基于公司自研HBICE®平台开发,旨在通过B7H4依赖性T细胞激活机制提供差异化的肿瘤免疫治疗方案。在多种动物模型的临床前研究中,该药物表现出强劲抗肿瘤效果、出色的体内稳定性以及较低全身毒性;与B7H4×4-1BB双抗联用时,在低效应/靶细胞比例条件下展现出显著协同作用。

此次获批系继2026年5月8日美国食品药品监督管理局批准HBM7004在美开展首次人体I期临床试验后,项目迎来的又一里程碑。公司在公告中重申,目前无法保证HBM7004能最终成功开发或上市,提醒股东及潜在投资者买卖公司股份时保持审慎。

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