诺诚健华注射用坦昔妥单抗上市申请获批

财中社
May 21, 2025

  5月21日,诺诚健华(688428/09969)发布公告,公司收到国家药品监督管理局的通知,坦昔妥单抗(tafasitamab)联合来那度胺治疗复发/难治性弥漫性大B细胞淋巴瘤的上市申请获得批准。这是中国首个获批治疗该病症的CD19单抗,标志着公司在血液瘤领域的重要进展。

  公告中提到,坦昔妥单抗是一款靶向CD19的单克隆抗体,适用于不适合自体干细胞移植的成人患者。此外,坦昔妥单抗联合来那度胺在中国香港、中国澳门和中国台湾地区也已获批用于治疗符合条件的患者,显示出其在多个地区的应用潜力。

  2025年一季度,诺诚健华实现收入3.81亿元,归母净利润1797万元。

(文章来源:财中社)

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