Celltrion Terminates, Withdraws EMA Trial Application for CT-P51 Biosimilar

MT Newswires Live
07/14

Celltrion (KRX:068270) voluntarily terminated and withdrew its European Phase 3 clinical trial application for CT-P51, its biosimilar to cancer drug Keytruda, from the European Medicines Agency, according to a regulatory filing on Tuesday.

The South Korean biopharmaceutical company said the withdrawal follows changes in the global regulatory environment for biosimilar clinical trials.

The company has updated its clinical and regulatory strategy for Phase 3 trials in previously untreated metastatic non-squamous non-small cell lung cancer, reducing the number of patients recruited for the trial.

The company will continue the Phase 3 study in participating countries outside the European Union, comparing the efficacy and safety of CT-P51 against the reference drug Keytruda.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

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