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The global Phase III clinical study of JHL1149 in patients with non-small cell lung cancer (NSCLC)

Trial Profile

The global Phase III clinical study of JHL1149 in patients with non-small cell lung cancer (NSCLC)

Planning
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2018

At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors JHL Biotech
  • Most Recent Events

    • 16 Oct 2018 National Medical Products Administration of the PRC (NMPA) has approved Phase I and Phase III Clinical Trial Application for JHL1149.
    • 23 Aug 2018 New trial record
    • 09 Aug 2018 According to a JHL Biotech media release, the EMA confirmed it agrees with JHL's development approach, clinical development proposal and design of this phase 3 study. Based on the EMA's review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully.
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