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