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Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study

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Trial Profile

Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2026

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At a glance

  • Drugs Aflibercept (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Therapeutic Use
  • Sponsors Mabwell (Shanghai) Bioscience

Most Recent Events

  • 04 Jun 2026 Accoridng to a Mabwell media release, Results from the Phase III clinical study of 9MW0813 (aflibercept biosimilar) in diabetic macular edema (DME) were presented by Professor Wei Wenbin from Beijing Tongren Hospital, Capital Medical University.
  • 20 Sep 2025 Accoridng to a Mabwell media release, New Drug Application for 9MW0813 injection has been accepted by the National Medical Products Administration (NMPA) for the treatment of diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).
  • 13 Apr 2022 New trial record

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