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A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2024

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At a glance

  • Drugs Batoclimab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Sponsors Harbour BioMed; Ligand Pharmaceuticals

    • Most Recent Events

    • 26 Jun 2024 According to Harbour BioMed media release, the Company completed the extension period for the Phase III clinical trial to collect additional long-term safety data without enrolling new patients. As a result, the Company voluntarily included this additional safety data and resubmitted the the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG) as planned.
    • 21 Mar 2024 According to HanAll media release, Harbour BioMed plans to include the supplementary long-term safety data and aims to re-submit the BLA for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024.
    • 21 Mar 2024 According to OmniAB media release , the company announced that topline data will be published in the second half of 2024
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