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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: 31 Mar 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

    • 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
    • 13 Jul 2023 According to a Harbour BioMed media release,the company announced the acceptance of Biologics License Application (BLA) submission by National Medical Products Administration in China.
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