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Batoclimab - HanAll Biopharma/Harbour BioMed/Immunovant

Drug Profile

Batoclimab - HanAll Biopharma/Harbour BioMed/Immunovant

Alternative Names: Anti-FcRn monoclonal antibody; Anti-hFcRn mAb; HBM-9161; HL-161; HL-161BKN; HL-61; IMVT 1401; RVT 1401

Latest Information Update: 26 Mar 2024

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At a glance

  • Originator HanAll Biopharma
  • Developer HanAll Biopharma; Harbour BioMed; Immunovant
  • Class Antianaemics; Antineoplastics; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Neonatal Fc receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Myasthenia gravis
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Myasthenia gravis
  • Phase III Graves ophthalmopathy
  • Phase II/III Idiopathic thrombocytopenic purpura
  • Phase II Autoimmune haemolytic anaemia; Chronic inflammatory demyelinating polyradiculoneuropathy
  • Phase I/II Neuromyelitis optica
  • Preclinical Pemphigus vulgaris; Polycythaemia vera
  • Suspended Autoimmune disorders

Most Recent Events

  • 21 Mar 2024 Phase-III clinical trials in Graves ophthalmopathy in Japan (SC)
  • 21 Mar 2024 Harbour BioMed plans to re-submit the Biologics License Application (BLA) for batoclimab for Myasthenia gravis to the National Medical Products Administration (NMPA) of China, in 1H of 2024
  • 21 Mar 2024 Immunovant announces approval of clinical trial notification (CTN) to initiate a phase III trial in Graves ophthalmopathy in Japan (SC)
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