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Batoclimab - HanAll Biopharma/Harbour BioMed/Immunovant

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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: 12 Sep 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; Graves' disease
  • Phase I/II Neuromyelitis optica
  • Preclinical Pemphigus vulgaris; Polycythaemia vera
  • Suspended Autoimmune disorders

Most Recent Events

  • 09 Sep 2024 Efficacy data from phase II trial for Graves ophthalmopathy released by Immunovant
  • 08 Aug 2024 Immunovant expects to have at least 3 IND applications active by the end of calendar year 2024
  • 06 Aug 2024 Immunovant completes enrolment in its Phase-III clinical trials in Myasthenia gravis in the US, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, South Korea, Mexico, Poland, Romania, Serbia, Spain and the UK (SC, Injection) (NCT05403541)

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