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 1401Latest Information Update: 26 Mar 2024
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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)