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FB 825

Drug Profile

FB 825

Alternative Names: Anti-CemX; Anti-CEmX monoclonal antibody - Fountain Biopharma; Anti-CEmX monoclonal antibody - Oneness Biotech; FB-825; FB825-15D11; h4B12; LP0201

Latest Information Update: 13 Feb 2024

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At a glance

  • Originator Academia Sinica
  • Developer Fountain BioPharma; Oneness Biotech
  • Class Anti-inflammatories; Antiallergics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Apoptosis stimulants
  • Orphan Drug Status

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

    Yes - Job syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Allergic asthma; Atopic dermatitis; Job syndrome
  • No development reported Allergic rhinitis

Most Recent Events

  • 30 Jan 2024 Oneness Biotech files an IND application with the US FDA in the US for phase II trial in Atopic dermatitis
  • 30 Jan 2024 Oneness biotech plans a phase II trial for Atopic dermatitis in the US (SC)
  • 03 May 2023 Phase-I clinical trials in Atopic dermatitis (In volunteers) in USA (SC) (NCT05952986)
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