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Omalizumab biosimilar - Synermore Biologics

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Drug Profile

Omalizumab biosimilar - Synermore Biologics

Alternative Names: Kelingda; SYN-008

Latest Information Update: 23 Jan 2025

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At a glance

  • Originator Synermore Biologics
  • Developer CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.; Synermore Biologics
  • Class Antiallergics; Antiasthmatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action IgE receptor antagonists; Immunosuppressants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Chronic urticaria
  • Phase III Allergic asthma
  • No development reported Asthma

Most Recent Events

  • 21 Jan 2025 No development reported - Phase-III for Chronic-urticaria (Treatment-experienced) in Hungary (SC)
  • 17 Jan 2025 Phase-III clinical trials in Allergic asthma is ongoing in China (SC)
  • 16 Aug 2021 Phase-III clinical trials in Chronic-urticaria (Treatment-experienced) in Hungary (SC) (EudraCT2021-000149-42)

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