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Stapokibart - KeyMed Biosciences/Shanghai JMT-BIO Technology

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Drug Profile

Stapokibart - KeyMed Biosciences/Shanghai JMT-BIO Technology

Alternative Names: Anti-IL-4Rα recombinant fully humanized antibody - KeyMed Biosciences; CM-310; CM310 Recombinant humanized monoclonal antibody injection; IL-4Rα(mAb) - KeyMed Biosciences; Kangyueda

Latest Information Update: 16 Sep 2024

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At a glance

  • Originator KeyMed Biosciences
  • Developer KeyMed Biosciences; Shanghai JMT-BIO Technology
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Interleukin 4 receptor alpha subunit antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Atopic dermatitis
  • Preregistration Allergic rhinitis; Rhinosinusitis
  • Phase III Prurigo nodularis
  • Phase II/III Asthma; Chronic obstructive pulmonary disease

Most Recent Events

  • 12 Sep 2024 Registered for Atopic dermatitis in China (SC) - First Global Approval
  • 27 Aug 2024 Phase-II/III clinical trials in Chronic obstructive pulmonary disease (Treatment-experienced) (SC) prior to August 2024 (NCT06547333)
  • 09 Aug 2024 CSPC Pharmaceutical Group plans a phase II/III trial for Chronic obstructive pulmonary disease (Treatment-experienced) in September 2024 (SC, Injection) (NCT06547333)

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