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    DRUG:

    Boyoubei (denosumab biosimilar)

    i
    Other names: LY01011, LY 01011, LY06006, BA1102, BA6101
    Associations

    News

    Trials
    Company:
    Luye Group
    Drug class:
    RANK ligand inhibitor
    Related drugs:
    Associations

    News

    Trials
    7ms
    Comparative Efficacy, Safety, PK, and Immunogenicity Study (clinicaltrials.gov)
    P3, N=392, Active, not recruiting, Luye Pharma Group Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Prolia (denosumab) • Boyoubei (denosumab biosimilar)
    1year
    A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection (clinicaltrials.gov)
    P1, N=300, Completed, Luye Pharma Group Ltd.
    New P1 trial
    |
    Prolia (denosumab) • Boyoubei (denosumab biosimilar)
    1year
    A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects. (PubMed, J Bone Oncol)
    No neutralizing antibody (Nab) was detected in either group throughout the study. The study demonstrated PK and PD similarity of LY01011, a denosumab biosimilar, to denosumab in healthy Chinese subjects, with comparable safety and immunogenicity profiles.
    Clinical • Journal
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    Boyoubei (denosumab biosimilar)