Drug intelligence / Profile preview

handayuan

Development stage
Phase 3
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

HANDAYUAN is a biosimilar of adalimumab, a fully human monoclonal IgG1 antibody that acts as an immunomodulating agent by inhibiting tumor necrosis factor alpha (TNF-α). It is developed and manufactured by Shanghai Henlius Biotech. HANDAYUAN was first approved in China in December 2020 for the treatment of autoimmune diseases including rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, and uveitis. Subsequent approvals expanded its indications to include polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease (including pediatric), covering all indications of the originator adalimumab (Humira) in China. The drug is administered as a subcutaneous injection and has demonstrated high similarity to the originator product in terms of quality, safety, and efficacy through head-to-head comparison studies[1][2][5][6].

Brand names
HANDAYUAN
Other names
Han Da YuanHandayuanHLX-03HLX03HLX 03
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))

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