Drug intelligence / Profile preview

stapokibart

Development stage
Phase 4
Lead developer
Keymed Biosciences
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Stapokibart is a high-efficiency, humanized monoclonal antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). By binding to IL-4Rα, it blocks both interleukin‑4 (IL‑4) and interleukin‑13 (IL‑13) signaling pathways, which are central to type II inflammation. Stapokibart is approved in China for the treatment of moderate-to-severe atopic dermatitis in adults inadequately controlled by topical medications or for whom such medications are not indicated. It is also approved for chronic rhinosinusitis with nasal polyposis and seasonal allergic rhinitis. The drug has demonstrated good safety and efficacy in multiple clinical trials and represents the first domestically manufactured IL‑4Rα antibody therapy granted marketing approval by China's NMPA[2][3][5][6][8].

Brand names
Kangyueda康悦达
Other names
Immunoglobulin G4 [227-proline], anti-(human interleukin 4 receptor subunit α) (human-Mus musculus monoclonal CM310 γ4-chain), disulfide with human-Mus musculus monoclonal CM310 κ-chain, dimer
02

Targets

IL4R (Interleukin-4 receptor alpha subunit)

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