Stapokibart: First Approval

  

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review were offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Matt Shirley is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Stapokibart (Kangyueda^®; 康悦达^®) is a humanised IgG4 monoclonal antibody targeted against the interleukin (IL)-4 receptor alpha subunit (IL-4Rα). By binding IL-4Rα, stapokibart blocks the binding by (and subsequent signalling of) IL-4 and IL-13, two type 2 cytokines. Stapokibart is being developed by KeyMed Biosciences for the treatment of atopic dermatitis and other type 2 inflammatory diseases. In September 2024, stapokibart received its first approval, in China, for use in the treatment of moderate-to-severe atopic dermatitis in adults whose disease is poorly controlled by, or not suitable for, topical medications. Subsequently, stapokibart additionally received approval in China for use in the treatment of chronic rhinosinusitis with nasal polyps (December 2024) and for the treatment of seasonal allergic rhinitis (February 2025). Stapokibart is also under clinical evaluation for use in the treatment of moderate-to-severe asthma and chronic obstructive pulmonary disease, and prurigo nodularis. This article summarises the milestones in the development of stapokibart leading to this first approval for moderate-to-severe atopic dermatitis.

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