{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T17:49:36Z","timestamp":1790790576338,"version":"4.1.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T00:00:00Z","timestamp":1742169600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T00:00:00Z","timestamp":1742169600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2025,5]]},"DOI":"10.1007\/s40265-025-02151-7","type":"journal-article","created":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T10:13:11Z","timestamp":1742206391000},"page":"715-720","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Stapokibart: First Approval"],"prefix":"10.1007","volume":"85","author":[{"given":"Matt","family":"Shirley","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,3,17]]},"reference":[{"issue":"8","key":"2151_CR1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13899","volume":"17","author":"MR McCann","year":"2024","unstructured":"McCann MR, Kosloski MP, Xu C, et al. Dupilumab: mechanism of action, clinical, and translational science. Clin Transl Sci. 2024;17(8): e13899.","journal-title":"Clin Transl Sci"},{"issue":"1","key":"2151_CR2","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1038\/nrd4624","volume":"15","author":"NA Gandhi","year":"2016","unstructured":"Gandhi NA, Bennett BL, Graham NM, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35\u201350.","journal-title":"Nat Rev Drug Discov"},{"key":"2151_CR3","unstructured":"US FDA. DUPIXENT\u00ae (dupilumab) injection, for subcutaneous use: US prescribing information. 2024. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/761055s064lbl.pdf. Accessed 22 Nov 2024."},{"key":"2151_CR4","unstructured":"European Medicines Agency. Dupixent: summary of product characteristics. 2024. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/dupixent-epar-product-information_en.pdf. Accessed 22 Nov 2024."},{"key":"2151_CR5","volume-title":"Instructions for use of stapokibart injection [in Chinese]","author":"KeyMed Biosciences","year":"2024","unstructured":"KeyMed Biosciences. Instructions for use of stapokibart injection [in Chinese]. Chengdu: KeyMed Biosciences; 2024."},{"issue":"9","key":"2151_CR6","doi-asserted-by":"publisher","first-page":"110721","DOI":"10.1016\/j.isci.2024.110721","volume":"27","author":"W Liu","year":"2024","unstructured":"Liu W, Zhao Y, He Y, et al. Stapokibart (CM310) targets IL-4R\u03b1 for the treatment of type 2 inflammation. iScience. 2024;27(9):110721.","journal-title":"iScience."},{"key":"2151_CR7","unstructured":"National Medical Products Administration. The National Medical Products Administration approved the marketing of stapokibart injection [in Chinese] [media release]. 12 Sept 2024. https:\/\/www.nmpa.gov.cn\/zhuanti\/cxylqx\/cxypxx\/20240912171529122.html?type=pc&m."},{"key":"2151_CR8","unstructured":"KeyMed Biosciences. NMPA approved the sNDA of stapokibart for the treatment of chronic rhinosinusitis with nasal polyposis [media release]. 23 Dec 2024. https:\/\/staticpacific.blob.core.windows.net\/press-releases-attachments\/3517592\/HKEX-EPS_20241223_11485842_0.PDF"},{"key":"2151_CR9","unstructured":"KeyMed Biosciences. The National Medical Products Administration approves the marketing application for a new indication of stapokibart for the treatment of seasonal allergic rhinitis [in Chinese] [media release]. 07 Feb 2025. https:\/\/staticpacific.blob.core.windows.net\/press-releases-attachments\/3528109\/HKEX-EPS_20250207_11533148_0.PDF."},{"key":"2151_CR10","unstructured":"KeyMed Biosciences. CM310 was granted Breakthrough Therapy designation by the CDE for the treatment of moderate to severe atopic dermatitis [in Chinese] [media release]. 15 Jun 2022. https:\/\/www.keymedbio.com\/show-132-196-1.html."},{"key":"2151_CR11","unstructured":"KeyMed Biosciences. Phase III clinical trial of CM310 for the treatment of chronic rhinosinusitis with nasal polyps achieved primary endpoints [in Chinese] [media release]. 27 Dec 2023. https:\/\/staticpacific.blob.core.windows.net\/press-releases-attachments\/1597610\/HKEX-EPS_20231227_11015375_0.PDF."},{"key":"2151_CR12","unstructured":"KeyMed Biosciences. The marketing authorisation application for stapokibart for the treatment of seasonal allergic rhinitis was accepted [in Chinese] [media release]. 30 Apr 2024. https:\/\/www.keymedbio.com\/show-132-212-1.html."},{"issue":"2","key":"2151_CR13","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1097\/CM9.0000000000002747","volume":"137","author":"Y Zhao","year":"2024","unstructured":"Zhao Y, Zhang J, Yang B, et al. Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 2b trial. Chin Med J (Engl). 2024;137(2):200\u20138.","journal-title":"Chin Med J (Engl)"},{"issue":"5","key":"2151_CR14","doi-asserted-by":"publisher","first-page":"984","DOI":"10.1016\/j.jaad.2024.07.1447","volume":"95","author":"Y Zhao","year":"2024","unstructured":"Zhao Y, Zhang L, Zhang J. Efficacy and safety of stapokibart (CM310) in adults with moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2024;95(5):984\u20136.","journal-title":"J Am Acad Dermatol"},{"issue":"7","key":"2151_CR15","doi-asserted-by":"publisher","first-page":"2953","DOI":"10.1007\/s12325-024-02887-w","volume":"41","author":"L Zhang","year":"2024","unstructured":"Zhang L, Zhang W, Xu Y, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of stapokibart in healthy volunteers and adult subjects with atopic dermatitis. Adv Ther. 2024;41(7):2953\u201365.","journal-title":"Adv Ther"},{"key":"2151_CR16","doi-asserted-by":"publisher","first-page":"102467","DOI":"10.1016\/j.eclinm.2024.102467","volume":"69","author":"Y Zhang","year":"2024","unstructured":"Zhang Y, Yan B, Zhu Z, et al. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. eClinicalMedicine. 2024;69:102467.","journal-title":"eClinicalMedicine."},{"key":"2151_CR17","doi-asserted-by":"publisher","first-page":"102076","DOI":"10.1016\/j.eclinm.2023.102076","volume":"61","author":"Y Zhang","year":"2023","unstructured":"Zhang Y, Yan B, Shen S, et al. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. eClinicalMedicine. 2023;61:102076.","journal-title":"eClinicalMedicine."},{"issue":"4","key":"2151_CR18","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1002\/cia2.12225","volume":"5","author":"K Kogawa","year":"2022","unstructured":"Kogawa K, Minakawa S, Matsuzaki Y, et al. Correlation between lactate dehydrogenase and other laboratory data in patients with atopic dermatitis. J Cutan Immunol Allergy. 2022;5(4):133\u20135.","journal-title":"J Cutan Immunol Allergy."},{"key":"2151_CR19","doi-asserted-by":"publisher","unstructured":"Zhao Y, Zhang L, Wu L, et al. Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial. Allergy. 2024. https:\/\/doi.org\/10.1111\/all.16368.","DOI":"10.1111\/all.16368"},{"issue":"5","key":"2151_CR20","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1007\/s40259-024-00668-z","volume":"38","author":"Y Zhao","year":"2024","unstructured":"Zhao Y, Li JY, Yang B, et al. Long-term efficacy and safety of stapokibart in adults with moderate-to-severe atopic dermatitis: an open-label extension, nonrandomized clinical trial. BioDrugs. 2024;38(5):681\u20139.","journal-title":"BioDrugs"},{"issue":"3","key":"2151_CR21","doi-asserted-by":"publisher","first-page":"118","DOI":"10.5415\/apallergy.0000000000000156","volume":"14","author":"S Shen","year":"2024","unstructured":"Shen S, Yan B, Wang M, et al. Anti-IL-4R\u03b1 monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Asia Pac Allergy. 2024;14(3):118\u201323.","journal-title":"Asia Pac Allergy"}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02151-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-025-02151-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02151-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T08:52:19Z","timestamp":1745571139000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-025-02151-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,17]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["2151"],"URL":"https:\/\/doi.org\/10.1007\/s40265-025-02151-7","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,17]]},"assertion":[{"value":"6 December 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 March 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was 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.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of Interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability"}}]}}