Jiangsu Hengrui Medicine Co. Ivarmacitinib sulfate: Chinese prescribing information. 2025. https://www.hengrui.com/. Accessed 21 Apr 2025.
Chikhoune L, Poggi C, Moreau J, et al. JAK inhibitors (JAKi): mechanisms of action and perspectives in systemic and autoimmune diseases. Rev Med Interne. 2025;46(2):89–106.
Virtanen A, Kettunen V, Musta K, et al. Molecular basis of JAK kinase regulation guiding therapeutic approaches: evaluating the JAK3 pseudokinase domain as a drug target. Adv Biol Regul. 2025;95: 101072.
Article PubMed CAS Google Scholar
Reistone Biopharma. Reistone Biopharma, a new Chinese biotech company ready to initiate its ulcerative colitis phase II clinical trial globally [media release]. 22 Oct 2018. https://www.biospace.com/.
Jiangsu Hengrui Medicine Co Ltd, Arcutis Pharmaceuticals. Jiangsu Hengrui Medicine and Arcutis announce a development and commercialization partnership for novel immune-mediated dermatology therapy using SHR0302 [media release]. 5 Jan 2018. https://www.biospace.com/.
National Medical Products Administration. NMPA Approval: ivarmacitinib sulfate. 2025. https://www.nmpa.gov.cn/. Accessed 21 Apr 2025.
Jiangsu Hengrui Pharmaceutical Co Ltd. Hengrui's innovative drug and China's first self-developed JAK1 inhibitor ivarmacitinib sulfate tablets were approved for marketing [media release]. 24 Mar 2025. https://www.hengrui.com/.
Jiangsu Hengrui Medicine Co Ltd. Hengrui's innovative drug ivarmacitinib sulfate tablets approved for new indication for rheumatoid arthritis [media release]. 2 Apr 2025. https://www.hengrui.com/.
Jiangsu Hengrui Medicine Co Ltd. The innovative drug ivarmacitinib sulfate tablets has been approved for a new indication for moderate to severe atopic dermatitis [media release]. 10 Apr 2025. https://www.hengrui.com/.
Jiangsu Hengrui Medicine Co Ltd. Hengrui Medicine's "JAK1 inhibitor" alopecia areata indication application accepted [media release]. 6 Sep 2024. https://news.yaozh.com/archive/44166.html.
Jiangsu Hengrui Medicine Co Ltd. The application for the domestic JAK1 inhibitor emasitinib ointment for atopic dermatitis has been accepted [media release]. 17 Feb 2025. https://www.hengrui.com/.
Arcutis Biotherapeutics. Arcutis announces exercise of option for exclusive license to highly selective JAK1 inhibitor for all topical dermatological uses in U.S., Canada, Europe and Japan [media release]. 13 Jan 2020. https://www.arcutis.com/.
Sun X, He Q, Yang J, et al. Preventive and therapeutic effects of a novel JAK inhibitor SHR0302 in acute graft-versus-host disease. Cell Transplant. 2021;30:9636897211033778.
Wu H, Yan S, Chen J, et al. JAK1-STAT3 blockade by JAK inhibitor SHR0302 attenuates inflammatory responses of adjuvant-induced arthritis rats and decreases Th17 and total B cells. Joint Bone Spine. 2016;83(5):525–32.
Article PubMed CAS Google Scholar
Mohammad TAM, Jaafar HM, Maroof AMA. SHR0302 improves Treg/Th17 imbalance in patients with systemic lupus erythematosus. Indian J Clin Biochem. 2025;40(2):274–83.
Article PubMed CAS Google Scholar
Ge X, Ma S, Yan S, et al. Mass balance study of [(14)C]SHR0302, a selective and potent JAK1 inhibitor in humans. Xenobiotica. 2023;53(2):69–83.
Article PubMed CAS Google Scholar
Fu M, Luo L, Feng S, et al. Effect of SHR0302 on the pharmacokinetics of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 probe substrates in healthy volunteers: a cocktail analysis. Br J Clin Pharmacol. 2023;89(12):3659–68.
Article PubMed CAS Google Scholar
Li Z, Liu X, Zhao C, et al. A multicenter, randomized, double-blind, placebo-controlled, phase 2/3 study of SHR0302, a selective janus kinase 1 inhibitor, in patients with active ankylosing spondylitis [abstract no. POS0214]. Ann Rheum Dis. 2024;83(Suppl 1):348–9.
Liu J, Jiang Y, Zhang S, et al. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025;84(2):188–200.
Article PubMed CAS Google Scholar
Zhao Y, Gooderham M, Yang B, et al. Ivarmacitinib for moderate to severe atopic dermatitis in adults and adolescents: a phase 3 randomized clinical trial. JAMA Dermatol. 2025. https://doi.org/10.1001/jamadermatol.2025.0982.
Zhao Y, Zhang L, Ding Y, et al. Efficacy and safety of SHR0302, a highly selective Janus kinase 1 inhibitor, in patients with moderate to severe atopic dermatitis: a phase II randomized clinical trial. Am J Clin Dermatol. 2021;22(6):877–89.
Article PubMed PubMed Central Google Scholar
Li B, Goh JSH, Wang D, et al. A highly selective Janus kinase 1 inhibitor, ivarmacitinib ointment, for the treatment of atopic dermatitis: results from a phase II study [abstract no. P081]. Br J Dermatol. 2024;192(Suppl 1):i52–3.
Jiangsu Hengrui Medicine Co Ltd. 2025 AAD oral report. Results of phase III study of domestic JAK1 inhibitor ivarmacitinib sulfate tablets in the treatment of severe alopecia areata in adults released [media release]. 12 Mar 2025. https://www.hengrui.com/.
Zhou C, Yang X, Yang B, et al. A randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of ivarmacitinib (SHR0302) in adult patients with moderate-to-severe alopecia areata. J Am Acad Dermatol. 2023;89(5):911–9.
Article PubMed CAS Google Scholar
Chen B, Zhong J, Li X, et al. Efficacy and safety of ivarmacitinib in patients with moderate-to-severe, active, ulcerative colitis: a phase II study. Gastroenterology. 2022;163(6):1555–68.
Article PubMed CAS Google Scholar
He Q, Sun X, Niu J, et al. A novel JAK1 inhibitor SHR0302 combined with prednisone for first-line treatment of chronic graft-versus-host disease: a phase I clinical trial. Cell Transplant. 2024;33:1–11.
Arcutis Biotherapeutics. Arcutis completes enrollment of phase 1b alopecia areata study evaluating ARQ-255 [media release]. 5 Sep 2024. https://www.arcutis.com/.
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