Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults.
Drug Profile
Ivarmarcitinib is a highly selective JAK1 inhibitor for external use. It better inhibits JAK1 signaling through high local exposure, exerting anti-inflammatory and immune suppressive effects. Globally, similar products approved for AD include Incyte/CMS’ Opzelura (ruxolitinib) cream and Japan Tobacco/Torii Pharma’s Corectim (delgocitinib) ointment.
Clinical Trial Results
The Phase III study for ivarmacitinib met its co-primary endpoint in September 2024. The drug demonstrated significant improvement over the excipient in terms of the co-primary endpoint and showed a good safety and tolerability profile in long-term treatment of adult patients with AD. Additionally, no new safety signals were identified compared with other JAK1 inhibitors.-Fineline Info & Tech
