AstraZeneca files for approval in China for new systemic lupus erythematosus drug

Aug 20, 2025 11:54 CST Updated Sep 05, 10:47

On August 20, the website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) showed that AstraZeneca's avacopan injection has been accepted for marketing authorization application, intended for the treatment of systemic lupus erythematosus (SLE).

AvelumabYesa first-in-classFully human monoclonal antibody, targeting type I interferon receptor 1 (IFNAR1), thereby blocking type IInterferon activity.IFNAR1 and IFNAR2 can form a heterodimeric receptor (IFN-α/β receptor).is a cytokine involved in regulating the SLE inflammatory pathway and plays a central role in its pathophysiology, Type IInterferon receptorIncreased signal is associated with increased disease activity and severity.

August 2021,AvelumabFirst approved by the FDA for the treatment of adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Data from multiple registrational clinical studies (includingPhase III TULIP-1, TULIP-2 studies and Phase II MUSE study) indicates that, compared with placebo, on the basis of standard therapy,AvelumabGroup more patients achieving organ system (Including skin and joints) overall disease activity reduction, along with oral corticosteroids (OCS) continues to decline in use.

In the TULIP-2 trial, avacopan significantly improved the BILAG-based Composite Lupus Assessment (BICLA).

According to the医药魔方database, two other domestic IFNAR-1 monoclonal antibodies have entered the clinical stage, developed by GenScript Biotech and Quanxian Biopharma, respectively.

If Avelumab is approved smoothly, it is expected to benefit moreprovides a new treatment option for patients with systemic lupus erythematosus.