AstraZeneca's Anifrolumab Receives CDE Approval for Clinical Trials in China for Moderate to Severe Systemic Lupus Erythematosus

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that the clinical trial application for anifrolumab injection, submitted by AstraZeneca as a Class 1 therapeutic biological product, has received implicit approval. The drug is intended for the treatment of moderate-to-severe active systemic lupus erythematosus (SLE). Publicly available information indicates that anifrolumab is a monoclonal antibody that inhibits the type I interferon signaling pathway and has already entered Phase 3 clinical development outside China.

Source: CDE Official Website

Anifrolumab binds to subunit 1 of the type I interferon receptor, thereby antagonizing all activities associated with type I interferons (IFN-α, IFN-β, and IFN-ω). Type I interferons are a class of cytokines involved in inflammatory responses. IFN-α promotes the activation and differentiation of various immune cells, including driving the differentiation of autoreactive B lymphocytes into immunoglobulin-secreting plasma cells, promoting dendritic cell maturation, and inducing their expression of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Between 60% and 80% of patients with systemic lupus erythematosus (SLE) exhibit a type I interferon high-expression signature, and type I interferon levels are positively correlated with the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score in SLE patients.

Previously, anifrolumab demonstrated positive outcomes, including a significant reduction in disease activity, in the pivotal Phase 3 TULIP-2 trial. The results showed that the candidate drug significantly improved the BILAG-based Composite Lupus Assessment (BICLA) response rate at 52 weeks (47.8% vs. 31.5%). Furthermore, anifrolumab achieved statistically significant improvements in several secondary endpoints, including a higher proportion of patients reducing their oral corticosteroid (OCS) dosage to ≤10 mg/day (51.5% vs. 30.2%) and a greater reduction in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score at 12 weeks (49% vs. 25%).

BICLA improvement signifies that disease activity has improved in all organs, with no new disease flares. The results of the TULIP-2 trial demonstrated the therapeutic potential of anifrolumab in patients with moderate-to-severe systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a complex chronic autoimmune disease in which the body’s immune system attacks its own tissues. Over the past half-century, only one targeted therapy has received FDA approval for the treatment of SLE, leaving a substantial unmet clinical need.

Congratulations to AstraZeneca on the approval of anifrolumab for clinical trials in China. We hope that this product will progress smoothly in clinical research and bring innovative therapies to patients with systemic lupus erythematosus (SLE) at an early date.

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