AstraZeneca (AZ) has filed for Chinese approval of first-in-class interferon receptor antibody Saphnelo (anifrolumab) for systemic lupus erythematosus (SLE), following its 2021 US registration. The fully human monoclonal antibody (mAb) blocks type I interferon receptor 1 (IFNAR1) signalling implicated in SLE pathogenesis, demonstrating organ-specific disease activity reduction and corticosteroid-sparing effects in Phase III TULIP trials.

Saphnelo would become China's first approved IFNAR1-targeted therapy if authorised, joining two domestic candidates from Genrix Bio and Qyuns Therapeutics in clinical development. The submission expands treatment options for China's estimated 1 million SLE patients, particularly those with refractory skin and joint manifestations inadequately controlled by standard therapies.

According to PharmCube's NextBiopharm® database, Saphnelo has experienced double-digit growth rates since its launch. Click here to request a free trial for NextBiopharm®.