Astrazeneca PLC Sponsored ADR (AZN.US) Reslizumab New Indication Proposed for Priority Review

On October 12, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that a new indication for Astrazeneca PLC Sponsored ADR's (AZN.US) reslizumab injection is proposed for priority review, applicable for reducing proteinuria levels in adult patients with primary IgA nephropathy (IgAN). Reslizumab is a blockbuster-level product under Astrazeneca PLC Sponsored ADR, with global sales of US$4.718 billion in 2025 (YOY +20.23%). Reslizumab is a long-acting C5 complement inhibitor that can provide rapid, sustained, and stable complete inhibition of complement C5. When the complement system is abnormally activated, its excessive response causes the body to attack its own healthy cells. Reslizumab works by targeting and inhibiting the activation of terminal complement C5 in the immune system. Previously, reslizumab has been approved and launched in multiple countries and regions worldwide, including Europe, the United States, Japan, and China. In China, the drug has been approved for three indications, including adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG), adult patients with neuromyelitis optica spectrum disorder (NMOSD), and adult and pediatric patients aged 1 month and older with paroxysmal nocturnal hemoglobinuria (PNH). The new indication proposed for priority review this time is IgA nephropathy. In June 2026, Astrazeneca PLC Sponsored ADR announced the results of the Phase III trial I CAN study (ALXN1210-IgAN-320) of reslizumab in the treatment of adult IgA nephropathy. This is a global, Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of reslizumab in adult patients with IgA nephropathy at risk of disease progression. The trial planned to enroll approximately 510 subjects from 28 countries across North America, South America, Europe, Asia, and Australia. The primary endpoints of the I CAN study were: change from baseline in proteinuria based on 24-hour urine protein-to-creatinine ratio (UPCR) (assessed at Week 34, at the interim analysis), and change from baseline in estimated glomerular filtration rate (eGFR) (assessed at Week 106, at the final analysis). Interim analysis results showed that for the primary endpointchange from baseline in proteinuria based on 24-hour UPCRcompared with the placebo group, patients in the reslizumab group experienced a significant and clinically meaningful reduction in proteinuria levels from baseline. The safety observed in this trial was consistent with the known safety profile of reslizumab, with overall good tolerability and no new safety issues identified. The most common adverse events (AEs) in the reslizumab treatment group were upper respiratory tract infection, nasopharyngitis, and infusion-related reactions; the most common adverse events in the placebo group were upper respiratory tract infection, nasopharyngitis, and hypertension. Dr. Jonathan Barratt, an investigator in the I CAN trial, stated: "For patients with IgA nephropathy, terminal complement activation is a key driver of inflammation and progressive loss of kidney function, which often leads to end-stage renal disease. These interim results indicate that reslizumab, by targeting the terminal complement pathway, can rapidly and significantly reduce proteinuria, supporting its potential as a disease-modifying therapy for this rare and highly harmful disease."