NEFECON(R) and EVER001 Drive Synergistic Progress as Everest Medicines Advances

HONG KONG, Jun 12, 2025 - ( JCN Newswire ) - At the 62nd Congress of the European Renal Association (ERA 2025), Everest Medicines presented new results findings on both NEFECON (budesonide delayed release capsules), the world's first and only approved therapy that directly targets the underlying cause of IgA nephropathy (IgAN), and EVER001, a next-generation covalent reversible BTK inhibitor. The latest results provide robust evidence for NEFECON's efficacy across the full disease spectrum and reinforce its foundational role in the emerging IgAN treatment strategy: "Treat the Cause, Treat Early, Treat All". The nine studies covered biomarker-based prediction, treatment outcomes across various diagnostic timelines and baseline kidney function levels, long-term treatment durability, and mechanistic insights.

Two studies further validated the critical role of NEFECON in targeting the underlying mechanisms of IgA nephropathy (IgAN), reinforcing its position as the first-line etiological treatment for the disease. One study, based on the "Four-Hit" hypothesis, demonstrated that NEFECON significantly impacts the first three pathogenic steps, ultimately reducing the risk of kidney function deterioration by 50%. Another study found that reductions in pathogenic Gd-IgA1 and polymeric IgA levels during the first two months of treatment closely correlated with improvements in proteinuria, suggesting their potential as predictive biomarkers to guide treatment.

Two additional studies confirmed the clinical benefits of "Treat Early" with NEFECON. A subanalysis of the NefIgArd study showed that patients who began treatment within six months of diagnosis experienced greater kidney protection and more significant reductions in proteinuria compared to those diagnosed earlier. This highlights the importance of early intervention to slow disease progression and achieve better long-term outcomes. Another prospective study supported this finding, showing that earlier treatment may more effectively reduce pathogenic immune factors and control inflammation, potentially preventing disease relapse or irreversible progression.

Finally, two studies provided strong clinical evidence supporting NEFECON's "Treat All" strategy by confirming its broad applicability across different patient types. A subanalysis of the NefIgArd study found that NEFECON effectively reduced proteinuria and preserved kidney function across all baseline eGFR levels. A separate multicenter study showed that patients with active pathological changes, such as endocapillary hypercellularity or crescent formation, experienced even more pronounced improvements in proteinuria and delayed disease progression.

NEFECON is the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe. It has been included in the KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft). With updated data presented at ERA 2025, NEFECON further solidified its position as a first-line cornerstone therapy, demonstrating a clear mechanism of action, sustained long-term benefits, and suitability for a wide range of patients. As NEFECON continues to gain approvals across global markets, expand reimbursement coverage in China, and advance in tandem with diagnostic tools such as the Gd-IgA1 diagnostic kit under development, Everest Medicines is building a comprehensive diagnosis-treatment-monitoring ecosystem. This integrated approach is designed to shift IgAN management from symptomatic support toward precise, long-term disease control.

In parallel, Everest Medicines' proprietary next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, EVER001, was featured in a focused oral presentation at the 62nd Congress of the European Renal Association (ERA 2025). EVER001 has best-in-class potential for the treatment of primary membranous nephropathy (pMN) and other autoimmune kidney diseases such as IgAN, MCD, FSGS, and LN, targeting a global patient population of over 10 million. As no drug is currently approved for pMN, EVER001 offers a promising new option. Preliminary results from the ongoing Phase 1b/2a trial show that EVER001 is well tolerated and demonstrates strong clinical and immunological responses, including reductions in proteinuria and anti-PLA2R autoantibodies. The study also includes long-term follow-up data, supporting its potential in chronic disease management. Everest Medicines is continuing to expand clinical research to gather more data across patient groups and longer treatment durations.

This advancement complements NEFECON and exemplifies Everest Medicines' "dual-engine" strategy, which combines in-licensed and internally developed innovations to broaden its kidney disease pipeline. Together, NEFECON and EVER001 empower Everest Medicines to build a precise and durable kidney disease management ecosystem, accelerating global expansion and providing patients with accessible, effective treatment options.