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云顶新耀耐赋康被纳入2025 KDIGO指南,成唯一推荐的IgA肾病一线对因治疗药物

Core Insights - The core product of the company, NEFECON® (Budesonide Delayed-Release Capsules), has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended drug for the etiology-based treatment of IgA nephropathy [2][5] - This inclusion solidifies NEFECON®'s position as a cornerstone treatment for IgA nephropathy, with projected sales reaching 1.2 to 1.4 billion yuan in 2025 and potentially increasing to 2.4 to 2.6 billion yuan in 2026, with long-term forecasts suggesting sales could exceed 5 billion yuan [2][5] Industry Impact - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "etiology-based treatment," establishing NEFECON® as a first-line therapy [3][4] - The guidelines recommend a 9-month treatment course with NEFECON® for all IgA nephropathy patients at risk of renal function decline, with considerations for extending treatment duration to maintain long-term clinical benefits [3][4] - The guidelines also optimize diagnostic and treatment timing, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment early, which is expected to expand the patient population for treatment [3][4] Treatment Strategy - The treatment goals focus on controlling the rate of renal function decline to physiological levels and reducing proteinuria in IgA nephropathy patients [4] - The guidelines emphasize a comprehensive approach to treatment, addressing both immune-driven renal unit loss and the progression to chronic kidney disease (CKD), advocating for early, precise, and long-term management strategies [4][5] - NEFECON® targets intestinal mucosal immune B cells to reduce pathogenic IgA and IgA immune complex formation, thereby mitigating renal immune damage, aligning with the new treatment strategies outlined in the guidelines [5][6] Market Potential - In China, there are approximately 5 million IgA nephropathy patients, with over 120,000 new cases diagnosed annually, indicating a significant market opportunity for NEFECON® [6] - The inclusion of NEFECON® in the KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, alleviating disease burden and improving treatment outcomes for patients [6]