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, establishing its position as the only recommended disease-modifying treatment for IgA nephropathy [1][4] - The inclusion in the global guidelines is expected to solidify NEFECON®'s leading position in the market, with projected sales reaching 1.2-1.4 billion CNY in 2025 and potentially increasing to 2.4-2.6 billion CNY in 2026, with long-term forecasts suggesting sales could exceed 5 billion CNY [1][5] Industry Developments - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "disease-modifying treatment," emphasizing the need for early intervention and long-term management [2][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 clinical benefits [2][3] - The guidelines also optimize the timing of diagnosis and treatment, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment promptly, which is expected to expand the patient population eligible for treatment [2][3] Mechanism and Efficacy - NEFECON® is recognized for its unique mechanism that targets intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA immune complexes (IgA-IC), thereby alleviating renal immune damage [4][5] - Clinical studies and real-world data have demonstrated that NEFECON® can significantly lower proteinuria levels and delay renal function decline, particularly in the Chinese population, where it can extend the time to dialysis or kidney transplantation by up to 12.8 years [4][5] Market Impact - The recommendation of NEFECON® in the 2025 KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, where there are approximately 5 million patients and over 120,000 new cases diagnosed annually [5] - This shift towards "disease-modifying treatment" is anticipated to provide new hope for IgA nephropathy patients globally and lays a solid foundation for the company's future commercialization strategies [5]
云顶新耀耐赋康®获2025 KDIGO指南推荐，成为唯一推荐的IgA肾病对因治疗药物