On September 18, at the 18th International Symposium on IgA Nephropathy (IIgANN 2025), NEFECON® (budesonide enteric-coated capsules) presented seven latest real-world study data from multiple leading hospitals in China. Among these, a significant observational study evaluated the 12-month efficacy and safety of NEFECON® in treating IgA nephropathy, with results confirming the drug's substantial clinical benefits in "long-term targeted treatment" of IgA nephropathy. These research findings not only provide clear direction for subsequent treatment after the 9-month course for IgA nephropathy patients but also offer valuable evidence-based medical support for long-term treatment of IgA nephropathy patients.

The 18th International Symposium on IgA Nephropathy was held from September 17-20 in Prague, Czech Republic.

IgA nephropathy is a chronic autoimmune glomerular disease with insidious onset. Currently, IgA nephropathy has high prevalence in Asia, with Asian populations showing 56% higher risk of progressing to end-stage renal disease compared to other populations, and faster disease progression. IgA nephropathy is also one of the main causes of kidney failure among young and middle-aged adults in China, with approximately 60% of Chinese patients progressing to end-stage renal disease (ESRD) within 15 years, creating multiple pressures on patients, families, and society. Therefore, delaying disease progression and protecting patients' kidney function through long-term targeted treatment is of crucial importance for IgA nephropathy treatment.

To further explore the value of extended NEFECON® treatment after completing 9 months of therapy, the retrospective study presented at IIgANN 2025 aimed to evaluate the real-world efficacy and safety of 12-month budesonide enteric-coated capsule treatment in IgA nephropathy patients and compare it with conventional treatment.

The study included 12 biopsy-confirmed IgA nephropathy patients who received 12 months of budesonide enteric-coated capsule treatment (16 mg/day), along with 36 propensity score-matched control group patients receiving conventional treatment (mainly corticosteroids combined with immunosuppressants).

Results showed that after 12 months, the budesonide enteric-coated capsule group's 24-hour urine protein decreased from 1016 mg to 114 mg (P=0.037), significantly lower than the control group's 291mg (P=0.01). The budesonide enteric-coated capsule group's eGFR slope was significantly better than the control group (5.4 ml/min/1.73m2/year vs. -3.4 ml/min/1.73m2/year, P=0.032), with no serious infections occurring.

The study demonstrates that 12-month budesonide enteric-coated capsule treatment can significantly reduce proteinuria levels in IgA nephropathy patients and protect kidney function, with superior safety compared to conventional treatment.

Professor Lü Jicheng from Peking University First Hospital stated: "IgA nephropathy is the most common chronic glomerulonephritis worldwide, especially prevalent in Asian populations, with kidney survival rates as low as 40% at 15 years post-diagnosis, representing a heavy disease burden. IgA nephropathy treatment must follow the core objectives of 'short-term proteinuria control, long-term kidney function stabilization.' The 2025 Chinese Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (preliminary version) clearly states that patients need short-term proteinuria control to <0.5 g/d (<0.3 g/d preferred), and after reaching targets, treatment plans including low-dose maintenance or repeated safe immunotherapy should be adopted to ensure eGFR decline <1 ml/min annually, fundamentally reducing kidney failure risk, emphasizing the importance of immunotherapy in long-term IgA nephropathy treatment.

Budesonide enteric-coated capsules, as the currently only approved targeted treatment drug for IgA nephropathy indication, work through intestinal mucosal immune B-cell regulatory effects, reducing pathogenic IgA production and intervening in disease progression from the source, receiving consistent recommendations from authoritative domestic and international guidelines. The Chinese research published at IIgANN 2025 further confirms that 12-month budesonide enteric-coated capsule treatment can reduce patients' 24-hour urine protein from 1016 mg to 114 mg, significantly superior to the conventional treatment group, with eGFR change rates also significantly better than the control group, with no serious infections and only minor side effects in few patients, showing good tolerability. This study clarifies the direction for subsequent treatment after 9 months of therapy for IgA nephropathy patients and establishes the foundation for budesonide enteric-coated capsules' value in long-term disease management."

EVEREST MED (01952) Chief Executive Officer Luo Yongqing stated: "The latest real-world research results for NEFECON® presented at IIgANN 2025 demonstrate that patients can continue to benefit from extended treatment after completing 9 months of NEFECON® therapy, with superior safety compared to conventional treatment regimens, confirming NEFECON®'s clinical value in 'long-term targeted treatment.' These latest real-world studies further consolidate NEFECON®'s cornerstone position as first-line treatment for IgA nephropathy and scientifically demonstrate the clinical value and necessity of 'long-term targeted treatment' as a core disease management strategy.

It is estimated that China has over 5 million IgA nephropathy patients, with over 100,000 newly diagnosed cases annually. Chinese IgA nephropathy patients show rapid disease progression and poor prognosis, representing significant unmet clinical needs. As the world's first and currently only IgA nephropathy targeted treatment drug fully approved in China, the United States, and Europe without proteinuria level restrictions, NEFECON® is continuously reshaping IgA nephropathy treatment pathways, providing more effective treatment options for IgA nephropathy patients and helping improve patients' long-term quality of life."

NEFECON® is currently the world's first IgA nephropathy treatment drug to receive full approval from China's National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and EVEREST MED's other Asian authorized regions (Hong Kong, Macau, Taiwan, Singapore, and South Korea).