Seven new real-world evidence studies demonstrating the efficacy and safety of NEFECON® (budesonide enteric capsules) in treating IgA nephropathy (IgAN) will be presented at the 18th International IgA Nephropathy Symposium in Prague, Czech Republic, from September 17-20, 2025. The studies, conducted at leading hospitals across China, provide comprehensive evidence supporting NEFECON's clinical value across three key dimensions consistent with the disease management strategy of "Treat the cause, Treat early, Treat long-term."
Extended Treatment Shows Sustained Benefits
The most significant finding comes from a 12-month extended therapy study led by Chiwa Aoieong and Xiu Yang from Kiang Wu Hospital in Macao and Hangzhou First People's Hospital. The research demonstrated that twelve-month NEFECON therapy significantly reduced proteinuria and preserved renal function in IgAN patients, with a superior safety profile compared to conventional treatment involving systemic corticosteroids and immunosuppressants.
A separate 6-month retrospective cohort study by Shasha Chen and Guisen Li from Sichuan Provincial People's Hospital concluded that NEFECON significantly reduces proteinuria and improves renal function in IgAN patients, with a favorable safety profile supporting its potential as a first-line therapeutic option.
Breakthrough in Pediatric Treatment
For the first time, real-world evidence of NEFECON's efficacy in pediatric patients has been documented. Yu Zhang and Jianhua Zhou from Tongji Hospital evaluated NEFECON in pediatric patients with IgAN or IgA vasculitis nephritis, finding significant impact on reducing proteinuria and hematuria. However, the researchers noted that potential inhibition of the hypothalamic-pituitary-adrenal axis remains a concern requiring careful consideration by pediatric nephrologists.
Special Populations and High-Risk Patients
The studies also addressed treatment in challenging patient populations. Research by Chen and Li examined NEFECON use in IgAN patients with hepatitis B virus coinfection, concluding that budesonide enteric capsules combined with intensive supportive therapy effectively improved renal outcomes without triggering viral reactivation.
Ming Fang from The First Affiliated Hospital of Dalian Medical University investigated NEFECON in patients with IgAN and renal insufficiency, demonstrating potential stabilization of kidney function alongside modest proteinuria reduction with favorable tolerability in high-risk populations.
Chinese Population Validation
A real-world observational study by Junjun Zhang and Zhanzheng Zhao from Zhengzhou University analyzed 26 Chinese IgAN patients, demonstrating NEFECON's sustained renoprotective effects, particularly in those with preserved renal function (eGFR ≥35 mL/min/1.73m²), with progressive proteinuria reduction and hematuria resolution.
Early Intervention Benefits
Research by Xiaoyan Xiao from Qilu Hospital of Shandong University focused on early intervention, showing that budesonide enteric-coated capsules significantly reduced proteinuria and stabilized renal function when used in early IgAN treatment, emphasizing the importance of early diagnosis and treatment.
Regulatory and Clinical Recognition
NEFECON is currently the only etiological treatment for IgAN recommended by both domestic and international guidelines, reinforcing its position as the foundational first-line cornerstone treatment for IgAN patients. The drug has been recommended by authoritative treatment guidelines, including the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" and the "Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults."
NEFECON was included in China's National Reimbursement Drug List (NRDL) in November 2024, and the supplemental application for production expansion was officially approved by NMPA in August 2025. The drug has received full approval from major regulatory agencies including the National Medical Products Administration (NMPA) in China, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
Mechanism of Action
NEFECON is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, according to predominant pathogenesis models.
These real-world evidence studies not only address the limitations of randomized controlled trials in clinical practice but also reinforce NEFECON's position as the world's first etiological treatment for IgAN, providing strong scientific evidence to advance both clinical practice and global research.
