NEFECON Real World Evidence 2025: Seven Abstracts at IgAN Symposium

SHANGHAI, Sept. 15, 2025 /PRNewswire/ -- At the 18th International lgA Nephropathy Symposium (IIgANN 2025), 7 new abstracts based on real-world evidence of NEFECON® will be presented. The 18th IIgANN will take place in Prague, Czech Republic, from September 17 to 20, 2025.

The newly released results, based on clinical practices at several leading hospitals in China, offer a comprehensive overview of the efficacy and safety of NEFECON® in the treatment of IgA nephropathy (IgAN). The clinical value of NEFECON® was highlighted across three key dimensions, consistent with the new disease management strategy of "Treat the cause, Treat early, Treat long-term." In real-world clinical practice, there is strong validation of NEFECON®'s value as an etiological treatment, where early intervention is critical in reducing proteinuria and protecting renal function, and extended treatment beyond 9 months provided robust evidence supporting sustained efficacy and safety.

These real-world evidence not only address the limitations of randomized controlled trials (RCTs) in clinical practice but also reinforce the new disease management strategy of "Treat the cause, Treat early, Treat long-term". They further strengthen NEFECON®'s position as the world's first etiological treatment for IgAN, providing strong scientific evidence to advance both clinical practice and global research.

NEFECON® has been recommended by several authoritative treatment guidelines, including the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft)", and the "Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)". NEFECON® was included in China's National Reimbursement Drug List (NRDL) in November 2024, and the supplemental application for the production expansion of NEFECON® has been officially approved by NMPA in August 2025.

NEFECON® is currently the world's first IgAN treatment to have received full approval from the National Medical Products Administration (NMPA) in China, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency（MHRA）in the United Kingdom, as well as in other Asian territories where Everest Medicines holds the rights, including Hong Kong SAR, Macao SAR, Taiwan region (China), Singapore, and South Korea.

Abstracts

1. Abstract Number: P-45
Title: Beyond Nine Months: Real-World Efficacy and Safety of Extended Nefecon Therapy in IgA Nephropathy
Principal author and institution: Chiwa Aoieong, Xiu Yang. Kiang Wu Hospital, Department of Nephrology, Macao, China; Hangzhou First People's Hospital Affiliated to Westlake University School of Medicine, Department of Nephrology, Hangzhou, China
Abstract：The study is to assess the efficacy and safety of 12-month Nefecon therapy in IgAN patients in a real-world setting, compared to conventional treatment. In conclusion, twelve-month Nefecon therapy significantly reduced proteinuria and preserved renal function in IgAN patients, with a better safety profile compared to conventional treatment involving systemic corticosteroids and immunosuppressants.

2. Abstract Number: P-44
Title: Efficacy and Safety of Nefecon in IgA Nephropathy: A 6-Month Retrospective Cohort Study
Principal author and institution: Shasha Chen, Guisen Li, Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital, Department of Nephrology, Chengdu, China.
Abstract: The study is to evaluate the clinical efficacy and safety of Nefecon (budesonide enteric capsules) in patients with IgA nephropathy (IgAN). In conclusion, Nefecon significantly reduces proteinuria and improves renal function in IgAN patients, with a favorable safety profile. These findings support its potential as a first-line therapeutic option for IgAN. Further randomized controlled trials with larger cohorts are warranted to validate these results.

3. Abstract Number: P-43
Title: Budesonide enteric capsules* for IgA nephropathy with hepatitis B virus infection: Two cases
Principal author and institution: Shasha Chen, Guisen Li, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital，Department of Nephrology, Chengdu, China
Abstract: The study is to evaluate the efficacy and safety of budesonide enteric capsules in patients with IgAN and chronic HBV infection. In conclusion, budesonide enteric capsules combined with intensive supportive therapy effectively improved renal outcomes in IgAN patients with HBV coinfection without triggering viral reactivation. This case report provides an evidence-based support for the use of budesonide enteric capsules in the special population, suggesting that targeted intestinal immunity modulate the number and activity of mucosal B cells in ileal Peyer's patches may be a preferred strategy under strict HBV biomarker monitoring.

* Budesonide enteric capsules are Nefecon.

4. Abstract Number: P-63
Title: First real-world evidence of Nefecon efficacy in pediatric patients with IgA nephropathy or IgA vasculitis nephritis
Principal author and institution: Yu Zhang, Jianhua Zhou, Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Abstract: The study is to evaluate the efficacy of Nefecon in pediatric patients with IgAN/IgAVN. In conclusion, in this real-world setting, Nefecon shows a significant impact on reducing proteinuria and hematuria in pediatric patients with IgAN/IgAVN. However, its potential inhibition of the hypothalamic-pituitary-adrenal axis remains a concern that warrants meticulous consideration by pediatric nephrologists.

5. Abstract Number: P-64
Title: Efficacy and Safety Profile of Nefecon in 26 Chinese Patients with IgA Nephropathy: A Real-World Observational Study
Principal author and institution: Junjun Zhang, Zhanzheng Zhao, The Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Abstract: The study is to assess real-world clinical outcomes and safety of Nefecon in Chinese IgAN patients. This real-world analysis demonstrates Nefecon's sustained renoprotective effects in Chinese IgAN patients, particularly those with preserved renal function (eGFR ≥35 mL/min/1.73m²), with progressive proteinuria reduction and hematuria resolution. The favorable safety profile supports its clinical utility in this population.

6. Abstract Number: P-48
Title: Nefecon Treatment in Patients with Primary IgA Nephropathy and Renal Insufficiency: A 6 - Month Observational Study
Principal author and institution: Ming Fang，Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Renal Translational Medicine Center of Liaoning Province, Dalian, China
Abstract: The study is to investigate the effectiveness and safety of Nefecon in patients with IgAN and renal insufficiency. In conclusion, six-month Nefecon therapy demonstrated potential stabilization of kidney function alongside modest proteinuria reduction, with favorable tolerability in high-risk IgAN populations.

7. Abstract Number: P-62
Title: Early Intervention with Budesonide Enteric-Coated Capsules* in IgA Nephropathy: 2 Case Demonstrating Reduced Proteinuria and Stabilized Renal Function
Principal author and institution: Xiaoyan Xiao, Qilu Hospital of Shandong University, Department of Nephrology, Jinan, Shandong, China
Abstract: The study is to evaluate its efficacy and safety in the early treatment of IgAN. In conclusion, budesonide enteric-coated capsules significantly reduced proteinuria and stabilized renal function and well tolerated in the early treatment of IgAN. Early diagnosis and treatment of patients are particularly important in IgAN.

* Budesonide enteric capsules are Nefecon.