Core Insights - The latest research confirms that Nefecon® significantly reduces kidney function deterioration by 50% through its positive effects on the first three hits in the "four-hit" model of IgA nephropathy [1][3][4]. Group 1: Efficacy and Mechanism - Nefecon® has been shown to significantly lower levels of Gd-IgA1, IgG anti-IgA antibodies, and IgA immune complexes (IgA-IC), indicating its effectiveness across multiple pathogenic pathways [1][3][4]. - Changes in Gd-IgA1 or polymeric IgA within the first two months of treatment are significantly correlated with reductions in proteinuria, suggesting these biomarkers could guide Nefecon® therapy [1][3][7]. - The NefIgArd trial involved 216 participants and demonstrated that Nefecon® effectively targets the gut to modulate immune responses, thereby reducing pathogenic IgA levels [4][5]. Group 2: Clinical Significance - Nefecon® is the first and only drug approved for the causal treatment of IgA nephropathy in China, the U.S., and Europe, and is recommended in multiple clinical guidelines, solidifying its position as a cornerstone therapy [2][4]. - The drug's ability to intervene at the source of IgA nephropathy's pathogenesis is expected to reshape treatment strategies and provide more options for a broader patient population [4]. Group 3: Patient Impact - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new cases diagnosed annually, highlighting the significant healthcare burden and the need for effective treatments like Nefecon® [3].

Core Insights - The studies presented at the 62nd European Renal Association (ERA 2025) conference confirm the efficacy of Nefeccon (Budesonide delayed-release capsules) in protecting kidney function across various baseline eGFR levels and different pathological changes in patients with IgA nephropathy [2][3][5] Study Findings - The NefIgArd study sub-analysis demonstrated that Nefeccon significantly reduces baseline urine protein-to-creatinine ratio (UPCR) regardless of the baseline eGFR level, showing protective effects on eGFR at all time points [3][6] - A second multicenter study focused on the treatment benefits for IgA nephropathy patients with different pathological manifestations, revealing that after 9 months of Nefeccon treatment, patients exhibited significant reductions in urine protein and stable eGFR, particularly in those with endothelial cell proliferation (E1) and/or crescent formation (C1) [4][10] Clinical Implications - Nefeccon is the first and only IgA nephropathy treatment approved in China, the US, and Europe that is not limited by proteinuria levels, supporting a "treat all" strategy for kidney protection in IgA nephropathy patients [2][5] - The findings provide strong evidence for early initiation of cause-targeted therapy upon diagnosis to protect kidney function and improve overall prognosis for all patients [3][10] Market Context - The prevalence of IgA nephropathy is significantly higher in Asia, with an estimated 5 million patients in China and over 100,000 new cases diagnosed annually, indicating a substantial unmet clinical need [4][5]