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, becoming the only recommended drug for the etiology-based treatment of IgA nephropathy [2][5] - This inclusion solidifies NEFECON®'s position as a cornerstone treatment for IgA nephropathy, with projected sales reaching 1.2 to 1.4 billion yuan in 2025 and potentially increasing to 2.4 to 2.6 billion yuan in 2026, with long-term forecasts suggesting sales could exceed 5 billion yuan [2][5] Industry Impact - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "etiology-based treatment," establishing NEFECON® as a first-line therapy [3][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 long-term clinical benefits [3][4] - The guidelines also optimize diagnostic and treatment timing, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment early, which is expected to expand the patient population for treatment [3][4] Treatment Strategy - The treatment goals focus on controlling the rate of renal function decline to physiological levels and reducing proteinuria in IgA nephropathy patients [4] - The guidelines emphasize a comprehensive approach to treatment, addressing both immune-driven renal unit loss and the progression to chronic kidney disease (CKD), advocating for early, precise, and long-term management strategies [4][5] - NEFECON® targets intestinal mucosal immune B cells to reduce pathogenic IgA and IgA immune complex formation, thereby mitigating renal immune damage, aligning with the new treatment strategies outlined in the guidelines [5][6] Market Potential - In China, there are approximately 5 million IgA nephropathy patients, with over 120,000 new cases diagnosed annually, indicating a significant market opportunity for NEFECON® [6] - The inclusion of NEFECON® in the KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, alleviating disease burden and improving treatment outcomes for patients [6]

Core Insights - CloudTop New Drug's NEFECON has been included in the 2025 KDIGO guidelines as the only recommended first-line treatment for IgA nephropathy, solidifying its foundational status in the treatment landscape [1][5][6] - The inclusion in the KDIGO guidelines is expected to accelerate the shift from "supportive treatment" to "causal treatment" for IgA nephropathy globally, providing a strong impetus for the clinical adoption of NEFECON [2][6] Company Summary - NEFECON's unique mechanism of action, targeting pathogenic IgA and IgA immune complexes, aligns with the new treatment strategies outlined in the KDIGO guidelines, which emphasize early intervention and immunological management [5][6] - The drug is projected to achieve sales of 1.2 to 1.4 billion yuan in 2025, increasing to 2.4 to 2.6 billion yuan in 2026, with long-term potential to reach 5 billion yuan [1][2] Industry Summary - The 2025 KDIGO guidelines represent a significant shift in the treatment paradigm for IgA nephropathy, focusing on early diagnosis and treatment, which will likely expand the patient population eligible for treatment [3][4] - The guidelines recommend a 9-month treatment course with NEFECON for patients at risk of renal function decline, with considerations for extending treatment duration to maintain long-term clinical benefits [3][4] - The emphasis on a multi-drug approach and the management of immune-driven renal unit loss indicates a move towards more comprehensive treatment strategies for IgA nephropathy [4][6]

Core Insights - The core product of the company, NEFECON (Budesonide Delayed-Release Capsules), has been included in the 2025 KDIGO guidelines as the only recommended drug for the etiology-based treatment of IgA nephropathy, solidifying its foundational status in this area [1][4]. Industry Impact - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "etiology-based treatment," establishing NEFECON as a first-line therapy [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 [2][3]. - The guidelines also optimize diagnostic and treatment timing, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment early, which is expected to expand the patient population significantly [2][3]. Market Potential - NEFECON is projected to achieve annual sales of 1.2 to 1.4 billion yuan in 2025, increasing to 2.4 to 2.6 billion yuan in 2026, with long-term potential to exceed 5 billion yuan [1]. - The inclusion of NEFECON in the KDIGO guidelines is anticipated to accelerate the global shift towards etiology-based treatment for IgA nephropathy, providing a strong impetus for clinical adoption [4][5]. Clinical Validation - NEFECON's mechanism aligns with the guidelines' strategy to prevent the formation of pathogenic IgA and IgA immune complexes, which is crucial for reducing renal damage [4]. - Clinical trials and real-world data have demonstrated NEFECON's efficacy in significantly lowering proteinuria levels and delaying renal function decline, particularly in the Chinese patient population, where it can extend the time to dialysis or kidney transplantation by up to 12.8 years [4][5]. Strategic Positioning - The recognition of NEFECON by global kidney disease authorities not only validates the company's innovative research capabilities in the nephrology field but also lays a solid foundation for future commercialization efforts [1][5].

Core Viewpoint - The company, 云顶新耀, announced that its drug, NEFECON®, has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, establishing it as the only recommended first-line treatment for IgA nephropathy patients at risk of progressive kidney function decline [1] Group 1 - NEFECON® is recommended for a 9-month treatment course for all IgA nephropathy patients with a risk of progressive kidney function decline [1] - The guidelines emphasize that a single 9-month treatment may not be sufficient for long-term benefits in reducing proteinuria and stabilizing estimated glomerular filtration rate (eGFR), indicating the need for extended treatment duration [1]

Core Insights - The article highlights the presentation of real-world research data on NEFECON® (Budesonide Delayed-Release Capsules) at the 18th International IgA Nephropathy Symposium (IIgANN 2025) [1] - A significant observational study demonstrated the efficacy and safety of NEFECON® in treating IgA nephropathy over a 12-month period, confirming its substantial clinical benefits for long-term treatment [1] Company Insights - NEFECON® is showcased as a promising treatment option for IgA nephropathy, with data from multiple top hospitals in China [1] - The research emphasizes the importance of real-world evidence in supporting the clinical use of NEFECON® [1] Industry Insights - The presentation at the symposium indicates a growing interest in innovative treatments for IgA nephropathy within the nephrology field [1] - The findings may influence future treatment guidelines and patient management strategies for IgA nephropathy [1]

Core Insights - The article highlights the presentation of real-world research data by Nephron (NEFECON) at the 18th International IgA Nephropathy Symposium (IIgANN 2025) [1] - A significant observational study demonstrated the efficacy and safety of NEFECON in treating IgA nephropathy over a 12-month period, confirming its substantial clinical benefits for long-term treatment [1] Group 1 - NEFECON showcased seven real-world research studies from top hospitals in China [1] - The observational study specifically evaluated the effectiveness and safety of NEFECON in IgA nephropathy treatment [1] - Results indicated significant clinical benefits of NEFECON for long-term treatment of IgA nephropathy [1]

Core Insights - The presentation of NEFECON at the IIgANN 2025 conference highlights its effectiveness and safety in treating IgA nephropathy, particularly after a 9-month treatment followed by a 12-month continuation, providing valuable evidence for long-term management of the disease [1][3] Group 1: Treatment Efficacy and Safety - NEFECON demonstrated significant efficacy in reducing 24-hour urinary protein levels from 1016 mg to 114 mg after 12 months, compared to 291 mg in the control group [3] - The treatment group showed a better change rate in eGFR compared to the control group, with no severe infections reported and only minor side effects observed, indicating good tolerability [3] Group 2: Clinical Need and Market Potential - There are over 5 million IgA nephropathy patients in China, with an annual increase of 100,000 new cases, indicating a pressing clinical need for effective treatments [1][5] - NEFECON's early market entry has allowed it to accumulate substantial real-world evidence, enhancing its competitive edge in terms of efficacy, safety, and accessibility [5] Group 3: Long-term Treatment Strategy - The latest research supports the strategy of "long-term targeted treatment" for IgA nephropathy, emphasizing the importance of maintaining kidney function while controlling proteinuria [3][4] - NEFECON is the first drug approved for IgA nephropathy treatment globally, with full approvals from multiple regulatory bodies, further solidifying its position in the market [3][5] Group 4: Commercial Performance - Following its inclusion in the national medical insurance directory, NEFECON's accessibility has significantly improved, with a monthly shipment volume exceeding 130,000 bottles and sales revenue reaching 520 million yuan in August 2025 [5] - Forecasts suggest that NEFECON's annual sales could exceed 1.2 to 1.4 billion yuan in 2025 and rise to 2.4 to 2.6 billion yuan in 2026, positioning it as a key drug in the field [5]

Core Insights - The 18th International Symposium on IgA Nephropathy (IIgANN2025) showcased real-world research data on NEFECON, a drug by the company, demonstrating its effectiveness and safety for IgA nephropathy patients after a 12-month treatment period [1][3] Group 1: Treatment Efficacy and Safety - NEFECON showed significant improvement in key efficacy indicators, with 24-hour urinary protein levels decreasing from 1016 mg to 114 mg after 12 months, compared to 291 mg in the control group [3] - The treatment group exhibited better eGFR change rates and no severe infections, indicating good tolerability and safety compared to traditional therapies [3] Group 2: Market Potential and Demand - There are over 5 million IgA nephropathy patients in China, with 100,000 new diagnoses annually, highlighting a pressing clinical need [1][5] - NEFECON's early market entry has allowed it to accumulate substantial real-world evidence, enhancing its effectiveness, safety, and accessibility compared to recently approved competitors [5] Group 3: Long-term Treatment Strategy - The latest research supports the long-term treatment strategy for IgA nephropathy, emphasizing the need for ongoing therapy after initial treatment to maintain kidney function [3][4] - NEFECON is the first drug approved for IgA nephropathy with a focus on long-term causal treatment, aligning with new clinical guidelines [3][4] Group 4: Commercial Performance - Following its inclusion in the national medical insurance directory, NEFECON's accessibility has significantly improved, with a monthly shipment volume exceeding 130,000 bottles and sales revenue reaching 520 million yuan in August 2025 [4][5] - Projected annual sales for NEFECON are expected to exceed 1.2 to 1.4 billion yuan in 2025 and rise to 2.4 to 2.6 billion yuan in 2026, indicating its potential as a blockbuster drug in the field [5]

Core Insights - The latest real-world study data on NEFECON® (Budesonide delayed-release capsules) presented at the 2025 IIgANN conference demonstrates significant clinical benefits for IgA nephropathy patients through long-term targeted therapy [1][3][4] Group 1: Study Findings - A retrospective study evaluated the efficacy and safety of 12 months of Budesonide treatment in IgA nephropathy patients, showing a reduction in 24-hour urinary protein from 1016 mg to 114 mg, significantly lower than the control group [2][3] - The eGFR slope in the Budesonide group was significantly better than the control group, with rates of 5.4 ml/min/1.73m²/year versus -3.4 ml/min/1.73m²/year [2][3] - No serious infections occurred in the Budesonide group, indicating a favorable safety profile compared to traditional treatments [2][3] Group 2: Clinical Implications - The treatment of IgA nephropathy should focus on short-term proteinuria control and long-term kidney function stability, as emphasized in the 2025 guidelines [3] - Budesonide is the only approved targeted therapy for IgA nephropathy, recommended by both domestic and international guidelines for its mechanism of reducing pathogenic IgA production [3][4] - The study reinforces Budesonide's role as a cornerstone treatment for IgA nephropathy, highlighting the necessity of long-term targeted therapy in disease management [3][4] Group 3: Market Context - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, indicating a significant unmet clinical need [4] - NEFECON® is the first and only targeted therapy for IgA nephropathy approved in China, the US, and Europe, not limited by proteinuria levels, thus reshaping treatment pathways for patients [4]

Core Viewpoint - CloudTop New Horizon announced that it will present seven new real-world data studies at the 18th International Symposium on IgA Nephropathy from September 17 to 20, highlighting the clinical value of its treatment in IgA nephropathy [1] Group 1: Clinical Efficacy - The research results demonstrate significant clinical value in "etiological treatment, early intervention, and long-term treatment" [1] - Real-world medication confirms the value of etiological treatment [1] - Early intervention is proven to be important for reducing proteinuria and stabilizing kidney function [1] Group 2: Long-term Data - Over nine months of extended treatment data provides strong evidence for long-term efficacy and safety [1] - The evidence addresses the limitations of randomized controlled trials (RCTs) in clinical application scenarios [1] - The findings enrich treatment strategies for IgA nephropathy [1]