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 - A significant observational study confirms that NEFECON (budenoside enteric-coated capsules) provides substantial clinical benefits in the "etiological treatment" of IgA nephropathy, supporting a new management strategy focused on early and long-term treatment [1][4] Group 1: Study Findings - After 12 months of treatment, the NEFECON group showed a reduction in 24-hour urinary protein from 1016 mg to 114 mg, significantly lower than the control group's 291 mg [3] - The estimated glomerular filtration rate (eGFR) slope in the NEFECON group was significantly better than the control group, at 5.4 ml/min/1.73m²/year compared to -3.4 ml/min/1.73m²/year [3] - No severe infections occurred in the NEFECON group, indicating a better safety profile compared to traditional treatments [3] Group 2: Clinical Implications - The 2025 version of the "Clinical Practice Guidelines for Adult IgA Nephropathy" emphasizes the importance of long-term treatment strategies, including immunotherapy, to maintain kidney function and reduce the risk of renal failure [4] - NEFECON is the only approved drug for the etiological treatment of IgA nephropathy, recommended by both domestic and international guidelines for its ability to intervene at the disease's source [4][5] - The latest real-world study results presented at IIgANN 2025 reinforce NEFECON's position as a cornerstone treatment for IgA nephropathy, demonstrating sustained patient benefits after extending treatment beyond the initial 9 months [4][5] Group 3: Market Context - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, highlighting a significant unmet clinical need [5] - NEFECON is the first and only drug for IgA nephropathy to receive full approval in China, the US, and Europe, not limited by urinary protein levels, thus reshaping treatment pathways for this condition [5]

Core Insights - The presentation at the IIgANN2025 highlighted the significant clinical benefits of NEFECON (budesonide delayed-release capsules) for the long-term treatment of IgA nephropathy, supported by real-world data from top hospitals in China [1][2][3] Group 1: Treatment Efficacy - A retrospective study demonstrated that after 12 months of treatment with budesonide, patients showed a significant reduction in 24-hour urinary protein from 1016 mg to 114 mg, compared to 291 mg in the control group [2][3] - The estimated glomerular filtration rate (eGFR) slope for the budesonide group was significantly better at 5.4 ml/min/1.73m²/year versus -3.4 ml/min/1.73m²/year in the control group, indicating better kidney function preservation [2][3] - The study confirmed that budesonide treatment had a favorable safety profile, with no serious infections reported [2][3] Group 2: Clinical Guidelines and Recommendations - The 2025 version of the clinical practice guidelines for IgA nephropathy emphasizes the importance of controlling proteinuria in the short term and maintaining kidney function in the long term, highlighting the role of immunotherapy [3] - Budesonide is the only approved disease-modifying treatment for IgA nephropathy, recommended by both domestic and international guidelines for its mechanism of action in reducing pathogenic IgA production [3][4] Group 3: Market and Patient Demographics - 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 disease-modifying treatment for IgA nephropathy approved in China, the US, and Europe, not limited by proteinuria levels, thus reshaping treatment pathways for patients [4]

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]