Core Insights - The approval of the expanded production application for the drug Neficon (Budesonide Enteric-Coated Capsules) marks a significant milestone as it is the first and only fully approved treatment for IgA nephropathy in China, the US, and Europe [1][2] - The drug is positioned as a cornerstone therapy for IgA nephropathy, addressing the growing clinical demand in China and Asia, where the disease prevalence is notably high [1] - The drug's unique mechanism of action and clinical advantages have led to its inclusion in both international and domestic clinical guidelines, solidifying its status as a first-line treatment [2] Company Developments - The National Medical Products Administration (NMPA) approved Neficon in November 2023 for adult patients with progressive primary IgA nephropathy, filling a treatment gap in China [2] - Neficon was included in the national medical insurance drug list in November 2024, and received full approval in May 2025, removing restrictions on proteinuria levels for most patients [2] - The CEO of the company emphasized the importance of increasing production capacity to meet the rising clinical treatment needs of IgA nephropathy patients in Asia [1] Industry Context - IgA nephropathy has a high incidence in Asia, with China having one of the highest rates of primary glomerular diseases, estimated to have over 5 million patients and more than 100,000 new cases annually [1] - The drug Neficon has demonstrated significant clinical efficacy, reducing the risk of kidney function decline by 50% in global studies, and by 66% in the Chinese population, delaying disease progression to dialysis or kidney transplantation by an average of 12.8 years [1]

Core Insights - The approval of the expanded production application for the drug Nefikang® (Budesonide Enteric-Coated Capsules) marks a significant milestone as it is the first and only fully approved treatment for IgA nephropathy in China, the US, and Europe [1][2] - The drug addresses a critical unmet medical need in Asia, particularly in China, where the incidence of primary glomerular diseases is the highest globally, with over 5 million patients currently diagnosed with IgA nephropathy [1] - Nefikang® has been recognized in both international and domestic clinical guidelines as the cornerstone treatment for IgA nephropathy, highlighting its innovative mechanism and clinical advantages [2] Company Developments - The CEO of the company emphasized that the increase in production capacity will better meet the growing clinical treatment needs of IgA nephropathy patients in Asia [1] - The drug has been included in the National Medical Insurance Drug List in November 2024, and received full approval from the NMPA in May 2025, removing restrictions on proteinuria levels for most patients [2] - Nefikang® has demonstrated a 50% reduction in the risk of kidney function decline in global Phase III studies, with Chinese population data showing a 66% reduction [1] Industry Context - IgA nephropathy has a high prevalence in Asia, with rapid disease progression and poor prognosis, indicating a significant market opportunity for effective treatments [1] - The approval and subsequent inclusion in treatment guidelines position Nefikang® as a transformative option in the management of IgA nephropathy, shifting the treatment paradigm towards etiology-based therapy [2] - The drug's unique mechanism of action, which targets the underlying causes of IgA nephropathy, sets it apart from traditional supportive treatments [2]

Group 1 - The approval of the expanded production application for the drug Nefikang (Budesonide Enteric-Coated Capsules) marks it as the first and only fully approved treatment for IgA nephropathy in China, enhancing its supply to meet the growing clinical demand in Asia [1] - The CEO of the company emphasized that the increased production capacity will better address the rising clinical treatment needs of IgA nephropathy patients in Asia, particularly in China, which has the highest incidence of primary glomerular diseases globally, with over 5 million patients and more than 100,000 new cases diagnosed annually [1] - Nefikang is currently the only drug recommended by both domestic and international guidelines for the treatment of IgA nephropathy, and its expanded production will accelerate the adoption of targeted treatment, helping more patients initiate standardized treatment early to delay disease progression and protect kidney function [1] Group 2 - Nefikang received formal approval from the NMPA in November 2023 through a priority review process for treating adult patients with primary IgA nephropathy at risk of progression, filling a gap in the domestic treatment landscape [2] - The drug was included in the National Medical Insurance Drug List in November 2024 and received full NMPA approval in May 2025, removing restrictions on proteinuria levels, making it applicable to the majority of IgA nephropathy patients [2] - Nefikang has been incorporated into both the 2024 KDIGO Clinical Practice Guidelines for IgA Nephropathy and the Chinese Clinical Practice Guidelines for Adult IgA Nephropathy, establishing it as a cornerstone treatment for IgA nephropathy [2]

Core Insights - The recent ERA 2025 conference showcased nine new studies on the drug Nefukang® (Budesonide Enteric Capsules), confirming its significant role in reducing pathogenic factors related to IgA nephropathy, particularly in the context of the "four-hit" theory of disease mechanism [1][4] - Nefukang® is the first and only approved drug for targeted treatment of IgA nephropathy in China, the US, and Europe, and has been included in the latest clinical management guidelines, emphasizing early and comprehensive treatment strategies [1][2] Group 1: Clinical Findings - Nefukang® has been shown to significantly lower Gd-IgA1 levels in the blood, impacting the first, second, and third hits of the "four-hit" theory, ultimately reducing kidney function deterioration by 50% [3] - The drug's mechanism involves specific modulation of gut mucosal immunity, which reduces the production of Gd-IgA1, thereby blocking the pathological pathways associated with IgA nephropathy [3][4] Group 2: Patient Impact - In China, over 5 million patients suffer from IgA nephropathy, with more than 100,000 new cases diagnosed annually, highlighting the urgent need for effective treatments [2] - Early treatment with Nefukang® is associated with more significant kidney function protection and disease progression delay, reinforcing the importance of timely intervention in managing IgA nephropathy [5] Group 3: Research Validation - Recent studies indicate that changes in Gd-IgA1 and polymeric IgA levels within the first two months of treatment correlate significantly with reductions in proteinuria, suggesting these markers could guide treatment efficacy [4] - The findings from the ERA 2025 conference provide robust clinical evidence supporting Nefukang® as a leading choice for targeted therapy in IgA nephropathy, potentially transforming treatment paradigms [5]

Core Insights - The recent ERA 2025 conference showcased nine new studies on the drug Nefukang® (Budesonide enteric-coated capsules), confirming its renal protective value for patients with varying baseline eGFR levels and different pathological changes [1][2][3] - Nefukang® is the first and only approved drug for the treatment of IgA nephropathy in China, the US, and Europe, without restrictions based on proteinuria levels, establishing its leadership in first-line treatment [1][4] - The studies support a "total treatment" strategy, emphasizing the importance of early intervention with Nefukang® to protect renal function and improve overall prognosis for all diagnosed patients [1][3] Study Findings - A sub-analysis of the NefIgArd study indicated that treatment with Budesonide enteric-coated capsules for nine months led to reduced proteinuria and stable renal function (eGFR) across all baseline eGFR levels during a two-year study period [2] - Another multi-center study showed significant reductions in proteinuria and stable eGFR in patients with active lesions, particularly those with endothelial cell proliferation and/or crescent formation [2][3] - The findings provide strong evidence for the application of Budesonide enteric-coated capsules in treating IgA nephropathy, offering new treatment options for clinicians [2][3] Clinical Implications - Clinicians are encouraged to initiate cause-specific treatment immediately upon diagnosis to maximize renal function protection and improve patient outcomes [3] - The CEO of Yunding Xinyao highlighted that these studies further validate Nefukang®'s benefits across different renal function levels and pathological types, supporting a new disease management strategy for IgA nephropathy [3] - The prevalence of IgA nephropathy is significantly higher in Asia, with an estimated 5 million patients in China and over 100,000 new cases annually, indicating a substantial unmet clinical need [3] Additional Research - Besides the two key studies, seven other studies presented at the conference covered efficacy prediction markers, treatment sustainability, and safety mechanisms, broadening the applicability of Nefukang® in clinical settings [4] - Nefukang® was included in the national medical insurance drug list as of November 2024, with expectations to leverage its evidence-based advantages to enhance treatment initiation upon diagnosis [4]

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]

Core Viewpoint - NEFECON (Budesonide Delayed-Release Capsules) has been included in the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" in China, marking it as the only IgA nephropathy treatment recommended by both domestic and international guidelines, solidifying its position as a cornerstone therapy for IgA nephropathy patients [1][3]. Group 1: Treatment Guidelines - The guidelines recommend initiating treatment for patients with proteinuria ≥0.5 g/d and suggest kidney biopsy, with treatment goals aimed at reducing proteinuria to <0.5 g/d and maintaining an estimated glomerular filtration rate (eGFR) decline of <1 ml/min annually [2]. - New monitoring for hematuria has been introduced, and interventions targeting immune damage, including reducing pathogenic IgA, are emphasized [2]. - The guidelines advocate for early, cause-targeted, and comprehensive treatment strategies for IgA nephropathy patients, with NEFECON as the preferred treatment option [2][3]. Group 2: Clinical Significance - The inclusion of NEFECON in the guidelines is seen as a significant advancement for clinical practice in China, providing a scientifically backed treatment option for IgA nephropathy patients [3]. - NEFECON is the first and only IgA nephropathy treatment fully approved in China, the US, and Europe, demonstrating significant clinical advantages such as delaying eGFR decline and reducing proteinuria [3][5]. - The NefIgArd Phase III clinical trial showed that NEFECON significantly reduced the risk of kidney function decline by 50% compared to placebo, with a 66% reduction in the Chinese population, potentially delaying the need for dialysis or kidney transplant by 12.8 years [5].

Core Viewpoint - Yunding Xinyao's drug, Naisfukang® (Budesonide enteric-coated capsules), has received full approval from the National Medical Products Administration (NMPA) for treating adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, marking it as the only drug in China approved for this indication [2][4]. Group 1: Drug Approval and Impact - Naisfukang® has transitioned from conditional approval to full approval, allowing it to be used for all IgAN patients at risk of progression, thus broadening its patient base and addressing unmet clinical needs [2][3]. - The drug's approval is based on complete clinical data from the NefIgArd Phase III study, which demonstrated significant renal function protection over two years [4]. Group 2: Clinical Significance and Guidelines - IgA nephropathy is the most common primary glomerulonephritis and a leading cause of renal failure, with Asian populations having a 56% higher risk of progression to end-stage renal disease (ESRD) [3][4]. - The 2024 KDIGO guidelines highlight Naisfukang® as the only treatment proven to reduce IgA and IgA immune complex levels, emphasizing its role in changing treatment standards for IgAN [4]. Group 3: Accessibility and Insurance Coverage - Naisfukang® has been included in the national medical insurance drug list, effective January 1, 2025, enhancing affordability and accessibility for IgAN patients across 26 provinces and cities in China [4].