Core Viewpoint - Clouding New Horizon (01952) saw a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Company Developments - NEFECON demonstrated substantial clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with existing progression risks, highlighting a delay in treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Insights - The new guidelines recommend a 9-month treatment with NEFECON® (budenoside enteric-coated capsules) for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1) [1][2] - NEFECON® has received recommendations from both the global Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and the new Chinese guidelines, making it the only drug for IgA nephropathy with such dual recognition [2][4] - The 2025 Chinese guidelines emphasize a "stratified and staged" comprehensive treatment approach, highlighting the importance of etiology-based, early, and long-term treatment [1][3] Treatment Strategy - The new guidelines outline a two-phase treatment strategy for IgA nephropathy, including induction of remission and maintenance therapy, focusing on controlling the driving factors of progressive IgA nephropathy [2][3] - The guidelines stress the need for further research on pathogenic Gd-IgA1 and other biomarkers to facilitate etiology-based treatment, marking a significant shift from symptomatic to etiological treatment [3] Patient Demographics and Market Need - Approximately 5 million patients in China suffer from IgA nephropathy, with over 120,000 new diagnoses each year, indicating a substantial unmet clinical need [3] - NEFECON® targets intestinal mucosal immune B cells to reduce pathogenic IgA and IgA-IC formation, thereby alleviating immune damage to the kidneys, demonstrating both efficacy and safety [3][5] Regulatory Approvals - NEFECON® is the first drug for IgA nephropathy to receive full approval from multiple regulatory bodies, including the NMPA, FDA, EMA, and MHRA, without baseline proteinuria level restrictions [4][6] Company Overview - Cloudbreak New Horizon is a biopharmaceutical company focused on innovative drug and vaccine development, clinical development, manufacturing, and commercialization, addressing unmet medical needs in the Asian market [7]

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, establishing its position as the only recommended disease-modifying treatment for IgA nephropathy [1][4] - The inclusion in the global guidelines is expected to solidify NEFECON®'s leading position in the market, with projected sales reaching 1.2-1.4 billion CNY in 2025 and potentially increasing to 2.4-2.6 billion CNY in 2026, with long-term forecasts suggesting sales could exceed 5 billion CNY [1][5] Industry Developments - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "disease-modifying treatment," emphasizing the need for early intervention and long-term management [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 to maintain clinical benefits [2][3] - The guidelines also optimize the timing of diagnosis and treatment, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment promptly, which is expected to expand the patient population eligible for treatment [2][3] Mechanism and Efficacy - NEFECON® is recognized for its unique mechanism that targets intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA immune complexes (IgA-IC), thereby alleviating renal immune damage [4][5] - Clinical studies and real-world data have demonstrated that NEFECON® can significantly lower proteinuria levels and delay renal function decline, particularly in the Chinese population, where it can extend the time to dialysis or kidney transplantation by up to 12.8 years [4][5] Market Impact - The recommendation of NEFECON® in the 2025 KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, where there are approximately 5 million patients and over 120,000 new cases diagnosed annually [5] - This shift towards "disease-modifying treatment" is anticipated to provide new hope for IgA nephropathy patients globally and lays a solid foundation for the company's future commercialization strategies [5]

Core Insights - The core product of the innovative drug company, Cloudtop New Medicine Technology Co., Ltd. (云顶新耀), NEFECON® (Budesonide Enteric Capsules), has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended causal treatment for IgA nephropathy in the guidelines [1] Group 1 - IgA nephropathy is characterized by the deposition of Immunoglobulin A (IgA) immune complexes in the glomeruli, leading to kidney inflammation and potential progression to chronic kidney failure. In China, there are approximately 5 million IgA nephropathy patients, with over 120,000 new cases diagnosed each year [1] - The guidelines emphasize "early intervention, precise treatment, and improved prognosis" as core objectives, achieving multidimensional breakthroughs in the entire process of IgA nephropathy diagnosis and treatment, which is considered a milestone for global clinical practice [1] - The guidelines highlight the need to manage specific driving factors of nephron loss and stress the importance of intervening at the source to reduce immune damage to the kidneys [1] Group 2 - The inclusion of NEFECON® in the 2025 KDIGO guidelines not only provides new treatment options for IgA nephropathy patients but also signifies a shift in global treatment strategies. Previously, due to a lack of effective causal treatment, nearly all patients faced the risk of kidney function decline to end-stage renal disease [1] - The new guidelines advocate for early diagnosis and treatment, focusing on immunological interventions to reduce kidney immune damage, thereby changing the treatment pathway and promoting causal treatment as the mainstream approach [1]

Core Viewpoint - CloudTop New Horizon's core product NEFECON® has been included in the 2025 KDIGO guidelines as the only recommended treatment for IgA nephropathy, marking a significant shift in global treatment strategies for this condition [2][2][2] Company Summary - NEFECON® (Budesonide enteric-coated capsules) is recognized as a new treatment option for IgA nephropathy patients, addressing a previously unmet need in the market [2][2] - The inclusion in the KDIGO guidelines signifies a milestone in clinical practice for IgA nephropathy treatment, emphasizing early diagnosis and intervention from an immunological perspective [2][2] Industry Summary - IgA nephropathy is characterized by the deposition of immunoglobulin A (IgA) immune complexes in the glomeruli, leading to inflammation and potential chronic kidney failure, with approximately 5 million patients in China and over 120,000 new cases diagnosed annually [2][2] - The KDIGO guidelines focus on early intervention, precise treatment, and improving prognosis, highlighting the need to manage specific factors driving kidney unit loss and the formation of pathogenic immune complexes [2][2]

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 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 18th International Symposium on IgA Nephropathy (IIgANN) will be held in Prague, Czech Republic from September 17 to 20, 2025, where Nefecon® will present seven new real-world data studies showcasing its advancements in the field [1] - Nefecon® is the first IgA nephropathy treatment drug fully approved by multiple regulatory agencies including NMPA, FDA, EMA, and MHRA, highlighting its global significance [1][2] - Recent data from top hospitals in China demonstrate Nefecon®'s efficacy and safety in treating IgA nephropathy, emphasizing its clinical value in "etiological treatment, early intervention, and long-term treatment" [1][2] Group 1: Clinical Efficacy and Safety - Nefecon® has shown significant clinical value in treating IgA nephropathy, with real-world evidence validating its efficacy in reducing proteinuria and stabilizing kidney function [1][2] - A 12-month study indicated that Nefecon® significantly lowers proteinuria and protects kidney function compared to traditional treatments, with better safety profiles [3] - A 6-month retrospective cohort study confirmed that Nefecon® effectively reduces proteinuria levels and improves kidney function in Chinese patients, supporting its potential as a first-line treatment [4] Group 2: Treatment Guidelines and Recommendations - Nefecon® has been included in the 2024 KDIGO clinical management guidelines for IgA nephropathy and IgA vasculitis, as well as the Chinese adult guidelines, establishing its foundational role in treatment [2] - The drug emphasizes the need for both etiological and supportive treatments, marking a shift in traditional IgA nephropathy treatment approaches [2] Group 3: Special Cases and Observational Studies - Case reports indicate that Nefecon® can effectively treat IgA nephropathy patients co-infected with hepatitis B virus without causing viral reactivation, providing evidence for its use in this specific population [6] - Observational studies show that Nefecon® maintains kidney protection in patients with primary IgA nephropathy and renal insufficiency, demonstrating its potential in high-risk groups [8]

Core Insights - The article highlights the significant clinical value of Nefecon® in the treatment of IgA nephropathy, demonstrating efficacy in "etiological treatment, early intervention, and long-term treatment" [1][2][3] Group 1: Clinical Data and Evidence - Recent real-world data from top hospitals in China show that Nefecon® effectively reduces proteinuria and stabilizes renal function, with over 9 months of extended treatment providing strong evidence for its long-term efficacy and safety [2][4] - Nefecon® is the only drug recommended in both international and domestic guidelines for the etiological treatment of IgA nephropathy, solidifying its position as a cornerstone therapy [3][11] Group 2: Conference Presentation - Nefecon® will present seven new real-world data studies at the 18th International IgA Nephropathy Symposium (IIgANN 2025) in Prague, Czech Republic, from September 17 to 20, 2025 [1][2] Group 3: Regulatory Approvals and Guidelines - Nefecon® has been included in the 2024 KDIGO guidelines and the Chinese adult IgA nephropathy clinical practice guidelines, marking it as a pivotal treatment option [3] - The drug was successfully added to the National Medical Insurance Drug List in November 2024 and received approval for production expansion from the National Medical Products Administration in August 2025 [3] Group 4: Mechanism of Action - Nefecon® is designed to target intestinal mucosal B cells, reducing the production of pathogenic IgA1, which is implicated in the disease's progression [11]

Core Insights - Nefecon® (耐赋康®) will present seven new real-world data studies at the 18th International IgA Nephropathy Symposium (IIgANN 2025), showcasing its efficacy and safety in treating IgA nephropathy [1][2] - The data highlights significant clinical value in "etiological treatment, early intervention, and long-term treatment," reinforcing Nefecon®'s position as a cornerstone therapy for IgA nephropathy [2][3] Group 1: Clinical Efficacy and Safety - Real-world evidence from top hospitals in China demonstrates that Nefecon® significantly reduces proteinuria and stabilizes renal function, particularly with over nine months of extended treatment [2][4] - Nefecon® is the only drug recommended in both international and domestic guidelines for the etiological treatment of IgA nephropathy, establishing its leading role in clinical practice [3][11] Group 2: Regulatory Approvals and Market Position - Nefecon® was successfully included in the National Medical Insurance Drug List in November 2024 and received approval for production expansion from the National Medical Products Administration in August 2025 [3] - It is the first IgA nephropathy treatment drug fully approved by regulatory agencies in multiple regions, including China, the USA, and Europe, enhancing its market presence [3][11] Group 3: Research Studies Presented - A 12-month study indicates that Nefecon® treatment significantly lowers proteinuria and protects renal function compared to traditional therapies [4] - A retrospective cohort study over six months shows that Nefecon® effectively reduces proteinuria and improves renal function in Chinese patients, supporting its potential as a first-line treatment [6] - Case reports demonstrate the efficacy of Nefecon® in patients with concurrent hepatitis B virus infection, providing evidence for its safe use in this population [7]