Core Insights - The new guidelines recommend a 9-month treatment with Budesonide delayed-release capsules (NEFECON) for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1) [2][3] - NEFECON is the only drug approved for causal treatment of IgA nephropathy that has received recommendations from both international and domestic guidelines [2][4] Industry Overview - The 2025 Chinese guidelines for IgA nephropathy emphasize a "layered and staged" comprehensive treatment approach, highlighting the importance of causal treatment, early intervention, and long-term management [7] - The guidelines focus on pathogenic galactose-deficient IgA1 (Gd-IgA1) as a key factor in disease onset, marking a shift from symptomatic to causal treatment [3][7] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [3] Company Insights - NEFECON has shown efficacy in reducing kidney function decline by 50% globally and can delay kidney function deterioration by up to 66% in the Chinese population, extending the time to dialysis or kidney transplantation by 12.8 years [5] - NEFECON is the first drug for IgA nephropathy to receive full approval from multiple regulatory bodies, including NMPA, FDA, EMA, and others, without baseline proteinuria level restrictions [4] - The drug is designed to target intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA-IC, thereby alleviating immune damage to the kidneys [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 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 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]

Core Insights - The article highlights the significant progress made by the Hong Kong-based innovative pharmaceutical company, YunTing New Medicine, with its drug, Naisufang® (Budesonide Enteric-Coated Capsules), which is the first and only fully approved treatment for IgA nephropathy [1][6] - The drug has received approval for a new indication in Taiwan, allowing it to be used for all adult patients at risk of disease progression, thus expanding its patient base and market potential [1][5] Group 1: Market Potential and Demand - IgA nephropathy is the most common primary glomerular disease globally, with a notably higher prevalence in Asian populations, where the risk of progression to end-stage renal disease is 56% higher compared to other populations [2] - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new diagnoses each year, indicating a substantial market demand for effective treatments [2] - The approval of Naisufang® is expected to generate sales of 1 billion yuan in its first full year post-launch, reflecting its strong market potential [1][6] Group 2: Clinical and Regulatory Advancements - Naisufang® has been recognized as a breakthrough therapy by the Chinese National Medical Products Administration (NMPA), filling a significant gap in the treatment of IgA nephropathy [2][4] - The drug's unique mechanism of action, which targets gut mucosal immunity and reduces the production of pathogenic IgA1, has been validated through clinical studies, demonstrating a 50% reduction in kidney function decline [4] - The drug has received dual recommendations from both domestic and international guidelines, solidifying its position as a first-line treatment for IgA nephropathy [4] Group 3: Supply and Production Capacity - The approval for the expansion of Naisufang® production capacity was granted in August, addressing the urgent need to meet the growing market demand [3] - The expansion will ensure a steady supply of the drug across China and the broader Asian region, alleviating the unmet clinical needs for IgA nephropathy treatments [3] Group 4: Commercialization and Market Strategy - YunTing New Medicine has established an efficient commercialization framework, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [6] - The drug's comprehensive approval across multiple regulatory bodies, including the NMPA, FDA, and EMA, enhances its market accessibility and patient coverage in Asia [6] - Analysts predict that Naisufang® could reach peak sales of 5 billion yuan, indicating its potential as a blockbuster product in the nephrology market [6]

Core Viewpoint - CloudTop New Drug (1952.HK) has received full approval for its core nephrology product, Nefikang, in Taiwan, removing previous conditions and solidifying its position as a first-line treatment for IgA nephropathy in Asia [1][2] Group 1: Product Approval and Market Potential - Nefikang is now fully approved in all authorized regions, enhancing its status as a cornerstone treatment for IgA nephropathy [1] - The product's production capacity upgrade has been approved by the NMPA, allowing for a more efficient response to the growing clinical demand in China and Asia [1][2] - The market potential is significant, with expectations of achieving sales of 1 billion yuan in its first full year post-launch [1] Group 2: Clinical Significance and Treatment Landscape - IgA nephropathy is the most common primary glomerular disease globally, with a higher risk of progression to end-stage renal disease in Asian populations [2] - Nefikang fills a critical gap in the treatment landscape, being the first drug approved for targeted therapy in IgA nephropathy, addressing previous limitations of existing treatments [2][3] - Clinical studies show that Nefikang can reduce kidney function decline by up to 66% in the Chinese population, significantly delaying the need for dialysis or kidney transplantation [3] Group 3: Commercialization and Market Strategy - Nefikang is the first IgA nephropathy treatment to receive full approval from multiple regulatory agencies, including NMPA, FDA, and EMA, establishing a strong foundation for commercialization [4] - The drug has already reached over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients, demonstrating the company's market penetration capabilities [4] - Sales peak forecasts suggest that Nefikang could reach 5 billion yuan, indicating its potential as a major product in the nephrology market [4]

Core Viewpoint - Cloudtop New Horizon Pharmaceutical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the expansion of production for its drug, Nefukang (Budenoside Enteric-Coated Capsules), which is the first and only approved treatment for IgA nephropathy in China, the US, and Europe, aiming to meet the growing clinical demand in China and Asia [2] Company Summary - Nefukang was approved in November 2023 through a priority review process, becoming the first approved drug for the cause of IgA nephropathy in China, filling a significant treatment gap [2] - The projected annual sales for Nefukang in 2024 are expected to reach 354 million yuan [2] - In November 2024, Nefukang will be included in the national medical insurance catalog, and by May 2025, it will receive full approval from NMPA, removing previous restrictions on proteinuria levels, thus expanding the potential patient population by three times [2] - Currently, Nefukang has covered over 80% of potential hospitals in China, benefiting more than 20,000 patients, indicating a strong demand for increased production capacity to meet patient needs [2] Industry Summary - China has the highest incidence rate of primary glomerular diseases globally, highlighting the urgent need for effective treatments like Nefukang [2] - Cloudtop New Horizon is also developing a next-generation covalent reversible BTK inhibitor, EVER001, which aims to address global clinical gaps in diseases such as primary membranous nephropathy (pMN), minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS) [2] - The company is advancing clinical research for a Gd-IgA1 diagnostic reagent, expected to be approved for market by 2026, which may replace kidney biopsy as an auxiliary diagnostic tool [2]