针对耐赋康®9个月以上延长治疗的疗效与安全性尚不明确的问题，澳门镜湖医院开展了一项回顾性真 实世界研究。该研究纳入12例接受耐赋康®16mg/d持续治疗12个月的IgA肾病患者，并匹配36例接受传 统治疗的对照组患者，两组基线年龄、性别、Scr、eGFR、蛋白尿水平等特征均衡可比。 近日，在第23届亚太肾脏病学大会（APCN 2025）上，云顶新耀核心产品耐赋康®（布地奈德肠溶胶囊， NEFECON®）展示了11项来自中国多家顶尖医院的最新临床研究数据，为IgA肾病治疗提供了更多循证医学支 持。 IgA肾病是亚洲高发的慢性肾脏疾病，中国约有500万患者，每年新增确诊超12万人。该疾病具有"高发 病率、高进展率"特点，临床精准治疗需求迫切。在全球首个对因治疗药物耐赋康®在我国被纳入医保 后，随着使用治疗时间的积累，临床医生也逐步将目光从"蛋白尿的改善"移向"肾功能的保护"，以期为 IgA肾病患者的长期管理提供重要参考。 本次大会展示的多项研究，从不同临床场景和长期治疗角度，进一步丰富了耐赋康®的疗效与安全性证 据，巩固了其在IgA肾病一线治疗中的基石地位，为临床应用提供了重要参考。 多场景验证对因治疗价值 临床 ...

Core Insights - The article highlights the significant clinical research data presented at the 23rd Asia Pacific Nephrology Congress (APCN2025) regarding the core product of the company, NEFECON, which provides evidence-based support for the treatment of IgA nephropathy [1][2][3] Group 1: Clinical Research Findings - NEFECON has been demonstrated to have a foundational role in the first-line treatment of IgA nephropathy, with approximately 5 million patients in China and over 120,000 new diagnoses each year [1] - Research from Xi'an Jiaotong University First Affiliated Hospital confirms the importance of a full course of targeted therapy for kidney function protection, suggesting a dual approach of "targeted therapy + supportive treatment" for better disease control [1][2] - A study from Xinjiang Medical University First Affiliated Hospital shows that NEFECON combined with non-steroidal agents can improve eGFR and reduce proteinuria in patients intolerant to systemic glucocorticoids, with no reported serious adverse events during the treatment period [2][3] Group 2: Long-term Treatment Benefits - A retrospective real-world study from Macau Kiang Wu Hospital involving 12 patients treated with NEFECON for 12 months shows significant advantages in proteinuria control and kidney function protection compared to a control group [3] - The NEFECON group saw proteinuria levels decrease from 1016 mg/d to 114 mg/d, while the control group experienced a decrease from 1074 mg/d to 291 mg/d, indicating a significantly greater reduction in the NEFECON group [3] - The annual change in eGFR for the NEFECON group was +5.4 ml/min/1.73m²/year, while the control group showed a decline of -3.4 ml/min/1.73m²/year, demonstrating superior kidney function stability [3] Group 3: Commercial Performance - NEFECON has been included in both the 2025 KDIGO Clinical Practice Guidelines and the 2025 Chinese Adult IgA Nephropathy Clinical Practice Guidelines, making it the only IgA nephropathy targeted therapy recognized by both international and domestic guidelines [4] - Since the implementation of the insurance payment policy on January 1, 2025, NEFECON's sales revenue reached nearly 1 billion yuan from January to September 2025, prompting the company to raise its annual sales guidance to 1.2 billion to 1.4 billion yuan [4] - Multiple brokerages predict that NEFECON's sales could reach 2.4 billion to 2.6 billion yuan by 2026, with peak sales potentially reaching 5 billion yuan [4]

Core Viewpoint - Qilu Pharmaceutical has submitted a listing application for the generic drug Budesonide enteric-coated capsules, which has been accepted by the CDE, marking a significant step in the competitive landscape for this medication in China [1][12]. Company Summary - Qilu Pharmaceutical is actively pursuing the development of Budesonide enteric-coated capsules, which is the first generic version of this drug in the domestic market [1][7]. - The company has over 35 products currently under review, with more than 20 of these submitted this year, indicating a robust pipeline and commitment to expanding its product offerings [10][12]. - If approved, Budesonide enteric-coated capsules will be the first generic version in China, potentially positioning Qilu as a leader in this therapeutic area [12]. Industry Summary - Budesonide is a glucocorticoid with anti-inflammatory properties, and its inhalation formulations have seen significant sales, with over 5.3 billion yuan in sales expected in 2024, reflecting a year-on-year growth of 31.94% [4][6]. - The market for Budesonide enteric-coated capsules is anticipated to grow, especially with the recent approval of this formulation for IgA nephropathy, making it the only drug approved for this indication in China [4][12]. - Currently, only the original drug is available in the market, creating a competitive environment as multiple companies, including Qilu, Hainan Huirui Pharmaceutical, and Shijiazhuang Yiling Pharmaceutical, have submitted applications for the same generic product [7][10].

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]