（编辑 张琳卿 张伟） 国际IgA肾病联盟中国协作组主席、北京大学第一医院肾内科主任张宏教授表示："指南以'早期干预、 精准治疗、改善预后'为核心目标，在IgA肾病诊疗全流程中实现了多维度突破，对于全球IgA肾病治疗 的临床实践具有里程碑式的意义。指南提出IgA肾病治疗需同时关注免疫性因素驱动的肾单位丢失，以 及继发于前者的慢性肾脏病病程。其中明确需管理肾单位丢失的特异性驱动因素，强调从源头去干预致 病性免疫复合物的形成，从而减轻肾脏的免疫损伤。" 云顶新耀方面认为，此次耐赋康®被纳入2025 KDIGO指南，不仅为IgA肾病患者提供了新的治疗选择， 也标志着全球治疗策略的转变。"过去，由于缺乏有效的对因治疗，IgA肾病几乎所有患者都面临肾功能 衰退至终末期肾病的风险。而新的指南则强调尽早诊断、尽早治疗，并从免疫学层面进行干预，减少肾 脏免疫损伤，改变了治疗路径，推动'对因治疗'成为主流。"企业相关负责人称。 本报讯 （记者金婉霞）9月19日，港股创新药企云顶新耀医药科技有限公司（以下简称"云顶新耀"）宣 布，其核心产品耐赋康®（布地奈德肠溶胶囊，NEFECON®）被纳入全球肾脏病权威指南 《2025KDIG ...

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]

9月19日，港股创新药企云顶新耀(01952.HK)宣布，其核心产品耐赋康(布地奈德肠溶胶囊，NEFECON) 被纳入全球肾脏病权威指南《2025KDIGO IgA肾病和IgA血管炎临床管理实践指南》，并成为该指南中 唯一推荐的IgA肾病对因治疗药物。这一纳入标志着耐赋康作为IgA肾病对因治疗药物的基石地位得到 确立并强化。 业内人士分析指出，此次指南确认耐赋康为唯一从源头干预致病机制的IgA肾病一线对因治疗药物，其 行业领先地位短期将难以被撼动。依托全球指南权威背书、医保放量，以及独特的机制和确切疗效，耐 赋康有望成为IgA肾病领域的重磅药物。据预测，该药物2025年全年销售额有望达到12亿—14亿元， 2026年有望攀升至24亿—26亿元，长期或冲击50亿元大关。 从全球诊疗格局来看，2025KDIGO指南的发布将加速全球IgA肾病治疗从"支持治疗"向"对因治疗"转 变，也将为耐赋康的临床普及注入强劲动力。对于云顶新耀而言，此次产品纳入国际权威指南，不仅印 证了其在肾病领域创新研发的实力，更为后续商业化布局奠定了坚实基础。 2025KDIGO指南的核心更新：推动"对因治疗" 2025KDIGO指南带来了重 ...

耐赋康®将在第18届IgA肾病国际研讨会（IIgANN 2025）上，展示7项最新真实世界数据。 此次公布的最新数据来自中国多家顶尖医院的临床实践，从多个维度深入探讨了耐赋康®在IgA肾病治 疗中的疗效与安全性。研究结果显示，耐赋康®在"对因治疗、尽早治疗、长期治疗"三个方面均展现出 显著的临床价值。 这些真实世界证据不仅弥补了随机对照试验（RCT）在临床应用场景中的局限性，也进一步充实了"对 因治疗、尽早治疗、长期治疗"的治疗策略。 耐赋康®是目前唯一同时获得国内外指南推荐的IgA肾病对因治疗药物，证实了其作为IgA肾病一线基石 治疗的领导地位。 2025年第18届IgA肾病国际研讨会（IIgANN）将于9月17日至20日在捷克共和国布拉格举行。耐赋康® （布地奈德肠溶胶囊，NEFECON®）在此盛会中将展示7项最新真实世界数据，进一步展现其在相关领 域的深入研究进展。 此次公布的最新数据来自中国多家顶尖医院的临床实践，从多个维度深入探讨了耐赋康®在IgA肾病治 疗中的疗效与安全性。研究结果显示，耐赋康®在"对因治疗、尽早治疗、长期治疗"三个方面均展现出 显著的临床价值：在真实世界用药中，其对因治疗的价值得 ...

耐赋康®将在第18届IgA肾病国际研讨会（IIgANN 2025）上，展示7项最新真实世界数据。 凭借创新的作用机制和突出的临床优势，耐赋康®先后被纳入《2024版KDIGO IgA肾病和IgA血管炎临 床管理实践指南（公开审查版）》以及《中国成人IgA肾病及IgA血管炎临床实践指南（预审版 本）》，成为目前唯一同时获国际与国内指南推荐的IgA肾病对因治疗药物。这不仅改变了传统的IgA 肾病治疗方案，强调对因治疗和支持治疗需同时进行，也确立了耐赋康®作为IgA肾病一线治疗的基石 地位。耐赋康®于2024年11月成功纳入国家医保药品目录，2025年8月其扩产补充申请正式获得中国国 家药品监督管理局批准。 耐赋康®是目前全球首个同时获中国国家药品监督管理局（NMPA）、美国食品药品监督管理局 （FDA）、欧洲药品管理局（EMA）、英国药品和健康产品管理局（MHRA）及云顶新耀其他亚洲授 权区域（中国香港、中国澳门、中国台湾、新加坡及韩国）完全批准的IgA肾病治疗药物。 数据摘要 01 编号：P-45 此次公布的最新数据来自中国多家顶尖医院的临床实践，从多个维度深入探讨了耐赋康®在IgA肾病治 疗中的疗效与安全性。 ...

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]

Core Viewpoint - CloudTop New Horizon (HKEX 1952.HK) announced the approval of its expanded production application for NEFECON (Budesonide Enteric-Coated Capsules), the first and only fully approved IgA nephropathy targeted therapy in China, which will enhance production capacity and meet the growing clinical demand in China and Asia [1][2]. Group 1: Product Approval and Market Impact - NEFECON is the first and only IgA nephropathy targeted therapy fully approved in China, the US, and Europe, establishing it as a cornerstone drug for IgA nephropathy treatment [1][3]. - The approval for expanded production will allow for a more efficient response to the increasing clinical needs of IgA nephropathy patients in Asia, where the disease is highly prevalent [1][2]. - 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 [1][2]. Group 2: Clinical Efficacy and Guidelines - NEFECON has been shown to reduce the risk of kidney function decline by 50% in global Phase III NefIgArd studies, with a 66% reduction observed in the Chinese population [2][5]. - The drug delays the progression to dialysis or kidney transplantation by an average of 12.8 years, highlighting its clinical significance [2][5]. - NEFECON is the only IgA nephropathy targeted therapy recommended by both international and domestic clinical guidelines, solidifying its position as a first-line treatment [3][5]. Group 3: Mechanism of Action - NEFECON works by specifically modulating intestinal mucosal immunity to reduce the production of Gd-IgA1, which triggers IgA nephropathy, thereby effectively controlling proteinuria and protecting kidney function [2][5]. - The formulation includes a unique triple-layer coating that ensures targeted release of Budesonide to the mucosal B cells in the ileum, enhancing its therapeutic effect [5].