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《2025 KDIGO 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12-14亿元， 2026年有望攀升至24-26亿元，长期或冲击50亿元大关。 2025 KDIGO指南的核心更新：推动"对因治疗" 2025 KDIGO指南带来了重大变化，将IgA肾病的治疗从"支持治疗"推向"对因治疗"阶段，确立了耐赋康 ®作为一线对因治疗药物的地位。指南明确推荐，所有存在肾功能衰退风险的IgA肾病患者应接受为期9 个月的布地奈德肠溶胶囊治疗，此外指出，9个月的疗程可能不足以维持长期的临床获益， ...

（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]

【云顶新耀：耐赋康®被纳入《2025 KDIGO IgA肾病和IgA血管炎临床实践管理指南》 成为指南唯一推 荐的IgA肾病一线对因治疗药物】智通财经9月19日电，据云顶新耀官微19日消息，云顶新耀耐赋康® （布地奈德肠溶胶囊，NEFECON®）被纳入由改善全球肾脏病预后组织（KDIGO）发布的《2025 KDIGO IgA肾病和IgA血管炎临床管理实践指南》(以下简称"指南")，推荐对所有有肾功能进行性衰退 风险的IgA肾病患者进行9个月的耐赋康®治疗，明确其一线用药地位。指南同时也强调单次9个月的疗 程可能不足以在长期降低蛋白尿和稳定估算肾小球滤过率（eGFR）方面维持持续的临床获益，因此需 要延长治疗时间（长期治疗数据正在完善中）。 转自：智通财经 ...

经济观察网 据云顶新耀微信公众号9月18日消息，在2025年第18届IgA肾病国际研讨会（IIgANN 2025） 上，耐赋康®（布地奈德肠溶胶囊，NEFECON®）展示了7项来自中国多家顶尖医院的最新真实世界研 究数据。其中一项重要的观察性研究评估了耐赋康®治疗IgA肾病12个月的有效性和安全性，其结果证 实了耐赋康®在"长期对因治疗"IgA肾病方面具有显著临床获益。 ...

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]

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 latest research confirms that Nefecon® significantly reduces kidney function deterioration by 50% through its positive effects on the first three hits in the "four-hit" model of IgA nephropathy [1][3][4]. Group 1: Efficacy and Mechanism - Nefecon® has been shown to significantly lower levels of Gd-IgA1, IgG anti-IgA antibodies, and IgA immune complexes (IgA-IC), indicating its effectiveness across multiple pathogenic pathways [1][3][4]. - Changes in Gd-IgA1 or polymeric IgA within the first two months of treatment are significantly correlated with reductions in proteinuria, suggesting these biomarkers could guide Nefecon® therapy [1][3][7]. - The NefIgArd trial involved 216 participants and demonstrated that Nefecon® effectively targets the gut to modulate immune responses, thereby reducing pathogenic IgA levels [4][5]. Group 2: Clinical Significance - Nefecon® is the first and only drug approved for the causal treatment of IgA nephropathy in China, the U.S., and Europe, and is recommended in multiple clinical guidelines, solidifying its position as a cornerstone therapy [2][4]. - The drug's ability to intervene at the source of IgA nephropathy's pathogenesis is expected to reshape treatment strategies and provide more options for a broader patient population [4]. Group 3: Patient Impact - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new cases diagnosed annually, highlighting the significant healthcare burden and the need for effective treatments like Nefecon® [3].