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 [1][1][1] Company Summary - NEFECON is recognized as a disease-modifying treatment for IgA nephropathy, which is characterized by the deposition of IgA immune complexes in the kidneys, leading to inflammation and potential chronic kidney failure [1][1] - The inclusion in the KDIGO guidelines provides new treatment options for the approximately 5 million IgA nephropathy patients in China, with over 120,000 new cases diagnosed annually [1][1][1] Industry Summary - The KDIGO guidelines emphasize early intervention, precise treatment, and improved prognosis, representing a milestone in the clinical management of IgA nephropathy [1][1] - The guidelines highlight the need to manage specific factors driving kidney unit loss and stress the importance of intervening at the source of pathogenic immune complex formation to reduce kidney immune damage [1][1][1] - The shift towards "etiological treatment" as a mainstream approach is expected to change the treatment landscape for IgA nephropathy, reducing the risk of progression to end-stage kidney disease for patients [1][1]

不仅如此，2025年指南还对诊断时机、治疗时机、治疗目标等方面进行了优化。例如，在诊断时机方 面，指南明确指出，当蛋白尿≥0.5g/d时，疑似IgA肾病患者应进行肾活检，并尽早开始治疗。诊断时机 和治疗窗口的前移，意味着未来IgA肾病患者的治疗人群将会明显扩大。 （原标题：云顶新耀耐赋康®被纳入2025 KDIGO指南，成唯一推荐的IgA肾病一线对因治疗药物） 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12亿—14亿元， 2026年有望攀升至24亿—26亿元，长期或 ...

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 ...

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。 ...

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。 ...

（原标题：云顶新耀耐赋康®亮相IIgANN 2025：9个月疗程后延续用药12个月，IgA肾病患者持续获益 获真实世界数据印证） 9月17日，第18届IgA肾病国际研讨会（IIgANN 2025）在捷克布拉格开幕。云顶新耀旗下耐赋康（布地 奈德肠溶胶囊，NEFECON）在会上展示7项中国顶尖医院最新真实世界研究数据，其中12个月治疗有 效性与安全性的观察性研究，不仅为IgA肾病患者9个月疗程后的后续治疗提供了清晰方向，而且为lgA 肾病患者的长期治疗提供了极具价值的循证医学支持，进一步巩固其一线治疗基石地位。 当前，中国IgA肾病患者存量超500万，年新增确诊10万例，临床需求迫切。耐赋康相较于其他刚获批 的竞品，凭借更早上市的先发优势，已积累了更丰富的真实世界应用证据，在有效性、安全性与临床可 及性上形成优势。随着长期治疗证据的逐步落地、医保覆盖的持续深化，其市场潜力将进一步释放。 9个月疗程后延续用药12个月，疗效与安全性获验证 IgA肾病作为全球最常见慢性自身免疫性肾小球疾病，隐匿起病且疾病负担沉重，亚洲人群尤为高发。 数据显示，亚洲人进展至终末期肾病的风险较其他人群高56%，且疾病进展更快；在中国，其 ...

9个月疗程后延续用药12个月，疗效与安全性获验证 IgA肾病作为全球最常见慢性自身免疫性肾小球疾病，隐匿起病且疾病负担沉重，亚洲人群尤为高发。 数据显示，亚洲人进展至终末期肾病的风险较其他人群高56%，且疾病进展更快；在中国，其是青壮年 肾衰主因之一，约60%患者确诊后15年内会进展至终末期肾病，给家庭与社会带来多重压力。 在耐赋康获批前，国内治疗方案以肾素-血管紧张素系统抑制剂支持性治疗及不规范使用激素和免疫抑 制剂为主，存在疗效有限、副作用明显等问题，患者难坚持长期治疗以保护肾功能。 9月17日，第18届IgA肾病国际研讨会(IIgANN2025)在捷克布拉格开幕。云顶新耀旗下耐赋康(布地奈德 肠溶胶囊，NEFECON)在会上展示7项中国顶尖医院最新真实世界研究数据，其中12个月治疗有效性与 安全性的观察性研究，不仅为IgA肾病患者9个月疗程后的后续治疗提供了清晰方向，而且为lgA肾病患 者的长期治疗提供了极具价值的循证医学支持，进一步巩固其一线治疗基石地位。 当前，中国IgA肾病患者存量超500万，年新增确诊10万例，临床需求迫切。耐赋康相较于其他刚获批 的竞品，凭借更早上市的先发优势，已积累了更丰富的 ...

Core Insights - The studies presented at the 62nd European Renal Association (ERA 2025) conference confirm the efficacy of Nefeccon (Budesonide delayed-release capsules) in protecting kidney function across various baseline eGFR levels and different pathological changes in patients with IgA nephropathy [2][3][5] Study Findings - The NefIgArd study sub-analysis demonstrated that Nefeccon significantly reduces baseline urine protein-to-creatinine ratio (UPCR) regardless of the baseline eGFR level, showing protective effects on eGFR at all time points [3][6] - A second multicenter study focused on the treatment benefits for IgA nephropathy patients with different pathological manifestations, revealing that after 9 months of Nefeccon treatment, patients exhibited significant reductions in urine protein and stable eGFR, particularly in those with endothelial cell proliferation (E1) and/or crescent formation (C1) [4][10] Clinical Implications - Nefeccon is the first and only IgA nephropathy treatment approved in China, the US, and Europe that is not limited by proteinuria levels, supporting a "treat all" strategy for kidney protection in IgA nephropathy patients [2][5] - The findings provide strong evidence for early initiation of cause-targeted therapy upon diagnosis to protect kidney function and improve overall prognosis for all patients [3][10] Market Context - The prevalence of IgA nephropathy is significantly higher in Asia, with an estimated 5 million patients in China and over 100,000 new cases diagnosed annually, indicating a substantial unmet clinical need [4][5]

Core Viewpoint - The latest research presented at the ERA 2025 conference demonstrates that NefECON (budesonide delayed-release capsules) provides significant clinical benefits when used early in the treatment of IgA nephropathy, supporting a new management strategy focused on early and targeted treatment [1][2][3] Group 1: Research Findings - Eight oral presentations and one electronic poster were showcased, with two studies confirming the clinical benefits of early treatment with NefECON for IgA nephropathy [1] - A sub-analysis of the NefIgArd study indicated that budesonide significantly reduces proteinuria and protects kidney function across different diagnosis times, with more pronounced benefits in patients diagnosed within 0.6 years [2][3] - A prospective study showed that early use of budesonide not only reduces pathogenic IgA production but also may help control inflammatory responses, thereby slowing disease progression [2] Group 2: Clinical Implications - The findings emphasize the importance of early intervention in IgA nephropathy treatment, providing strong evidence for clinical practice [2] - The 2025 version of the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis" in China recommends budesonide as the first choice for reducing pathogenic IgA [2] - NefECON has been included in both the KDIGO and Chinese clinical practice guidelines, highlighting its significance as a treatment option [12] Group 3: Company Positioning - NefECON is the first and only drug for targeted treatment of IgA nephropathy approved in China, the US, and Europe, marking a shift in treatment standards [2][12] - The drug has shown the potential to delay kidney function decline by 66% in the Chinese population and extend the time to dialysis or kidney transplant by 12.8 years [13] - The company has secured full approval for NefECON in China, removing previous restrictions related to proteinuria levels [2]

Core Viewpoint - The release of the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" marks a significant advancement in the treatment of IgA nephropathy, with the inclusion of NEFECON as a recommended therapy for patients at risk of disease progression [1][2][3] Group 1: Guidelines and Recommendations - The guidelines emphasize the need for etiology-based treatment, early intervention, and comprehensive management strategies for IgA nephropathy patients in China [2] - For patients with proteinuria ≥0.5g/d, kidney biopsy and treatment initiation are recommended, aiming for proteinuria <0.5g/d and an estimated glomerular filtration rate (eGFR) decline of less than 1ml/min per year [2] - The guidelines introduce blood urine monitoring and suggest interventions targeting immune damage, including the use of NEFECON to reduce pathogenic IgA levels [2] Group 2: NEFECON's Clinical Significance - NEFECON is recognized as the only etiology-based treatment for IgA nephropathy, establishing its position as a first-line therapy in global kidney disease guidelines [3][4] - The NefIgArd study demonstrated that NEFECON significantly reduces the risk of kidney function decline, with a 50% reduction in eGFR decline compared to placebo, and up to 66% in the Chinese population [4] - NEFECON's approval by the National Medical Products Administration (NMPA) and its inclusion in the national medical insurance drug list further solidify its role in treating IgA nephropathy [4][5]