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， ...

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 ...

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。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(01952)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。 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到验证；早期干预被证实对减少蛋白尿和稳定肾 功能方面具有重要意义；同时，超过9个月的延长治疗数据也提供了长期疗效与安全性的有力证据。 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，强化了耐赋康作为全 ...

Core Insights - The 62nd European Renal Association Congress (ERA2025) showcased innovative drug developments in the field of kidney disease treatment, highlighting significant advancements from companies like YunTing Xinyao [1][8] - YunTing Xinyao's two major therapies, Nanfukang for IgA nephropathy and the covalent reversible BTK inhibitor EVER001 for primary membranous nephropathy, received considerable attention due to their promising clinical trial results [1][3] Group 1: EVER001 Clinical Trial Results - EVER001 demonstrated high clinical remission rates in both low and high dose groups during its 1b/2a clinical trials, with overall safety and tolerability being favorable [1][4] - The drug showed a significant reduction in anti-PLA2R autoantibodies, with decreases of 62.1% and 87.3% at 12 weeks for low and high dose groups respectively, and around 93% at 24 weeks [4] - The potential market for EVER001 is substantial, with over 10 million patients globally suffering from related autoimmune kidney diseases, indicating its potential as a blockbuster drug [3][9] Group 2: Nanfukang's Position in Treatment - Nanfukang is the first and only fully approved drug for the treatment of IgA nephropathy, reinforcing its leading position in first-line therapy and reshaping treatment standards [2][5] - Recent studies presented at the congress highlighted significant clinical benefits of early treatment with Nanfukang, showing greater reductions in proteinuria and improved kidney function [6][7] - The drug's efficacy in reducing markers associated with the pathogenesis of IgA nephropathy further solidifies its role in "etiological treatment" strategies [6][7] Group 3: Market Potential and Strategic Developments - YunTing Xinyao's strategic focus on kidney disease is deepening, with both Nanfukang and EVER001 positioned as key products in their portfolio [8][10] - Nanfukang is expected to reach peak sales of approximately 5 billion yuan, with ongoing clinical research supporting its market expansion [8] - The company is also advancing a Gd-IgA1 diagnostic reagent, which aims to enhance treatment precision by creating a "diagnosis-treatment" loop alongside Nanfukang [9][10]