Core Insights - YunTing New Drug's core product, Naisukan (Budesonide enteric-coated capsules), has demonstrated clinical value in the new management strategy for IgA nephropathy, focusing on "etiological treatment, early treatment, and long-term treatment" [1][3] - The drug has shown effectiveness in special populations, including patients with severe renal impairment and children, reinforcing its position as a first-line treatment for IgA nephropathy [1] - The cumulative sales revenue of Naisukan reached nearly 1 billion yuan from January to September this year, marking it as one of the fastest-growing chronic disease innovative drugs in recent years [2] Group 1 - The real-world studies presented at ASN Kidney Week 2025 validate the clinical advantages of Naisukan, with evidence supporting its efficacy in early treatment for patients with proteinuria levels below 0.5g/d [1][2] - The introduction of Naisukan into the National Medical Insurance Directory in 2024 is expected to activate clinical demand significantly, with the reimbursement policy effective from January 1, 2025 [2] - YunTing New Drug is developing diagnostic testing reagents for IgA nephropathy, which are expected to fill the gap in non-invasive diagnosis in China, potentially replacing kidney biopsy as an auxiliary diagnostic method [2] Group 2 - The company anticipates that the deepening of clinical consensus and insurance coverage will enhance the market penetration of Naisukan, making it a core pillar for the company's performance growth [3] - The new management strategy for IgA nephropathy aims to provide patients with hope for delaying disease progression and improving long-term outcomes [3] - The clinical data for the next-generation BTK inhibitor EVER001 is promising, indicating potential coverage for a broader range of kidney disease indications [2]

近日，2025年第58届美国肾脏病协会肾脏周(ASN Kidney Week2025)上，云顶新耀(01952.HK)核心产品 耐赋康(布地奈德肠溶胶囊)展示的多项中国真实世界研究(RWS)结果，受到行业关注。这些数据不仅验 证了该药物在IgA肾病"对因治疗、尽早治疗、长期治疗"新管理策略中的核心价值，也证实了其对特殊 人群的疗效，进一步巩固了其一线治疗地位。叠加中外指南背书与医保政策红利，这款全球首款IgA肾 病对因治疗药物正加速市场渗透，成为推动云顶新耀商业化增长的关键动力。 在业内看来，耐赋康在早期、重症、儿童及难治性病例中均展现出显著的降蛋白尿、改善血尿、保护肾 功能的疗效，无论患者基线肾功能、蛋白尿水平或既往治疗反应如何，均能提供个体化对因治疗选择， 其作为IgA肾病治疗的一线基石药物的地位日益巩固。 扎实的临床证据为耐赋康的商业化推广铺路，而医保政策的落地则加快了市场普及。2025年以来， 《2025KDIGO IgA肾病和IgA血管炎临床管理实践指南》《中国成人IgA肾病及IgA血管炎临床实践指南 (2025)》均明确推荐对因治疗，其中《2025KDIGO指南》将耐赋康列为唯一推荐的IgA肾病一 ...

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]