本报讯(记者金婉霞)近日，在2025年第58届美国肾脏病协会肾脏周(ASN Kidney Week2025)上，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")发布了核心产品耐赋康(布地奈德肠溶胶囊)的 多项中国真实世界研究(RWS)结果，不仅系统验证了该药物在"对因治疗、尽早治疗、长期治疗"IgA肾 病新管理策略中的临床价值，还论证了该药物对特殊人群的疗效，进一步巩固了其IgA肾病一线治疗的 基石地位。 在单一产品放量的同时，云顶新耀正围绕IgA肾病构建诊疗一体闭环。目前，云顶新耀正在针对lgA肾 病开发检测试剂，该检测试剂的临床研究正在推进患者入组工作，预计2026年获批上市，将填补国内 IgA肾病无创诊断空白，有望替代肾活检辅助诊断。此外，针对原发性膜性肾病的新一代BTK抑制剂 EVER001临床数据积极，有望覆盖更广泛的肾病适应症。 云顶新耀方面表示，此次在ASN2025公布的新数据，再次验证了耐赋康的临床优势。随着中外指南推荐 及医保覆盖深化，耐赋康的临床用药共识将进一步强化，叠加医保政策红利与产能释放，其市场渗透率 有望持续提升。未来，该产品不仅将成为云顶新耀业绩增长的核心支柱，更将 ...

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 article discusses the recent trends and developments in the pharmaceutical industry, particularly focusing on the performance of innovative drug companies and their clinical trials [5][11][18]. Group 1: Market Performance - The pharmaceutical and biotechnology indices experienced a decline, with the pharmaceutical index dropping by 1.21%, underperforming the Shanghai Composite Index by 0.91 percentage points [5]. - The Hang Seng Healthcare Index fell by 1.55%, and the Hong Kong innovative drug ETF decreased by 1.52% during the same period [5]. Group 2: Company Developments - Xianweida Biotechnology submitted an A1 listing application to the Hong Kong Stock Exchange, with cumulative losses exceeding 1 billion yuan over the past two and a half years [6][7]. - Xianweida's core product, Ecnoglutide, is expected to submit applications for overweight/obesity and type 2 diabetes indications by the end of 2024, with anticipated approval in early 2026 [7][8]. - The company reported no revenue for 2023 and 2024, with losses of 620 million yuan and 486 million yuan, respectively [8]. Group 3: Clinical Trials - Bai Li Tianheng's ADC drug BL-M07D1 has entered a phase III clinical trial for HER2-positive gastric cancer, with a focus on overall survival and progression-free survival as primary endpoints [15][16]. - The SLIMMER study, a significant phase III trial for Ecnoglutide, showed that participants could lose up to 13.8 kg over 48 weeks, with minimal weight regain after stopping the treatment [7]. Group 4: Stock Market Dynamics - The stock of Yaojie Ankang-B experienced extreme volatility, with a price drop from 679.5 HKD to 192 HKD per share, reflecting the high-risk nature of the Hong Kong market for uncommercialized biotech firms [12][13]. - The market's reaction to Yaojie Ankang-B's inclusion in the Hong Kong Stock Connect innovative drug index raised concerns about the decision-making process for including emerging companies in such indices [13]. Group 5: Regulatory Recognition - Yunding Xinyao's core product, Budesonide enteric-coated capsules, has been included in the global kidney disease guidelines, marking it as the only recommended treatment for IgA nephropathy [18].

Core Insights - A significant observational study confirms that NEFECON (budenoside enteric-coated capsules) provides substantial clinical benefits in the "etiological treatment" of IgA nephropathy, supporting a new management strategy focused on early and long-term treatment [1][4] Group 1: Study Findings - After 12 months of treatment, the NEFECON group showed a reduction in 24-hour urinary protein from 1016 mg to 114 mg, significantly lower than the control group's 291 mg [3] - The estimated glomerular filtration rate (eGFR) slope in the NEFECON group was significantly better than the control group, at 5.4 ml/min/1.73m²/year compared to -3.4 ml/min/1.73m²/year [3] - No severe infections occurred in the NEFECON group, indicating a better safety profile compared to traditional treatments [3] Group 2: Clinical Implications - The 2025 version of the "Clinical Practice Guidelines for Adult IgA Nephropathy" emphasizes the importance of long-term treatment strategies, including immunotherapy, to maintain kidney function and reduce the risk of renal failure [4] - NEFECON is the only approved drug for the etiological treatment of IgA nephropathy, recommended by both domestic and international guidelines for its ability to intervene at the disease's source [4][5] - The latest real-world study results presented at IIgANN 2025 reinforce NEFECON's position as a cornerstone treatment for IgA nephropathy, demonstrating sustained patient benefits after extending treatment beyond the initial 9 months [4][5] Group 3: Market Context - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, highlighting a significant unmet clinical need [5] - NEFECON is the first and only drug for IgA nephropathy to receive full approval in China, the US, and Europe, not limited by urinary protein levels, thus reshaping treatment pathways for this condition [5]

Core Insights - The presentation at the IIgANN2025 highlighted the significant clinical benefits of NEFECON (budesonide delayed-release capsules) for the long-term treatment of IgA nephropathy, supported by real-world data from top hospitals in China [1][2][3] Group 1: Treatment Efficacy - A retrospective study demonstrated that after 12 months of treatment with budesonide, patients showed a significant reduction in 24-hour urinary protein from 1016 mg to 114 mg, compared to 291 mg in the control group [2][3] - The estimated glomerular filtration rate (eGFR) slope for the budesonide group was significantly better at 5.4 ml/min/1.73m²/year versus -3.4 ml/min/1.73m²/year in the control group, indicating better kidney function preservation [2][3] - The study confirmed that budesonide treatment had a favorable safety profile, with no serious infections reported [2][3] Group 2: Clinical Guidelines and Recommendations - The 2025 version of the clinical practice guidelines for IgA nephropathy emphasizes the importance of controlling proteinuria in the short term and maintaining kidney function in the long term, highlighting the role of immunotherapy [3] - Budesonide is the only approved disease-modifying treatment for IgA nephropathy, recommended by both domestic and international guidelines for its mechanism of action in reducing pathogenic IgA production [3][4] Group 3: Market and Patient Demographics - 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 [4] - NEFECON is the first and only disease-modifying treatment for IgA nephropathy approved in China, the US, and Europe, not limited by proteinuria levels, thus reshaping treatment pathways for patients [4]

Core Insights - The latest real-world study data on NEFECON® (Budesonide delayed-release capsules) presented at the 2025 IIgANN conference demonstrates significant clinical benefits for IgA nephropathy patients through long-term targeted therapy [1][3][4] Group 1: Study Findings - A retrospective study evaluated the efficacy and safety of 12 months of Budesonide treatment in IgA nephropathy patients, showing a reduction in 24-hour urinary protein from 1016 mg to 114 mg, significantly lower than the control group [2][3] - The eGFR slope in the Budesonide group was significantly better than the control group, with rates of 5.4 ml/min/1.73m²/year versus -3.4 ml/min/1.73m²/year [2][3] - No serious infections occurred in the Budesonide group, indicating a favorable safety profile compared to traditional treatments [2][3] Group 2: Clinical Implications - The treatment of IgA nephropathy should focus on short-term proteinuria control and long-term kidney function stability, as emphasized in the 2025 guidelines [3] - Budesonide is the only approved targeted therapy for IgA nephropathy, recommended by both domestic and international guidelines for its mechanism of reducing pathogenic IgA production [3][4] - The study reinforces Budesonide's role as a cornerstone treatment for IgA nephropathy, highlighting the necessity of long-term targeted therapy in disease management [3][4] Group 3: Market Context - 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 [4] - NEFECON® is the first and only targeted therapy for IgA nephropathy approved in China, the US, and Europe, not limited by proteinuria levels, thus reshaping treatment pathways for patients [4]

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 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 - Yunding Xinyao's core product, Nefukang (Budesonide enteric-coated capsules), has received approval from the National Medical Products Administration (NMPA) for production expansion, marking a significant step in addressing the clinical demand for IgA nephropathy treatment in China [1][2]. Group 1: Product and Market Demand - IgA nephropathy is a common primary glomerular disease with over 5 million patients in China, and more than 100,000 new cases diagnosed annually, indicating a high unmet clinical need [1]. - Nefukang has a unique mechanism that regulates intestinal mucosal immunity, reducing the production of Gd-IgA1, which is implicated in IgA nephropathy, effectively controlling proteinuria and protecting kidney function [1]. - Clinical data from the global Phase III NefIgArd study shows that Nefukang can reduce the risk of kidney function decline by 50%, with a 66% delay in kidney function deterioration for the Chinese population, potentially postponing the need for dialysis or kidney transplant by 12.8 years [1]. Group 2: Regulatory and Commercialization Progress - Nefukang has been included in both international and domestic clinical management guidelines, making it the only IgA nephropathy treatment recommended by both [2]. - Following its approval in November 2023, Nefukang filled a gap in the treatment of IgA nephropathy at the disease source and is expected to be included in the national medical insurance drug list by November 2024, expanding its eligible patient population threefold [2]. - The surge in market demand has led to supply constraints in Q2 2023, prompting the production expansion to address this issue and potentially serve as a turning point for Yunding Xinyao's performance [2]. Group 3: Future Potential and Strategic Developments - Nefukang's first full-year sales are projected to exceed 1 billion yuan, positioning it as one of the fastest-growing chronic disease drugs in China, with peak sales estimates reaching 5 billion yuan [3]. - Yunding Xinyao also has a next-generation covalent reversible BTK inhibitor, EVER001, which is expected to address broader kidney disease areas and fill several global clinical gaps [3]. - The ongoing clinical research for the Gd-IgA1 diagnostic reagent aims to replace kidney biopsy for auxiliary diagnosis, creating a "diagnosis-treatment" loop that enhances the precision and effectiveness of kidney disease treatment [3].

Group 1 - The approval of the expanded production application for the drug Nefikang (Budesonide Enteric-Coated Capsules) marks it as the first and only fully approved treatment for IgA nephropathy in China, enhancing its supply to meet the growing clinical demand in Asia [1] - The CEO of the company emphasized that the increased production capacity will better address the rising clinical treatment needs of IgA nephropathy patients in Asia, particularly in China, which has the highest incidence of primary glomerular diseases globally, with over 5 million patients and more than 100,000 new cases diagnosed annually [1] - Nefikang is currently the only drug recommended by both domestic and international guidelines for the treatment of IgA nephropathy, and its expanded production will accelerate the adoption of targeted treatment, helping more patients initiate standardized treatment early to delay disease progression and protect kidney function [1] Group 2 - Nefikang received formal approval from the NMPA in November 2023 through a priority review process for treating adult patients with primary IgA nephropathy at risk of progression, filling a gap in the domestic treatment landscape [2] - The drug was included in the National Medical Insurance Drug List in November 2024 and received full NMPA approval in May 2025, removing restrictions on proteinuria levels, making it applicable to the majority of IgA nephropathy patients [2] - Nefikang has been incorporated into both the 2024 KDIGO Clinical Practice Guidelines for IgA Nephropathy and the Chinese Clinical Practice Guidelines for Adult IgA Nephropathy, establishing it as a cornerstone treatment for IgA nephropathy [2]