据介绍，此次ASN大会公布的研究结合了多项中国真实世界研究(RWS)证据，系统印证了耐赋康通过靶 向肠道黏膜免疫、从源头干预疾病进程的独特价值，为IgA肾病全病程规范化治疗提供了关键循证支 持。超七成中国IgA肾病患者诊断时已存在进展风险，存在治疗启动滞后的问题。目前，中国约有500 万的IgA肾病患者，每年新增确诊患者超过12万人，存在巨大未被满足的临床需求。因此，通过尽早长 期对因治疗延缓疾病进展、保护患者肾功能，对IgA肾病的治疗具有至关重要的意义。 云顶新耀(01952)涨超5%，截至发稿，涨4.07%，报48.56港元，成交额1.58亿港元。 消息面上，据云顶新耀官微消息，在2025年第58届美国肾脏病协会肾脏周(ASN Kidney Week2025)上， 耐赋康(布地奈德肠溶胶囊，NEFECON)展示了多项关于IgA肾病患者的最新研究结果。随着耐赋康在中 国人群中证据的不断积累，这些研究结果进一步证实了在"对因治疗、尽早治疗、长期治疗"IgA肾病新 管理策略中的显著临床价值；耐赋康对特殊人群的疗效也得到验证，巩固了其IgA肾病一线治疗的基石 地位。 ...

Core Viewpoint - Clouding New Horizon (01952) saw a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Company Developments - NEFECON demonstrated substantial clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with existing progression risks, highlighting a delay in treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Insights - The new guidelines recommend a 9-month treatment with Budesonide delayed-release capsules (NEFECON) for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1) [2][3] - NEFECON is the only drug approved for causal treatment of IgA nephropathy that has received recommendations from both international and domestic guidelines [2][4] Industry Overview - The 2025 Chinese guidelines for IgA nephropathy emphasize a "layered and staged" comprehensive treatment approach, highlighting the importance of causal treatment, early intervention, and long-term management [7] - The guidelines focus on pathogenic galactose-deficient IgA1 (Gd-IgA1) as a key factor in disease onset, marking a shift from symptomatic to causal treatment [3][7] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [3] Company Insights - NEFECON has shown efficacy in reducing kidney function decline by 50% globally and can delay kidney function deterioration by up to 66% in the Chinese population, extending the time to dialysis or kidney transplantation by 12.8 years [5] - NEFECON is the first drug for IgA nephropathy to receive full approval from multiple regulatory bodies, including NMPA, FDA, EMA, and others, without baseline proteinuria level restrictions [4] - The drug is designed to target intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA-IC, thereby alleviating immune damage to the kidneys [5]

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]

Core Insights - CloudTop New Drug's NEFECON has been included in the 2025 KDIGO guidelines as the only recommended first-line treatment for IgA nephropathy, solidifying its foundational status in the treatment landscape [1][5][6] - The inclusion in the KDIGO guidelines is expected to accelerate the shift from "supportive treatment" to "causal treatment" for IgA nephropathy globally, providing a strong impetus for the clinical adoption of NEFECON [2][6] Company Summary - NEFECON's unique mechanism of action, targeting pathogenic IgA and IgA immune complexes, aligns with the new treatment strategies outlined in the KDIGO guidelines, which emphasize early intervention and immunological management [5][6] - The drug is projected to achieve sales of 1.2 to 1.4 billion yuan in 2025, increasing to 2.4 to 2.6 billion yuan in 2026, with long-term potential to reach 5 billion yuan [1][2] Industry Summary - The 2025 KDIGO guidelines represent a significant shift in the treatment paradigm for IgA nephropathy, focusing on early diagnosis and treatment, which will likely expand the patient population eligible for treatment [3][4] - The guidelines recommend a 9-month treatment course with NEFECON for patients at risk of renal function decline, with considerations for extending treatment duration to maintain long-term clinical benefits [3][4] - The emphasis on a multi-drug approach and the management of immune-driven renal unit loss indicates a move towards more comprehensive treatment strategies for IgA nephropathy [4][6]

Core Insights - The core product of the company, NEFECON (Budesonide Delayed-Release Capsules), has been included in the 2025 KDIGO guidelines as the only recommended drug for the etiology-based treatment of IgA nephropathy, solidifying its foundational status in this area [1][4]. 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 [2][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 [2][3]. - 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 significantly [2][3]. Market Potential - NEFECON is projected to achieve annual sales of 1.2 to 1.4 billion yuan in 2025, increasing to 2.4 to 2.6 billion yuan in 2026, with long-term potential to exceed 5 billion yuan [1]. - The inclusion of NEFECON in the KDIGO guidelines is anticipated to accelerate the global shift towards etiology-based treatment for IgA nephropathy, providing a strong impetus for clinical adoption [4][5]. Clinical Validation - NEFECON's mechanism aligns with the guidelines' strategy to prevent the formation of pathogenic IgA and IgA immune complexes, which is crucial for reducing renal damage [4]. - Clinical trials and real-world data have demonstrated NEFECON's efficacy in significantly lowering proteinuria levels and delaying renal function decline, particularly in the Chinese patient population, where it can extend the time to dialysis or kidney transplantation by up to 12.8 years [4][5]. Strategic Positioning - The recognition of NEFECON by global kidney disease authorities not only validates the company's innovative research capabilities in the nephrology field but also lays a solid foundation for future commercialization efforts [1][5].

Core Insights - The presentation of NEFECON at the IIgANN 2025 conference highlights its effectiveness and safety in treating IgA nephropathy, particularly after a 9-month treatment followed by a 12-month continuation, providing valuable evidence for long-term management of the disease [1][3] Group 1: Treatment Efficacy and Safety - NEFECON demonstrated significant efficacy in reducing 24-hour urinary protein levels from 1016 mg to 114 mg after 12 months, compared to 291 mg in the control group [3] - The treatment group showed a better change rate in eGFR compared to the control group, with no severe infections reported and only minor side effects observed, indicating good tolerability [3] Group 2: Clinical Need and Market Potential - There are over 5 million IgA nephropathy patients in China, with an annual increase of 100,000 new cases, indicating a pressing clinical need for effective treatments [1][5] - NEFECON's early market entry has allowed it to accumulate substantial real-world evidence, enhancing its competitive edge in terms of efficacy, safety, and accessibility [5] Group 3: Long-term Treatment Strategy - The latest research supports the strategy of "long-term targeted treatment" for IgA nephropathy, emphasizing the importance of maintaining kidney function while controlling proteinuria [3][4] - NEFECON is the first drug approved for IgA nephropathy treatment globally, with full approvals from multiple regulatory bodies, further solidifying its position in the market [3][5] Group 4: Commercial Performance - Following its inclusion in the national medical insurance directory, NEFECON's accessibility has significantly improved, with a monthly shipment volume exceeding 130,000 bottles and sales revenue reaching 520 million yuan in August 2025 [5] - Forecasts suggest that NEFECON's annual sales could exceed 1.2 to 1.4 billion yuan in 2025 and rise to 2.4 to 2.6 billion yuan in 2026, positioning it as a key drug in the field [5]

Core Insights - The 18th International Symposium on IgA Nephropathy (IIgANN2025) showcased real-world research data on NEFECON, a drug by the company, demonstrating its effectiveness and safety for IgA nephropathy patients after a 12-month treatment period [1][3] Group 1: Treatment Efficacy and Safety - NEFECON showed significant improvement in key efficacy indicators, with 24-hour urinary protein levels decreasing from 1016 mg to 114 mg after 12 months, compared to 291 mg in the control group [3] - The treatment group exhibited better eGFR change rates and no severe infections, indicating good tolerability and safety compared to traditional therapies [3] Group 2: Market Potential and Demand - There are over 5 million IgA nephropathy patients in China, with 100,000 new diagnoses annually, highlighting a pressing clinical need [1][5] - NEFECON's early market entry has allowed it to accumulate substantial real-world evidence, enhancing its effectiveness, safety, and accessibility compared to recently approved competitors [5] Group 3: Long-term Treatment Strategy - The latest research supports the long-term treatment strategy for IgA nephropathy, emphasizing the need for ongoing therapy after initial treatment to maintain kidney function [3][4] - NEFECON is the first drug approved for IgA nephropathy with a focus on long-term causal treatment, aligning with new clinical guidelines [3][4] Group 4: Commercial Performance - Following its inclusion in the national medical insurance directory, NEFECON's accessibility has significantly improved, with a monthly shipment volume exceeding 130,000 bottles and sales revenue reaching 520 million yuan in August 2025 [4][5] - Projected annual sales for NEFECON are expected to exceed 1.2 to 1.4 billion yuan in 2025 and rise to 2.4 to 2.6 billion yuan in 2026, indicating its potential as a blockbuster drug in the field [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]