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]

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Event**: Conference Call at TD Cowen I&I Summit on November 13, 2025 Key Industry Insights - **Focus**: IgA nephropathy treatment and clinical trial results - **Recent Achievements**: Presentation at ASN and publication in the New England Journal of Medicine [1][2] Core Findings from Clinical Trials - **Phase 2b Results**: - Two-thirds reduction in autoantigen over two years [3] - 75% of patients showed resolution of hematuria [3] - Over 50% reduction in proteinuria, a key FDA measure for accelerated approval [4] - Annual rate of loss of GFR was -0.6 mL/min, comparable to healthy population [4] - **Phase 3 Results**: - 46% reduction in proteinuria for atacicept-treated patients vs. 7% for placebo [4] - Placebo-adjusted reduction in proteinuria was 42%, exceeding the FDA's 30% threshold [5] - Consistent efficacy across various patient subgroups, including age, sex, and race [5][12] - **Safety Profile**: - Favorable safety data comparable to placebo, with no evidence of opportunistic infections [9][30] - Mild injection site reactions were self-limited [10] Regulatory and Market Position - **BLA Submission**: Submitted to FDA, with anticipation of bringing the new medicine to market next year [2][12] - **Market Strategy**: Confidence in leading position due to comprehensive data set and positive patient experience [14][21] Competitive Landscape - **Comparison with Competitors**: - Discussion on differential efficacy between atacicept and competitor Sibeprenlimab, particularly regarding proteinuria reduction [11][20] - Emphasis on the strength of atacicept's data set in the context of other B-cell modulating drugs [23] Future Directions - **Pioneer Basket Study**: Phase 2 program focusing on IgA nephropathy and other autoimmune kidney diseases, with data expected in 2026 [31][32] - **Long-term Goals**: Aim to stabilize GFR and reduce the need for dialysis or transplant in patients [19][26] Additional Considerations - **Hematuria as a Marker**: Early reduction in hematuria indicates anti-inflammatory benefits and potential long-term kidney function preservation [18][19] - **Hypogammaglobulinemia Concerns**: No significant findings in atacicept program, contrasting with other drugs in the class [28][30] This summary encapsulates the critical insights and data shared during the conference call, highlighting Vera Therapeutics' advancements in treating IgA nephropathy and its strategic positioning in the market.

Core Viewpoint - Rongchang Biopharma (09995) saw a stock increase of over 7%, reaching 109.4 HKD with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy, significantly reducing proteinuria levels [1][1][1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE announced that Taitasip is proposed for priority review for treating IgA nephropathy, which poses a risk of progression [1] - On August 27, Rongchang Biopharma reported that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1][1][1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, acting as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1][1][1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taizhisip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Company Developments - On September 28, the CDE announced that Rongchang Biologics' Taizhisip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics reported that the Phase III study of Taizhisip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Drug Mechanism - Taizhisip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taizhisip can reduce B cell proliferation, lower plasma cell counts, and decrease abnormal immunoglobulin production, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, currently at 109.4 HKD, with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics announced that the Phase III study of Taitasip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

Core Viewpoint - Genting Yongying (01952) has seen a significant increase in stock price, attributed to the approval of production expansion for its core product, Naisfankang, and its inclusion in a global kidney disease management guideline, indicating a strategic shift in treatment options for IgA nephropathy patients [1] Group 1: Financial Performance - Genting Yongying's stock rose over 6%, currently up 5.39% at HKD 57.65, with a trading volume of HKD 300 million [1] - Naisfankang's sales revenue reached HKD 520 million in August, with a shipment volume exceeding 100,000 bottles, marking a new monthly high since its launch [1] - The company has raised its revenue guidance for the full year 2025 to HKD 1.2-1.4 billion, with expectations to further increase it to HKD 2.4-2.6 billion in 2026 [1] Group 2: Product Development and Market Position - The production expansion application for Naisfankang was approved by the National Medical Products Administration in early August, allowing the company to resume its sales growth [1] - On September 19, Genting Yongying announced that Naisfankang was included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended treatment for IgA nephropathy in the guideline [1] - The inclusion in the KDIGO guidelines is seen as a significant milestone, providing new treatment options for IgA nephropathy patients and indicating a shift in global treatment strategies [1]

Core Viewpoint - CloudTop New Horizon (01952) has seen a significant increase in stock price, rising over 6% in the afternoon trading session, attributed to the approval of production expansion for its core product, Naisukan, and its inclusion in a global kidney disease management guideline [1] Group 1: Financial Performance - Naisukan's sales revenue reached 520 million yuan in August, marking a record high for monthly sales since its launch, with over 100,000 bottles shipped [1] - The company has raised its revenue guidance for the full year 2025 to 1.2-1.4 billion yuan, with expectations to further increase to 2.4-2.6 billion yuan in 2026 [1] Group 2: Regulatory and Market Developments - The production expansion application for Naisukan was approved by the National Medical Products Administration in early August, allowing the company to resume its sales growth [1] - On September 19, Naisukan was included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended treatment for IgA nephropathy in the guideline, indicating a shift in global treatment strategies [1]

Group 1 - The 18th International IgA Nephropathy Symposium (IIgANN 2025) will be held in Prague, Czech Republic, from September 17 to 20, 2025, where Frontier Biotech will present preclinical data for its dual-target small nucleic acid drug FB7011 for the first time [1] - FB7011 targets key proteins MASP-2 and CFB in the complement system, showing over 95% inhibition of both targets in a single subcutaneous dose (6 mg/kg) in crab-eating monkeys, with effects lasting over 12 weeks, indicating potential for dosing every 4-6 months in humans [1] - FB7011 demonstrated significant improvement in disease progression indicators (uTP, uPCR, and eGFR) in crab-eating monkey models of IgA nephropathy, with low off-target risk and good safety profile [1] Group 2 - Another drug, FB7013, shows promising preclinical data as a first-in-class targeted MASP-2 small nucleic acid drug, with sustained target protein reduction for 16 weeks after a single subcutaneous dose in healthy monkeys, and effective disease progression inhibition in crab-eating monkey models after 8 weeks [2] - Both FB7011 and FB7013 have novel mechanisms of action, with no similar small nucleic acid drugs approved or in clinical trials globally, presenting significant differentiation advantages [2] - The International IgA Nephropathy Network expert committee highlighted the importance of FB7013 as the first siRNA drug targeting MASP-2, with potential to change treatment regimens if clinical data supports its efficacy [3] Group 3 - IgA nephropathy is the most common primary glomerulonephritis globally, with over 10.2 million patients expected by 2030, and a significant burden on healthcare systems due to high treatment costs [4] - The urgent need for safe, effective, and convenient treatments for IgA nephropathy presents a vast market opportunity, which Frontier Biotech aims to address with its dual-target small nucleic acid drug [4] - The company is accelerating clinical development of its products to provide breakthrough treatment options for this "silent epidemic" [4]

Core Insights - The article highlights the presentation of real-world research data on NEFECON® (Budesonide Delayed-Release Capsules) at the 18th International IgA Nephropathy Symposium (IIgANN 2025) [1] - A significant observational study demonstrated the efficacy and safety of NEFECON® in treating IgA nephropathy over a 12-month period, confirming its substantial clinical benefits for long-term treatment [1] Company Insights - NEFECON® is showcased as a promising treatment option for IgA nephropathy, with data from multiple top hospitals in China [1] - The research emphasizes the importance of real-world evidence in supporting the clinical use of NEFECON® [1] Industry Insights - The presentation at the symposium indicates a growing interest in innovative treatments for IgA nephropathy within the nephrology field [1] - The findings may influence future treatment guidelines and patient management strategies for IgA nephropathy [1]