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]

Core Insights - The article highlights the presentation of real-world research data by Nephron (NEFECON) 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] Group 1 - NEFECON showcased seven real-world research studies from top hospitals in China [1] - The observational study specifically evaluated the effectiveness and safety of NEFECON in IgA nephropathy treatment [1] - Results indicated significant clinical benefits of NEFECON for long-term treatment of IgA nephropathy [1]

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 - CloudTop New Horizon announced that it will present seven new real-world data studies at the 18th International Symposium on IgA Nephropathy from September 17 to 20, highlighting the clinical value of its treatment in IgA nephropathy [1] Group 1: Clinical Efficacy - The research results demonstrate significant clinical value in "etiological treatment, early intervention, and long-term treatment" [1] - Real-world medication confirms the value of etiological treatment [1] - Early intervention is proven to be important for reducing proteinuria and stabilizing kidney function [1] Group 2: Long-term Data - Over nine months of extended treatment data provides strong evidence for long-term efficacy and safety [1] - The evidence addresses the limitations of randomized controlled trials (RCTs) in clinical application scenarios [1] - The findings enrich treatment strategies for IgA nephropathy [1]

Core Insights - The 18th International Symposium on IgA Nephropathy (IIgANN) will be held in Prague, Czech Republic, from September 17 to 20, 2025, where Nefecon will showcase seven new real-world data studies highlighting its research advancements in the field [1] - Nefecon is the first drug globally approved for IgA nephropathy treatment by multiple regulatory agencies, including NMPA, FDA, EMA, and MHRA, establishing its clinical significance [1][2] - Recent studies demonstrate Nefecon's efficacy in "etiological treatment, early intervention, and long-term treatment," showing significant clinical value in real-world applications [1][2] Group 1: Clinical Efficacy and Safety - A study titled "Beyond Nine Months" indicates that a 12-month treatment with Nefecon significantly reduces proteinuria and protects renal function compared to traditional therapies, with better safety profiles [3] - A 6-month retrospective cohort study shows that Nefecon significantly lowers proteinuria levels and improves renal function in Chinese patients, supporting its potential as a first-line treatment [4] - Real-world evidence indicates that Nefecon provides sustained renal protection, particularly in patients with acceptable renal function (eGFR ≥ 35 mL/min/1.73m), with gradual decreases in proteinuria and resolution of hematuria [8] Group 2: Treatment Guidelines and Recommendations - Nefecon has been included in the 2024 KDIGO clinical management guidelines for IgA nephropathy and IgA vasculitis, as well as the Chinese adult guidelines, marking it as the only drug recommended for etiological treatment [2] - The drug's inclusion in the national medical insurance drug list in November 2024 and subsequent approval for production expansion in August 2025 further solidifies its foundational role in IgA nephropathy treatment [2] Group 3: Special Populations and Case Studies - A case report on the use of Nefecon in patients with concurrent hepatitis B virus infection shows effective improvement in renal outcomes without viral reactivation, providing evidence for its use in this specific population [6] - The first real-world evidence of Nefecon's efficacy in pediatric patients with IgA nephropathy indicates significant reductions in proteinuria and hematuria, although caution is advised regarding its potential impact on the hypothalamic-pituitary-adrenal axis [7]

Core Insights - The 18th International Symposium on IgA Nephropathy (IIgANN) will be held in Prague, Czech Republic from September 17 to 20, 2025, where Nefecon® will present seven new real-world data studies showcasing its advancements in the field [1] - Nefecon® is the first IgA nephropathy treatment drug fully approved by multiple regulatory agencies including NMPA, FDA, EMA, and MHRA, highlighting its global significance [1][2] - Recent data from top hospitals in China demonstrate Nefecon®'s efficacy and safety in treating IgA nephropathy, emphasizing its clinical value in "etiological treatment, early intervention, and long-term treatment" [1][2] Group 1: Clinical Efficacy and Safety - Nefecon® has shown significant clinical value in treating IgA nephropathy, with real-world evidence validating its efficacy in reducing proteinuria and stabilizing kidney function [1][2] - A 12-month study indicated that Nefecon® significantly lowers proteinuria and protects kidney function compared to traditional treatments, with better safety profiles [3] - A 6-month retrospective cohort study confirmed that Nefecon® effectively reduces proteinuria levels and improves kidney function in Chinese patients, supporting its potential as a first-line treatment [4] Group 2: Treatment Guidelines and Recommendations - Nefecon® has been included in the 2024 KDIGO clinical management guidelines for IgA nephropathy and IgA vasculitis, as well as the Chinese adult guidelines, establishing its foundational role in treatment [2] - The drug emphasizes the need for both etiological and supportive treatments, marking a shift in traditional IgA nephropathy treatment approaches [2] Group 3: Special Cases and Observational Studies - Case reports indicate that Nefecon® can effectively treat IgA nephropathy patients co-infected with hepatitis B virus without causing viral reactivation, providing evidence for its use in this specific population [6] - Observational studies show that Nefecon® maintains kidney protection in patients with primary IgA nephropathy and renal insufficiency, demonstrating its potential in high-risk groups [8]

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (VERA) - **Industry**: Biotechnology, specifically focused on autoimmune kidney diseases - **Lead Product**: Atacicept, an immune modulator for B cell driven diseases, particularly IgA nephropathy Key Points and Arguments 1. **Product Development and Market Entry** - Vera Therapeutics plans to file for a Biologics License Application (BLA) in Q4 2025, with expectations to be on the market by mid-2026 [3][4][44] 2. **Unmet Medical Need** - There are approximately 160,000 patients in the U.S. with biopsy-proven IgA nephropathy, with at least half at high risk of disease progression [8][12] - Diagnosis is often delayed until around age 35, leading to urgent treatment needs as patients may require dialysis before age 50 if untreated [9][12] 3. **Clinical Trial Data** - Phase III trial showed a 46% reduction in proteinuria in the active group, significantly exceeding the FDA's 30% threshold for approval [22] - The GFR (glomerular filtration rate) data from the Phase II and interim Phase III trials indicate a potential to prevent the need for dialysis or transplant [25][27] 4. **Mechanism of Action** - Atacicept targets B cells, reducing the formation of immune complexes that lead to kidney inflammation and damage [16][17] - The drug is designed for self-administration via a low-volume auto-injector, enhancing patient convenience [43][57] 5. **Commercialization Strategy** - The company has been actively engaging with the nephrology community and has established a sales leadership team to prepare for the U.S. launch [50][51] - Early feedback indicates strong awareness and understanding of Atacicept among nephrologists [51] 6. **Regulatory Outlook** - The company is optimistic about receiving priority review from the FDA, based on the quality of their data and collaborative discussions with the agency [44][49] 7. **Pipeline and Future Studies** - Vera is exploring additional indications beyond IgA nephropathy, including membranous nephropathy and other autoimmune kidney diseases [59][60] - A study for monthly dosing of Atacicept is ongoing, with updates expected once the optimal dose is identified [55] Additional Important Information - **Patient Engagement** - Vera has been actively involved with patient advocacy groups, such as the IGAN Foundation, to better understand patient needs and improve treatment outcomes [53][54] - **Long-term Vision** - The company aims to transform the management of autoimmune kidney diseases and is focused on building a strong pipeline for future therapies [64] - **Acquisition** - Vera announced the acquisition of VT-109, a novel fusion protein, which is expected to complement their existing product offerings [56] This summary encapsulates the critical insights from the conference call, highlighting Vera Therapeutics' strategic direction, clinical advancements, and market potential in the biotechnology sector focused on kidney diseases.

Financial Data and Key Metrics Changes - The company reported its strongest quarter to date, with a 40% growth in demand uptake for Filspari since receiving full approval [4][8] - The revenue growth in Q2 outpaced patient start forms, indicating a lag in payer authorization updates following the full approval [10][11] - The company expects continued revenue growth due to strong patient compliance and persistence, with less than 10% of the addressable population currently reached [13] Business Line Data and Key Metrics Changes - The launch of Filspari for IgA nephropathy has seen consistent new patient starts, averaging around 700 since Q4 of the previous year [8] - The REMS modification has simplified monitoring for patients, which is expected to enhance patient access and compliance [5][20] - The company has an accepted sNDA for FSGS, with anticipation of approval by January next year [6] Market Data and Key Metrics Changes - Over 70% of patients are managed by community nephrologists, indicating a strong prescriber base for Filspari [27] - The competitive landscape includes Atarsentan, which has a more limited label, while Filspari has shown superior long-term data [29][41] - The draft QDIGO guidelines suggest earlier and more aggressive intervention for IgA nephropathy, which could increase the patient population eligible for Filspari [30][32] Company Strategy and Development Direction - The company aims to position Filspari as a foundational treatment for IgA nephropathy and FSGS, emphasizing its dual mechanism of action [28][35] - There is a focus on generating robust data for combination therapies, particularly with SGLT2 inhibitors and potential B cell therapies [45][47] - The company is committed to addressing the needs of the rare disease community, with plans to reinitiate Phase III trials for peg debatinase next year [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing engagement with the FDA regarding the approval process for FSGS, highlighting consistency in communication [48][54] - The company anticipates a powerful year ahead for the rare disease community, with hopes of providing new therapies for conditions like FSGS and HCU [64][66] - Management emphasized the importance of hope for families affected by rare diseases, indicating a strong commitment to advancing treatment options [64] Other Important Information - The company has made significant progress in modifying REMS requirements, which is expected to facilitate broader patient access [5][20] - The competitive positioning of Filspari is strengthened by its comprehensive clinical data and favorable payer access [41][42] Q&A Session Summary Question: What were the key accomplishments over the past year? - Management highlighted the successful launch and strong uptake of Filspari for IgA nephropathy as a major achievement [4] Question: How is the prescriber base evolving? - The majority of patients are managed by community nephrologists, with a strong competitive position in that segment [27] Question: What is the outlook for revenue growth? - Continued growth is expected due to high patient compliance and the potential to reach a larger addressable population [13] Question: How does the company plan to compete with new entrants? - The company believes in the superior profile of Filspari, emphasizing its dual mechanism of action and strong clinical data [29] Question: What are the timelines for potential REMS removal? - The company plans to engage with the FDA for a potential sNDA submission for full REMS removal after the PDUFA date for FSGS [25] Question: How does the company view combination therapies? - Management sees value in generating evidence for combination therapies and anticipates that physicians will likely use these in practice [47]