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 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]

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]

Group 1 - The company reported a revenue of RMB 446 million for H1 2025, representing a 48% year-on-year increase, with a significant reduction in non-IFRS losses by 31% [1] - The gross margin, excluding non-cash items, was 76.4%, and the cash reserves reached RMB 1.6 billion by the end of June 2025 [1] - Sales of the drug NAI Fukan reached RMB 303 million in H1 2025, an 81% increase year-on-year, with expectations for annual sales to reach RMB 1.2-1.4 billion [1] Group 2 - The drug NAI Fukan is the first targeted therapy for IgA nephropathy, successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [1] - The company anticipates that NAI Fukan will be included in the KDIGO 2025 guidelines and the first IgA nephropathy guidelines in China [1] - Sales of the drug Yijia reached RMB 143 million in H1 2025, a 6% increase year-on-year, with a 37% increase in pure sales from core hospitals [1] Group 3 - The drug EVER001 (Hibutinin) is positioned as a potential best-in-class product, with positive results from ongoing clinical trials presented at the ERA 2025 conference [2] - The drug Aiqumide has completed a significant clinical study in Asia for moderate to severe ulcerative colitis and is expected to receive approval in mainland China by H1 2026 [2] - The company is leveraging its proprietary mRNA technology platform to develop globally competitive products, including personalized cancer vaccines [3] Group 4 - The mRNA-based cancer vaccine EVM16 completed its first patient dosing in March 2025, while EVM14 received FDA IND approval, marking a significant milestone for the company [3] - The company expects to complete preclinical milestones for its CAR-T project based on the mRNA technology platform in the second half of 2025 [3] - The revenue forecast for the company has been raised, with projected total revenues of RMB 1.738 billion, RMB 2.869 billion, and RMB 3.351 billion for 2025-2027 [3]

Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, driven by the inclusion of its product in the national medical insurance directory and deepening market penetration, indicating strong growth potential in the healthcare sector [1][2]. Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of 446 million RMB, representing a year-on-year increase of 48% [1]. - The non-deductible net profit attributable to the parent company was -250 million RMB, showing a year-on-year reduction in losses of 59.44% [1]. Group 2: Kidney Disease Sector - The product "耐赋康" has been included in the national medical insurance directory since 2024, covering 29 provinces, with sales reaching 303 million RMB in the first half of 2025, an increase of 81% year-on-year [1]. - The product's sales in August alone reached 520 million RMB, with an expected annual revenue of 1.2 to 1.4 billion RMB, leading to anticipated operational profitability in the second half of 2025 [1]. - The clinical trial data for EVER001, a treatment for membranous nephropathy, shows significant reductions in anti-PLA2R antibodies and proteinuria, with a clinical remission rate exceeding 90% [1]. Group 3: Infection Sector - The product "依嘉" achieved revenue of 143 million RMB in the first half of 2025, reflecting a year-on-year growth of 37% [2]. - The company plans to initiate local production and expects to start medical insurance negotiations in 2026 [2]. - Combined revenue from "耐赋康" and "依嘉" is projected to be between 1.6 to 1.8 billion RMB in 2025 [2]. Group 4: Autoimmune Sector - "艾曲莫德" is positioned to become a key product for ulcerative colitis, having been included in the 2025 ACG clinical guidelines as a strongly recommended first-line treatment [2]. - The product has received approvals in multiple regions, with expectations for domestic approval in the first half of 2026 [2]. Group 5: Strategic Developments - The company has launched an AI+mRNA platform and achieved its first clinical results, with the personalized tumor vaccine EVM16 completing its first administration [3]. - The self-generating CAR-T project EVM18 is set to begin clinical trials by the end of 2025 after successful preclinical studies [3]. - The company invested 30.9 million USD in I-Mab, becoming its largest shareholder, which is a strategic move in the field of tumor immunotherapy [3]. Group 6: Revenue Forecast - The company forecasts revenues of 1.806 billion RMB, 3.396 billion RMB, and 5.380 billion RMB for 2025, 2026, and 2027, respectively, with growth rates of 155.63%, 87.98%, and 58.43% [3]. - The net profit attributable to the parent company is projected to be -486 million RMB, 146 million RMB, and 744 million RMB for the same years, with growth rates of -1.38%, 0.42%, and 2.12% [3].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 73.6 per share, up from the previous target of HKD 59.15 [7]. Core Insights - The company has significantly raised its guidance for the drug Naisukan, expecting sales to reach RMB 12-14 billion in 2025, with continued high growth projected for 2026 at RMB 24-26 billion [2]. - The company reported a revenue of RMB 4.46 billion for the first half of 2025, marking a 48% year-on-year increase, with a notable reduction in non-IFRS losses by 31% [1]. - The company is focusing on innovative products with differentiated competitive advantages, particularly in the fields of anti-infection and kidney disease treatments [7]. Summary by Sections Naisukan Performance - Naisukan achieved sales revenue of RMB 3.03 billion in H1 2025, representing an 81% year-on-year growth, with August sales reaching RMB 5.20 billion [2]. - The drug was successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [2]. Other Drug Developments - The drug Yijia generated revenue of RMB 1.43 billion in H1 2025, a 6% increase, with a 37% growth in direct sales to hospitals [3]. - EVER001 (Hibutinib) is showing promising clinical trial results, positioning it as a potential best-in-class product for broad-spectrum autoimmune kidney diseases [4]. Clinical Trials and Approvals - The drug Aiqumide has completed a significant clinical study in Asia and is expected to receive approval in mainland China by H1 2026 [5]. - The company is advancing its mRNA technology platform, with the EVM16 personalized cancer vaccine having completed its first patient dosing and EVM14 receiving FDA IND approval [6]. Financial Projections - The company has revised its revenue forecasts for 2025-2027 to RMB 17.38 billion, RMB 28.69 billion, and RMB 33.51 billion respectively, reflecting the strong performance of Naisukan and the anticipated approval of Aiqumide [7].

Core Points - CloudTop New Horizon (01952) announced that on September 2, 2025, employees (excluding directors) exercised stock options under the post-IPO employee stock option plan, resulting in the issuance of 1,257 shares [1] - On September 5, 2025, the company issued 2.6061 million shares according to the pre-IPO employee stock option plan adopted on December 25, 2018 (revised and restructured on February 17, 2020) and the post-IPO share award plan adopted on September 21, 2020 [1]