Core Insights - The innovative drug Etrasimod (VELSIPITY) developed by the company for treating moderate to severe active ulcerative colitis (UC) has shown promising results in the ENLIGHT UC Phase III clinical study, published in The Lancet Gastroenterology & Hepatology [1][2] - The study demonstrated a mucosal healing rate of 51.9% and a complete normalization rate of 45.5% after 52 weeks of treatment, significantly higher than the current 24% rate among patients achieving mucosal healing [1][3] - Etrasimod is anticipated to reach peak sales of 5 billion yuan, positioning it as a key product alongside the company's existing offerings in the autoimmune disease sector [1][5] Study Details - The ENLIGHT UC study was a multicenter, randomized, double-blind, placebo-controlled trial involving 340 patients who had previously failed or were intolerant to standard treatments for UC [2][3] - Results indicated statistical significance and clinical relevance across all primary and secondary efficacy endpoints during both the 12-week induction and 40-week maintenance phases [2] Clinical and Market Implications - The increasing prevalence of UC in Asia, with an estimated 800,000 patients in China by 2024 projected to rise to nearly 1.5 million by 2031, highlights the urgent clinical need for effective treatments [3][4] - Etrasimod's mechanism as a high-selectivity oral S1P receptor modulator aligns with the core treatment needs for UC, offering advantages such as rapid onset of action and deep mucosal healing [4][5] - The drug has been recognized in clinical guidelines, being recommended as a first-line treatment for UC by the American Gastroenterological Association and the American College of Gastroenterology [4][5] Commercialization Progress - Etrasimod has received approvals in regions such as Macau, Singapore, and Hong Kong, with new drug applications (NDA) accepted in Taiwan and South Korea [5] - The company has initiated local production in Zhejiang, aiming for an annual capacity of 50 million tablets to ensure supply [5] - The NDA for Etrasimod in mainland China is expected to be approved by mid-2026, which will benefit domestic patients [5]

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].

Group 1: Strategy and Market Outlook - The report suggests a strong allocation towards precious metals, particularly gold, and recommends overweighting Hong Kong stocks benefiting from potential Federal Reserve rate cuts, while maintaining positions in A-shares with a balanced focus on resources and technology growth [1][10] - The report highlights the acceleration of de-dollarization and challenges to the independence of the Federal Reserve, which may lead to increased demand for gold as a safe asset [8][9] Group 2: Motorcycle Industry Insights - The domestic large-displacement motorcycle penetration rate is continuously increasing, with significant growth potential for Chinese motorcycle manufacturers in the global market, particularly in large-displacement segments [2][12] - The report indicates that from 2020 to 2024, the sales of large-displacement motorcycles in China are expected to grow from approximately 140,000 units to 400,000 units, with a CAGR of 30% [13] - Exports are becoming a crucial growth driver for Chinese motorcycle manufacturers, with the export volume of motorcycles expected to increase significantly, particularly in the large-displacement category [14][15] Group 3: Company-Specific Analysis - Tengya Precision (301125.SZ) is expected to achieve a net profit of 44 million, 149 million, and 231 million yuan from 2025 to 2027, with corresponding PE ratios of 64.2, 18.9, and 12.2, indicating strong growth potential [5][22] - Zhongke Shuguang (603019.SH) is projected to have a net profit of 2.712 billion, 3.355 billion, and 3.762 billion yuan from 2025 to 2027, with a year-on-year growth of 41.9%, 23.7%, and 12.2% respectively [6][24] - The report emphasizes the robust growth of the AI and smart inspection business for Zeyu Intelligent (301179.SZ), with expected net profits of 222 million, 266 million, and 322 million yuan from 2025 to 2027 [37][39] Group 4: Investment Recommendations - Key recommendations include focusing on leading motorcycle manufacturers such as Chunfeng Power, Longxin General, and Qianjiang Motorcycle, which are expected to benefit from the growing global demand for large-displacement motorcycles [3][16] - The report suggests maintaining a "buy" rating for Tengya Precision, Zhongke Shuguang, and Zeyu Intelligent based on their growth prospects and market positioning [22][24][39]

Core Viewpoint - The company has demonstrated strong sales growth for its product, Naisfukang, following capacity expansion, leading to an upward revision of sales guidance and reflecting confidence in clinical data and commercialization capabilities [1][2] Group 1: Sales Performance - In the first half of 2025, the company's revenue increased by 48% year-on-year to 446 million RMB, with Naisfukang sales growing by 81% to 303 million RMB [1] - After capacity constraints were resolved, Naisfukang's sales surged to 522 million RMB in August, contributing to a total sales figure of 825 million RMB from January to August [1] - The management has raised the annual sales target for Naisfukang to 1.2-1.4 billion RMB, with total product sales expected to reach 1.6-1.8 billion RMB [1] Group 2: Financial Outlook - The company expects to achieve operational breakeven in the second half of 2025, earlier than previously anticipated [1] - The net loss for the first half of 2025 narrowed significantly by 61% to 250 million RMB, attributed to strong sales performance and stable SG&A expense ratios [1] Group 3: Product Pipeline and Future Prospects - The company is set to commercialize its third product, Aicuo Mod, which is anticipated to be approved in the first half of 2026 for ulcerative colitis, with a projected peak sales of 5 billion RMB [2] - The self-developed pipeline includes EVER001, targeting autoimmune kidney diseases, with global sales peak expected to exceed 10 billion RMB [2] - The company has revised its revenue forecasts for 2026-2027 upwards by 16-18%, reflecting optimism in operational expense ratios and potential catalysts in the pipeline [2] Group 4: Valuation and Investment Recommendation - The target price has been raised to 84 HKD from 72.5 HKD, corresponding to a 2.1 times revenue peak sales multiple [2] - The current valuation remains attractive, with multiple catalysts expected in the second half of 2025 and 2026, including product approvals and commercialization efforts [2]

Investment Rating - The report assigns a "Buy" rating to the company, indicating an expectation of total returns exceeding the relevant industry over the next 12 months [3][12]. Core Insights - The company has experienced rapid sales growth following the resolution of capacity constraints, with sales for the first eight months of 2025 exceeding both the report's and market expectations. The management has raised sales guidance, reflecting strong confidence in clinical data and commercialization capabilities [2][7]. - The target price has been raised to HKD 84.00, representing a potential upside of 32.2% from the current price of HKD 63.55 [1][12]. Financial Performance Summary - Revenue for 2025 is projected at RMB 1,611 million, with a significant increase to RMB 2,951 million in 2026 and RMB 4,408 million in 2027, reflecting a growth trajectory [6][13]. - The company reported a net loss of RMB 160 million for 2025, with expectations of turning profitable by 2026 with a net profit of RMB 325 million [6][13]. - The gross profit margin is expected to stabilize around 70% in 2025, improving to 73% in 2026 and 74.5% in 2027 [6][13]. Sales and Market Dynamics - The company’s flagship product, Nanfukang, has seen sales growth of 81% year-on-year, with total sales expected to reach RMB 12-14 billion for the year, and potentially doubling to RMB 24-26 billion in 2026 [7][8]. - The company is also advancing its pipeline with promising clinical data, particularly for its third commercialized product, which is anticipated to achieve peak sales of RMB 5 billion [7][8]. Valuation and Future Outlook - The report utilizes a DCF model to arrive at a target price of HKD 84.00, based on optimistic revenue forecasts and improved operating expense ratios [8][12]. - The company is expected to achieve operational breakeven in the second half of 2025, earlier than previously anticipated [7][8].

Summary of Key Points from the Conference Call Company Overview - **Company**: 云顶新耀 (Genting New Horizon) - **Industry**: Biotechnology and Pharmaceuticals Financial Performance - **2025 Revenue Forecast**: Expected total revenue of 16-18 billion RMB, with耐赋康 (Nai Fu Kang) sales projected at 12-14 billion RMB, potentially becoming the first non-oncology drug to exceed 1 billion RMB in sales in its first year post-medical insurance inclusion [1][4] - **2025 H1 Revenue**: Achieved 4.46 billion RMB, a 48% year-on-year increase [6] - **Cash Position**: Cash balance of 1.6 billion RMB as of June 30, 2025, following a successful 1.6 billion HKD equity financing [6] Product Performance - **耐赋康 (Nai Fu Kang)**: - Strong market performance with 8.2 billion RMB in revenue from January to August 2025, including 5.2 billion RMB in August alone [1][8] - Expected sales of 12-14 billion RMB in 2025 and 24-26 billion RMB in 2026, driven by medical insurance coverage and expanding patient demand [10] - Currently included in the national medical insurance directory across 29 provinces [2] - **艾曲莫德 (Ai Qu Mo De)**: - Considered a second major product targeting ulcerative colitis, with peak sales expected to reach 5 billion RMB [15] - Anticipated approval in H1 2026, showcasing strong mucosal healing capabilities [15][18] Research and Development - **MRNA Platforms**: - Progress in MRNA self-generating CAR-T platform, with clinical development expected to start by the end of 2025 [5] - Multiple products in the MRNA tumor vaccine pipeline, including EVM16, TAAEV M14 (approved by the US IND), and EVN15 [5][24] - **Clinical Trials**: - 西布替尼 (Xibu Tini) shows promising results in primary membranous nephropathy, with plans for registration clinical trials in 2026 [20][22] - gdig test reagent for IgA nephropathy is under development, expected to enhance patient compliance and diagnosis accuracy [13] Market Strategy - **Commercialization Model**: - Aiming to expand hospital coverage to 1,000 hospitals, targeting 80% of market potential [11] - Plans for international market entry, including regions like South Korea and Taiwan [11] - **Insurance Negotiations**: - Preparing for favorable conditions in upcoming medical insurance negotiations to support product launches [3][12] Competitive Landscape - **Market Position**: -耐赋康 is the first and only fully approved IgA nephropathy treatment included in the national medical insurance directory, with a two-year exclusivity period [10][50] -艾曲莫德 is positioned to address unmet needs in ulcerative colitis, with significant market potential due to the high prevalence of the disease [15][40] Future Outlook - **Sales Projections**: - Confident in achieving 12-14 billion RMB in sales for 2025, with expectations to double in 2026 [12][34] - **R&D Investment**: - Continued investment in high-barrier platforms, with a focus on autoimmune diseases and CRMI platforms [44] - **Strategic Partnerships**: - Actively seeking collaborations to enhance product development and market reach, particularly in the MRNA and CAR-T sectors [46][48] Conclusion - **Growth Strategy**: - The company is positioned for significant growth through its innovative product pipeline, strong financial health, and strategic market expansion efforts, aiming to become a leading player in the global biopharmaceutical industry [51]

Core Viewpoint - CloudTop New Horizon (01952) saw a significant stock increase of over 5%, closing at 73.35 HKD with a trading volume of 499 million HKD, following the announcement of its core product, Aicromod, being included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis [1] Group 1: Product Development and Recognition - Aicromod has been strongly recommended for the induction and maintenance treatment of moderate to severe active Ulcerative Colitis (UC) patients in the newly released guidelines [1] - The product was previously included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for Ulcerative Colitis, highlighting its clinical value and potential to fill treatment gaps [1] Group 2: Strategic Investments - CloudTop New Horizon announced a strategic investment of 30.9 million USD in Tianjing Bio, increasing its ownership stake to 16.1%, making it the largest shareholder [1] - According to CMB International, this strategic investment allows the company to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical transformation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1]

Core Viewpoint - CloudTop New Horizon (01952) saw a significant stock increase of over 5%, closing at HKD 73.35 with a trading volume of HKD 499 million, following the announcement of its core product, Aikumo, being included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis [1] Group 1: Product Development and Recognition - Aikumo has been strongly recommended for the induction and maintenance treatment of moderate to severe active ulcerative colitis (UC) patients in the newly released guidelines [1] - The product was previously included in the 2024 AGA Clinical Practice Guidelines, marking it as a first-line treatment for ulcerative colitis [1] - The dual endorsement from two major international guidelines underscores Aikumo's clinical value and its potential to fill a treatment gap in ulcerative colitis [1] Group 2: Strategic Investment - CloudTop New Horizon announced a strategic investment of USD 30.9 million in Tianjing Bio, increasing its ownership stake to 16.1%, making it the largest shareholder [1] - According to CMB International, this strategic investment allows the company to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1]