[Company Information](index=3&type=section&id=%E5%85%AC%E5%8F%B8%E8%B3%87%E6%96%99) This section provides essential corporate details, including governance, key personnel, and identifying information [Company Basic Information](index=3&type=section&id=%E5%85%AC%E5%8F%B8%E5%9F%BA%E6%9C%AC%E4%BF%A1%E6%81%AF) This section provides an overview of Everest Medicines' fundamental details, including governance, key personnel, and corporate identifiers - Joint Company Secretary Ms. Liu Xuxin resigned on **April 15, 2025**, with Mr. Yang Jinghang appointed concurrently[4](index=4&type=chunk) - The company's auditor is **Ernst & Young**[4](index=4&type=chunk) - The company's stock code is **1952**, and its website is **www.everestmedicines.com**[5](index=5&type=chunk) [Business Summary](index=5&type=section&id=%E6%A5%AD%E5%8B%99%E6%91%98%E8%A6%81) This section highlights the company's strategic advancements, significant sales growth, and pipeline progress across key therapeutic areas [Overall Business Overview](index=5&type=section&id=%E6%95%B4%E4%BD%93%E4%B8%9A%E5%8B%99%E6%A6%82%E8%A7%88) The company significantly grew sales revenue and advanced its innovative pipeline by deepening its "dual-driver" strategy and strengthening its Asian market presence - The company deepened its **"dual-driver" strategy**, achieving significant sales revenue growth and smooth progress in its innovative product pipeline[6](index=6&type=chunk) - Three commercialized products cover kidney, infectious, and autoimmune diseases, with estimated combined peak sales revenue exceeding **RMB 10 billion**[6](index=6&type=chunk) - Nefecon® is included in the **NRDL** and received **full NMPA approval**, leading to rapid sales growth[6](index=6&type=chunk) [Renal Pipeline](index=5&type=section&id=%E8%85%8E%E7%97%85%E7%AE%A1%E7%B7%9A) Nefecon®, a key product for IgA nephropathy, received full NMPA approval and NRDL inclusion, enhancing patient access, while EVER001 showed positive efficacy and safety in its Phase 1b/2a trial for primary membranous nephropathy - Nefecon® implemented new medical insurance pricing in **January 2025**, enhancing patient accessibility[8](index=8&type=chunk) - In **May 2025**, Nefecon® received **full NMPA approval**, removing proteinuria restrictions and becoming the first and only fully approved causal treatment for IgA nephropathy[9](index=9&type=chunk) - EVER001 (sibrotuzumab) Phase 1b/2a trial showed anti-PLA2R autoantibody reduction of approximately **93%** at 24 weeks, significant proteinuria decrease, stable renal function, and good safety[12](index=12&type=chunk) - Nefecon® production expansion approval will boost capacity to meet growing clinical demand in China and Asia more efficiently[13](index=13&type=chunk) [Infectious Disease Pipeline](index=8&type=section&id=%E6%84%9F%E6%9F%93%E6%80%A7%E7%96%BE%E7%97%85%E7%AE%A1%E7%B7%9A) The in vitro susceptibility testing standard for Eravacycline (Yijia®) was published, guiding clinical use, while EVER001's Phase 1b/2a trial reaffirmed positive efficacy and safety in primary membranous nephropathy - In **June 2025**, the "Eravacycline In Vitro Drug Susceptibility Testing Guidelines (2025)" were published, standardizing testing and interpretation[15](index=15&type=chunk) - EVER001 Phase 1b/2a interim data showed anti-PLA2R autoantibody reduction maintained above **93%**, proteinuria levels decreased to **76.7%** and **80.6%** at 36 weeks, and high immunological complete remission rates[16](index=16&type=chunk) [Autoimmune Disease Pipeline](index=9&type=section&id=%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB%E6%80%A7%E7%96%BE%E7%97%85%E7%AE%A1%E7%B7%9A) Etrasimod for ulcerative colitis demonstrated long-term safety and significant clinical benefits in global 4-year follow-up and Asian Phase III studies, gaining approval in Hong Kong, acceptance in Korea and Taiwan, and initiating local production - Etrasimod's global 4-year safety follow-up data confirmed good long-term safety and tolerability[19](index=19&type=chunk) - Etrasimod's Asian multi-center Phase III study showed significant clinical and endoscopic benefits, with consistent safety profiles[20](index=20&type=chunk) - Etrasimod Jiaxing factory production project launched, with an estimated annual capacity of **50 million tablets** upon operation[20](index=20&type=chunk) - In **April 2025**, Etrasimod received formal marketing approval from the Hong Kong Department of Health, China[20](index=20&type=chunk) - Etrasimod was strongly recommended in the **"2025 ACG Clinical Guidelines: Adult Ulcerative Colitis"** for moderate to severe active UC induction and maintenance[20](index=20&type=chunk) [mRNA Technology Platform](index=10&type=section&id=mRNA%E6%8A%80%E8%A1%93%E5%B9%B3%E5%8F%B0) The company established a leading AI+mRNA platform, advancing mRNA therapeutic cancer vaccines and self-generating CAR-T projects, with EVM16 in clinical trials, EVM14 gaining US FDA IND approval and China NMPA acceptance, and the CAR-T platform showing preclinical efficacy - The company developed an **AI-driven "Miaosuan" neoantigen algorithm**, advancing mRNA therapeutic cancer vaccines and self-generating CAR-T platforms[21](index=21&type=chunk) - Personalized therapeutic cancer vaccine **EVM16** completed first patient dosing and has dosed **nine patients** at Peking University Cancer Hospital[7](index=7&type=chunk)[23](index=23&type=chunk) - Universal therapeutic cancer vaccine **EVM14** IND application received **US FDA approval** and **China NMPA acceptance**, with clinical sample production completed[7](index=7&type=chunk)[23](index=23&type=chunk) - The self-generating CAR-T platform was validated in humanized mouse and non-human primate models, offering off-the-shelf, lymphodepletion-free, and dose-controllable advantages[21](index=21&type=chunk) [Corporate Development](index=11&type=section&id=%E5%85%AC%E5%8F%B8%E7%99%BC%E5%B1%95) The company removed its 'B' share designation, reflecting enhanced R&D and commercialization, successfully raised approximately HKD 1.55 billion for pipeline and commercialization acceleration, and became I-Mab's largest shareholder with a 16.1% stake, deepening its oncology immunotherapy strategy - In **April 2025**, the "B" designation was removed from Everest Medicines' stock short name, reflecting enhanced R&D, commercialization, and overall business fundamentals[28](index=28&type=chunk) - In **July 2025**, the company raised approximately **HKD 1.55 billion** through a placing of **22,561,000 shares**, with several times oversubscription[28](index=28&type=chunk) - In **August 2025**, the company strategically increased its stake in I-Mab to approximately **16.1%**, becoming its largest shareholder[28](index=28&type=chunk) [Financial Highlights](index=12&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) This section presents key financial performance indicators, including revenue growth, margin changes, and adjusted loss, based on IFRS and non-IFRS measures [IFRS Figures](index=12&type=section&id=%E5%9C%8B%E9%9A%9B%E8%B2%A1%E5%8B%99%E5%A0%B1%E5%91%8A%E6%BA%96%E5%89%87%E6%95%B8%E5%AD%97) For the six months ended June 30, 2025, revenue significantly increased by 48.0% to RMB 446.1 million, driven by Nefecon® and Yijia® growth, while gross margin decreased due to Nefecon®'s NRDL price adjustment, R&D expenses were optimized, and distribution and selling expenses rose with market expansion 2025 H1 Key Financial Data (IFRS) | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 446.1 | 301.5 | 48.0% | | Gross Margin | 67.1% | 76.6% | -9.5% | | Gross Margin (excl. intangible asset amortization) | 76.4% | 83.0% | -6.6% | | R&D Expenses | 195.2 | 253.2 | -22.9% | | G&A Expenses | 110.8 | 87.0 | 27.4% | | Distribution and Selling Expenses | 314.7 | 200.4 | 57.0% | - Revenue growth was primarily driven by the sustained growth of **Nefecon®** and **Yijia®** in commercialized markets[30](index=30&type=chunk) - Gross margin decreased primarily due to **Nefecon®'s NRDL price reduction** in mainland China and optimized product costs[32](index=32&type=chunk) [Non-IFRS Measures](index=13&type=section&id=%E9%9D%9E%E5%9C%8B%E9%9A%9B%E8%B2%A1%E5%8B%99%E5%A0%B1%E5%91%8A%E6%BA%96%E5%89%87%E8%A8%88%E9%87%8F) For the six months ended June 30, 2025, adjusted loss significantly narrowed to RMB 146.9 million, and loss for the period substantially decreased to RMB 249.8 million, driven by strong product sales, improved operational efficiency, and the one-time impact of mRNA COVID-19 vaccine-related intangible asset impairment loss in the prior year 2025 H1 Non-IFRS Key Financial Data | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | YoY Change (RMB million) | | :--- | :--- | :--- | :--- | | Adjusted Loss for the Period | (146.9) | (212.6) | 65.7 (narrowed) | | Loss for the Period | (249.8) | (632.4) | 382.6 (decreased) | - Total operating expenses as a percentage of sales decreased by **40.1 percentage points**, reflecting improved business and operational efficiency and focused resource allocation[36](index=36&type=chunk) - As of **June 30, 2025**, cash and cash equivalents and bank deposits totaled **RMB 1,585.9 million**[36](index=36&type=chunk) [Management Discussion and Analysis](index=14&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E5%8F%8A%E5%88%86%E6%9E%90) This section provides a comprehensive review of the company's operational performance, product pipeline, commercialization strategies, and financial results for the period [Overview](index=14&type=section&id=%E6%A6%82%E8%A7%88) As an integrated biopharmaceutical company, the company made significant progress in H1, including the removal of its 'B' share designation and a successful HKD 1.55 billion equity placement, bolstering capital reserves for its "dual-driver" strategy - The company is committed to creating value through a differentiated innovative medicine portfolio and building sustainable shareholder growth[41](index=41&type=chunk) - The **"dual-driver" strategy** focuses on organic pipeline growth via mRNA technology and synergistic effects through business expansion and in-licensing[41](index=41&type=chunk) - Nefecon®'s full-year sales are projected to reach **RMB 1.2 to 1.4 billion**, with total company full-year revenue expected to be **RMB 1.6 to 1.8 billion**[39](index=39&type=chunk)[40](index=40&type=chunk) [Product Pipeline](index=16&type=section&id=%E7%94%A2%E5%93%81%E7%AE%A1%E7%B7%9A) The company boasts a robust pipeline in renal, anti-infective, and autoimmune diseases, featuring first-in-class or best-in-class assets like approved Nefecon®, Yijia®, and Etrasimod, alongside clinical-stage candidates and advanced mRNA platform projects - The company's product pipeline includes first-in-class or best-in-class assets across renal, anti-infective, and autoimmune disease areas[43](index=43&type=chunk) Key Product Pipeline and Development Status | Molecule (Therapy) | Partner | Commercial Rights | Indication | R&D Progress | | :--- | :--- | :--- | :--- | :--- | | NEFECON® | Greater China, Singapore, South Korea | IgA Nephropathy | Approved in Mainland China, Macau, Hong Kong, Taiwan, South Korea, and Singapore | | Yijia® (Eravacycline) | Greater China, South Korea, Southeast Asia | Complicated Intra-abdominal Infections | Approved in Mainland China, Hong Kong, Taiwan, and Singapore | | Etrasimod | Greater China, South Korea, Singapore | Ulcerative Colitis | Approved in Macau, Hong Kong, and Singapore | | Cefepime-Taniborbactam | Greater China, South Korea, Southeast Asia | Complicated Urinary Tract Infections | Priority Review in Mainland China | | Zetomipzomib | Greater China, South Korea, Southeast Asia | Autoimmune Hepatitis | Phase 2a | | EVER001 (XNW1011) | Global | Membranous Nephropathy | Phase 1b/2a | | Personalized Cancer Vaccine | In-house R&D | Global | Oncology | IIT initiated | | Tumor-Associated Antigen Vaccine | In-house R&D | Global | Oncology | US IND approved | [Business Review](index=17&type=section&id=%E6%A5%AD%E5%8B%99%E5%9B%9E%E9%A1%A7) This section reviews pipeline and commercialization progress, highlighting Nefecon®'s full approval across Asia, Etrasimod's Hong Kong approval and regulatory submissions, positive EVER001 Phase 1b/2a data, and significant advancements in proprietary mRNA cancer vaccines EVM16 and EVM14, with EVM14 achieving dual US and China filings - Nefecon® achieved **full approval** across all authorized regions, solidifying its cornerstone position as a first-line treatment for IgA nephropathy in Asia[46](index=46&type=chunk) - Etrasimod received new drug marketing approval in **Hong Kong SAR**, with applications accepted in South Korea and Taiwan, and **NMPA approval in mainland China expected in H1 2026**[46](index=46&type=chunk) - EVER001 Phase 1b/2a trial for primary membranous nephropathy showed positive data, with anti-PLA2R antibody levels decreasing by nearly **100%** and proteinuria levels by approximately **80%**[47](index=47&type=chunk) - Personalized mRNA cancer vaccine **EVM16 IIT** completed dosing for **9 patients**, with preliminary data expected in H2 this year[48](index=48&type=chunk) - Universal TAA mRNA vaccine candidate **EVM14** received **US FDA IND approval** and **China NMPA acceptance**, achieving dual US and China filings[48](index=48&type=chunk) [Pipeline Outlook](index=17&type=section&id=%E7%AE%A1%E7%B7%9A%E5%B1%95%E6%9C%9B) Nefecon® achieved full approval across Asia, solidifying its IgA nephropathy treatment status, Etrasimod gained Hong Kong approval and is under review in Korea and Taiwan, with mainland China approval expected in H1 2026, EVER001 showed positive Phase 1b/2a data, and mRNA cancer vaccines EVM16 and EVM14, along with self-generating CAR-T projects, made significant progress - Nefecon® achieved **full approval** across all authorized regions, solidifying its cornerstone position as a first-line treatment for IgA nephropathy in Asia, and promoting treatment standardization[46](index=46&type=chunk) - Etrasimod received new drug marketing approval in **Hong Kong SAR**, with applications accepted in South Korea and Taiwan, and **NMPA approval in mainland China expected in H1 2026**[46](index=46&type=chunk) - EVER001 Phase 1b/2a trial for primary membranous nephropathy showed positive data, with anti-PLA2R antibody levels decreasing by nearly **100%** and proteinuria levels by approximately **80%**[47](index=47&type=chunk) - Personalized mRNA cancer vaccine **EVM16 IIT** completed dosing for **9 patients**, with preliminary data expected in H2 this year[48](index=48&type=chunk) - Universal TAA mRNA vaccine **EVM14** received **US FDA IND approval** and **China NMPA acceptance**, with US clinical studies planned for **H2 2025**[48](index=48&type=chunk) [Commercialization](index=18&type=section&id=%E5%95%86%E6%A5%AD%E5%8C%96) In H1 2025, Nefecon® and Yijia® generated RMB 446 million in sales revenue, with Nefecon® experiencing rapid growth due to NRDL inclusion and expanded hospital coverage, Yijia® showing steady growth with increased hospital penetration, and Etrasimod initiating early use in Guangdong and local production - In **H1 2025**, **Nefecon®** and **Yijia®** generated **RMB 446 million** in sales revenue[50](index=50&type=chunk) - Nefecon®'s inclusion in the **NRDL** on **January 1, 2025**, led to rapid H1 sales growth and over **20,000 new patients**[50](index=50&type=chunk) - Nefecon® was recommended as the preferred causal treatment in the **"Chinese Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Pre-review Version)"**[51](index=51&type=chunk) - Yijia®'s penetration increased in approximately **300 core hospitals**, showing steady sales growth, with its China breakpoint approved by CDE and updated in the package insert[53](index=53&type=chunk) - Etrasimod is in early use in **9 medical institutions** in Guangdong via the "Hong Kong and Macao Medicine and Medical Device Connect" policy, and the Jiaxing factory launched localized production with an estimated annual capacity of **5 million bottles**[56](index=56&type=chunk) [Commercialization Outlook](index=21&type=section&id=%E5%95%86%E6%A5%AD%E5%8C%96%E5%B1%95%E6%9C%9B) In H2 2025, the company will accelerate commercialization and expand access to innovative therapies, with Nefecon® fully integrated into medical insurance and projected for RMB 1.2-1.4 billion in annual sales, Yijia® deepening hospital penetration, and Etrasimod advancing mainland China launch preparations - Nefecon® will achieve full medical insurance coverage in H2 and is expected to be included in the **2025 KDIGO IgA Nephropathy Guideline** and China's first IgA nephropathy clinical guideline[57](index=57&type=chunk) - Nefecon®'s production capacity expansion approval paves the way for significant H2 2025 sales growth, with full-year sales projected at **RMB 1.2 to 1.4 billion**[58](index=58&type=chunk) - Yijia® will continue deep penetration in core hospitals, targeting high-potential institutions and optimizing its CSO cooperation model[58](index=58&type=chunk) - Combined full-year revenue for **Nefecon®** and **Yijia®** is projected to reach **RMB 1.6 to 1.8 billion** in 2025[58](index=58&type=chunk) - Etrasimod's mainland China launch preparations are advancing, setting the stage for rapid market entry post-NMPA approval in **H1 2026**[59](index=59&type=chunk) [In-house R&D](index=21&type=section&id=%E8%87%AA%E4%B8%BB%E7%A0%94%E7%99%BC) H1 2025 marked a critical execution period for the company's "dual-driver" strategy and mRNA platform, with personalized mRNA cancer vaccine EVM16 completing dosing for 9 patients showing good immunogenicity, universal TAA mRNA cancer vaccine EVM14 achieving dual US and China filings and releasing GMP clinical samples, and the mRNA self-generating CAR-T platform yielding multiple preclinical validation results - The company successfully hosted the **"2025 Everest Medicines mRNA Innovation Technology Platform R&D Day,"** showcasing advancements in its proprietary AI-driven mRNA technology platform[60](index=60&type=chunk) - Personalized mRNA therapeutic cancer vaccine **EVM16 IIT** completed dosing for **9 patients**, showing good immunogenicity by eliciting specific T-cell responses even at low starting doses[62](index=62&type=chunk) - Universal TAA mRNA cancer vaccine **EVM14** achieved dual US and China filings and released the first batch of **GMP clinical trial samples**, validating the company's full-chain mRNA platform[63](index=63&type=chunk) - The mRNA self-generating CAR-T platform achieved multiple preclinical validation results, demonstrating efficacy in humanized mouse and non-human primate models, potentially revolutionizing traditional CAR-T therapies[64](index=64&type=chunk) - In **H2 2025**, personalized cancer vaccine **EVM16** is expected to complete Phase Ia enrollment, **EVM14** will start US dosing and may receive China IND approval, and the self-generating CAR-T platform is expected to identify clinical candidates[65](index=65&type=chunk) [Business Development](index=23&type=section&id=%E6%A5%AD%E5%8B%99%E6%8B%93%E5%B1%95) The 2025 business development strategy focuses on high clinical value, differentiated first-in-class or best-in-class assets in renal, autoimmune, and anti-infective diseases, seeking in-licensing opportunities for commercial or near-commercial assets, and global partnerships for early-stage assets like EVER001 and mRNA platform projects, while strategically increasing I-Mab equity to become its largest shareholder, deepening oncology immunotherapy - Business development focuses on high clinical value, differentiated first-in-class or best-in-class assets, prioritizing renal, autoimmune, and anti-infective diseases[66](index=66&type=chunk) - The company will seek in-licensed assets at commercial or near-commercial stages and actively pursue international collaboration for early-stage global assets[66](index=66&type=chunk)[67](index=67&type=chunk) - One-year follow-up data for primary membranous nephropathy patients in the **EVER001 (sibrotuzumab) Ib/IIa clinical trial** is expected in **September**[67](index=67&type=chunk) - mRNA-based therapeutic cancer vaccine projects **EVM16** and **EVM14** will yield key preliminary human data in **H2 this year** and **H1 next year**, respectively, supporting potential global collaborations[67](index=67&type=chunk) - The company strategically increased its stake in I-Mab to approximately **16.1%**, becoming its largest shareholder and advancing its global next-generation oncology immunotherapy pipeline[68](index=68&type=chunk) [Financial Review](index=24&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) For the six months ended

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年8月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 雲頂新耀有限公司 | | | | 呈交日期: | 2025年9月4日 | | | I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01952 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | ...

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]

Core Viewpoint - The report from CMB International highlights that after resolving capacity constraints, the sales of Nanfukang have rapidly increased in August, exceeding both the firm's and market expectations for the first eight months of 2025, leading to an upward revision of sales guidance by management, reflecting strong confidence in clinical data and commercialization capabilities [1] Group 1: Company Performance - The company reported a 48% year-on-year revenue growth in the first half of the year, reaching 446 million RMB [1] - Sales of Yijia and Nanfukang grew by 6% and 81% respectively, amounting to 143 million RMB and 303 million RMB [1] - Based on the strong sales performance of Nanfukang, the firm has raised its revenue forecasts for 2026 and 2027 by 16% to 18% [1] Group 2: Market Outlook - CMB International is optimistic about the company's long-term growth driven by the commercialization of its major products and self-research platform [1] - The target price for the company has been raised from 72.5 HKD to 84 HKD, corresponding to a peak revenue multiple of 2.1 times [1] - The firm notes that the second half of this year through 2026 will be rich in catalysts, including the approval of Aiqumou in China, commercialization, and negotiations with medical insurance, as well as business development opportunities for self-research pipelines [1]

中金发表研报指，云顶新耀上半年业绩符合该行预期，收入按年增长48%至4.46亿元。其中耐赋康贡献 收入3.03亿元，按年增长81%。由于终端需求旺盛，中金上调耐赋康今明两年销售预期，调整2026年盈 利预测，由1200万元修订至1.19亿元。该行维持对其"跑赢行业"评级，由于市场开始将公司在研管线出 海预期打入估值，上调目标价10%至88港元。 ...

Group 1 - The core viewpoint of the report is that due to strong demand for Naisukan, the sales forecast for 2025 and 2026 has been raised, with the 2026 profit forecast adjusted from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Naisukan contributing 3.03 billion, a growth of 81% [2] - The company has set a sales target for Naisukan of 12-14 billion for 2025, which is over 200% growth year-on-year, and 24-26 billion for 2026, approximately 100% growth year-on-year [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas development, with EVER001 being a new generation covalent reversible BTK inhibitor showing positive results in clinical trials [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company's In vivo CAR-T platform has completed several studies in non-human primates, with plans to initiate clinical trials by the end of the year [3]

Group 1 - The core viewpoint is that due to strong demand for Nanfukang, the sales forecast for 2025 and 2026 has been raised, with a significant adjustment in the 2026 profit forecast from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Nanfukang contributing 3.03 billion, a growth of 81% [2] - Nanfukang's sales target for 2025 is set at 12-14 billion, indicating a year-on-year growth of over 200%, while the target for 2026 is 24-26 billion, reflecting a growth of approximately 100% [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas expansion, with positive results from ongoing clinical trials for kidney disease treatments [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company plans to initiate clinical trials for its In vivo CAR-T platform by the end of the year after completing several studies on non-human primates [3]

Core Viewpoint - The report from CMB International indicates that Genting New Year achieved a 48% year-on-year revenue growth to 446 million yuan in the first half of the year, driven by significant sales increases in its key products [1] Group 1: Financial Performance - Genting New Year’s revenue reached 446 million yuan, marking a 48% increase year-on-year [1] - Sales of Yijia and Naifukang grew by 6% and 81% respectively, amounting to 143 million yuan and 303 million yuan [1] - Following the resolution of capacity constraints, Naifukang saw rapid sales growth in August, exceeding both the bank's and market expectations for the first eight months of 2025 [1] Group 2: Management Outlook - The management has raised its sales guidance, reflecting strong confidence in the clinical data and commercialization capabilities of its products [1] - The company is expected to benefit from a dual-driven growth model through the commercialization of its major products and self-research platform [1] Group 3: Future Catalysts and Valuation - The bank has raised its target price from 72.5 HKD to 84 HKD, corresponding to a 2.1 times peak revenue sales multiple, maintaining a "Buy" rating [1] - The second half of this year through 2026 is anticipated to have rich catalysts, including the approval of Aiqumou in China, commercialization, and negotiations with health insurance, as well as business development opportunities for self-research pipelines [1] - Based on the strong sales performance of Naifukang, the bank has increased its revenue forecasts for 2026 to 2027 by 16% to 18%, along with a more optimistic outlook on operating expense ratios [1]

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]