[Table_scodeMsg1] 港股研究丨公司深度丨云顶新耀（01952.HK） [Table_Title] 云顶新耀深度系列报告（一）：自免肾病龙头 Biopharma，耐赋康+维适平塑造双增长极 %% %% %% %% research.95579.com 1 丨证券研究报告丨 报告要点 [Table_Summary] 云顶新耀是一家专注于创新药和疫苗研发、制造及商业化的生物制药公司。近年来逐步形成了 License-in 引进大单品、自研高门槛管线的双轮驱动格局。作为系列报告的第一篇，本篇报告 将聚焦公司引进的肾病、自免领域的大单品（耐赋康、EVER001、艾曲莫德等）。具体来说， 耐赋康在 IgA 肾病领域临床证据全面，或将成为基石疗法之一；EVER001 有望填补原发性膜 性肾病对因治疗空白；艾曲莫德黏膜愈合优势明确，强势切入中重度 UC 小分子口服药市场。 整体来看，公司重磅品种放量趋势显著，远期空间巨大，将持续夯实公司增长基石。 彭英骐 刘长洪 请阅读最后评级说明和重要声明 2 / 46 %% %% %% %% 分析师及联系人 [Table_Author] SAC：S049052403000 ...

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 | | | 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12月3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 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 ...

Core Insights - The appointment of Sheng Feng as Vice President of Market Access and Commercial Operations at GSK China marks a significant leadership change within the pharmaceutical industry, indicating strategic planning behind the move [1][3] - GSK China has undergone multiple leadership adjustments in recent years, reflecting a shift towards localized and collaborative organizational restructuring [3] Leadership Changes - Sheng Feng will report directly to Yu Huiming, the General Manager of GSK China, and will be part of the China Leadership Team [1] - GSK China has seen a series of high-level appointments, including Yu Huiming's promotion to General Manager and the establishment of a Chief Operating Officer role [3] Performance Metrics - GSK reported total revenue of £8.547 billion (approximately $11.3 billion) for Q3 2025, with a year-on-year growth of 8% at constant exchange rates [4] - Specialty pharmaceuticals generated £3.4 billion in sales, marking a 16% increase, driven by oncology (+39%) and respiratory and immunology (+15%) segments [4] Strategic Direction - GSK China is transitioning from a product-driven approach to a system-driven model, aiming to enhance operational efficiency and market execution [3] - The company is focusing on integrating market access and commercial operations to streamline policy implementation and market execution [3] Company Evolution - Yunding New Drug has completed a significant governance transition, with founder Fu Wei stepping down as chairman, indicating a new phase in corporate governance [4][5] - The company is shifting its strategy from primarily "License-in" to a dual approach of "independent research and development + business development abroad," with several core pipelines entering late-stage clinical trials [5]

Core Viewpoint - Cloud-based innovative pharmaceutical company, CloudTop New Medicine (1952.HK), has initiated the first patient dosing of its universal on-demand tumor therapeutic vaccine EVM14 in a global multi-center Phase I clinical trial, marking a significant milestone in clinical development and showcasing the company's strong capabilities in global clinical development [1][2]. Group 1: EVM14 Development and Clinical Trials - EVM14 is an mRNA-based tumor therapeutic vaccine targeting five tumor-associated antigens (TAA) and is intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [2]. - The vaccine has received IND approval from both the U.S. FDA and China's NMPA, making it the first mRNA tumor therapeutic vaccine from CloudTop to achieve dual approval [2]. - The Phase I clinical trial design includes both EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibodies, focusing on safety, tolerability, and efficacy [3]. Group 2: Clinical Research and Efficacy - Preclinical studies have shown that EVM14 induces dose-dependent antigen-specific immune responses and significantly inhibits tumor growth in various mouse models, demonstrating its potential to reduce tumor recurrence [3]. - The preclinical research also indicates that EVM14 can enhance anti-tumor activity when used in combination with immune checkpoint inhibitors (ICI), supporting further exploration of combination therapies in clinical settings [3]. Group 3: Market Potential and Competitive Advantage - EVM14 offers advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad market potential [4]. - The global mRNA therapy market is projected to grow from $12.31 billion in 2025 to approximately $45.04 billion by 2034, with a compound annual growth rate (CAGR) of 15.5% from 2025 to 2034 [4]. - CloudTop has established a comprehensive mRNA technology platform, covering antigen design, sequence optimization, delivery systems, and large-scale production, positioning itself as a core competitor in the mRNA field [5].

Key Points - The top three companies with net inflows of southbound funds are Alibaba-W (09988) with 3.296 billion, XPeng Motors-W (09868) with 1.147 billion, and Xiaomi Group-W (01810) with 0.853 billion [1][2] - The top three companies with net outflows of southbound funds are Yingfu Fund (02800) with -0.559 billion, China Life (02628) with -0.427 billion, and China National Offshore Oil Corporation (00883) with -0.368 billion [1][2] - In terms of net inflow ratio, ICBC South China (03167) leads with 100.00%, followed by Xiaocai Garden (00999) with 74.08%, and Qingdao Bank (03866) with 67.42% [1][3] - The companies with the highest net outflow ratios include Q Tech (01478) at -58.31%, China National Heavy Duty Truck Group (03808) at -53.04%, and Nexperia (01316) at -43.99% [1][4] Net Inflow Rankings - Alibaba-W (09988) had a net inflow of 3.296 billion, representing a 20.59% increase in its closing price to 154.600 [2] - XPeng Motors-W (09868) saw a net inflow of 1.147 billion, with a 25.58% increase in its closing price to 85.950 [2] - Xiaomi Group-W (01810) experienced a net inflow of 0.853 billion, with a 9.75% increase in its closing price to 40.780 [2] Net Outflow Rankings - Yingfu Fund (02800) had a net outflow of -0.559 billion, with a -4.24% change in its closing price to 26.060 [2] - China Life (02628) experienced a net outflow of -0.427 billion, with a -23.81% change in its closing price to 26.140 [2] - China National Offshore Oil Corporation (00883) had a net outflow of -0.368 billion, with a -14.88% change in its closing price to 21.800 [2]

Core Insights - CloudTop New Medicine (01952.HK) has initiated the first patient dosing in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14, marking a significant milestone in the company's mRNA technology platform and its global clinical development efforts [1] Group 1: Product Development - EVM14 is developed based on CloudTop's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA), intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [1] - Approximately 96% of sq-NSCLC patients and 97% of HNSCC patients express at least one TAA gene, indicating a strong potential patient population for EVM14 [1] Group 2: Clinical Trial Details - The Phase I clinical trial design includes both EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibodies, with primary endpoints focusing on safety and tolerability, and secondary endpoints on efficacy [2] - The project is expected to complete the dose escalation for monotherapy by 2026, providing initial safety and tolerability data [2] - Clinical centers involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Shanghai Chest Hospital in China [2] Group 3: Preclinical Results - Preclinical trials demonstrated that EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in various mouse tumor models [2] - EVM14 also showed the ability to induce immune memory and effectively reduce tumor recurrence, supporting the exploration of combination therapy with immune checkpoint inhibitors (ICIs) [2] Group 4: Broader Pipeline - CloudTop is developing a range of tumor and other therapeutic mRNA drugs, leveraging its leading self-developed mRNA tumor therapeutic vaccine platform and autologous CAR-T platform, with full intellectual property rights and global rights for its pipeline [3] - In addition to EVM14, the pipeline includes autologous CAR-T project EVM18, personalized tumor therapeutic vaccine (PCV) EVM16, and on-demand immune modulation vaccine EVM15 [3]

每经AI快讯，云顶新耀(01952.HK)涨超5%，截至发稿，涨4.07%，报48.56港元，成交额1.58亿港元。 （文章来源：每日经济新闻） ...

Core Viewpoint - Cloud Peak New Medicine (01952) has seen a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Research Findings - NEFECON demonstrated significant clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with progression risks, highlighting issues with delayed treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Viewpoint - Clouding New Horizon (01952) saw a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Company Developments - NEFECON demonstrated substantial clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with existing progression risks, highlighting a delay in treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Insights - YunTing New Drug's core product, Naisukan (Budesonide enteric-coated capsules), has demonstrated clinical value in the new management strategy for IgA nephropathy, focusing on "etiological treatment, early treatment, and long-term treatment" [1][3] - The drug has shown effectiveness in special populations, including patients with severe renal impairment and children, reinforcing its position as a first-line treatment for IgA nephropathy [1] - The cumulative sales revenue of Naisukan reached nearly 1 billion yuan from January to September this year, marking it as one of the fastest-growing chronic disease innovative drugs in recent years [2] Group 1 - The real-world studies presented at ASN Kidney Week 2025 validate the clinical advantages of Naisukan, with evidence supporting its efficacy in early treatment for patients with proteinuria levels below 0.5g/d [1][2] - The introduction of Naisukan into the National Medical Insurance Directory in 2024 is expected to activate clinical demand significantly, with the reimbursement policy effective from January 1, 2025 [2] - YunTing New Drug is developing diagnostic testing reagents for IgA nephropathy, which are expected to fill the gap in non-invasive diagnosis in China, potentially replacing kidney biopsy as an auxiliary diagnostic method [2] Group 2 - The company anticipates that the deepening of clinical consensus and insurance coverage will enhance the market penetration of Naisukan, making it a core pillar for the company's performance growth [3] - The new management strategy for IgA nephropathy aims to provide patients with hope for delaying disease progression and improving long-term outcomes [3] - The clinical data for the next-generation BTK inhibitor EVER001 is promising, indicating potential coverage for a broader range of kidney disease indications [2]