Core Viewpoint - CloudTop New Horizon (01952) has initiated a Phase I study to evaluate the safety, tolerability, and preliminary efficacy of EVM14 monotherapy in selected patients with solid tumors, specifically squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. Group 1: Company Developments - CloudTop New Horizon's stock price increased by 6.02%, currently trading at HKD 40.18, with a trading volume of HKD 136 million [2][5]. - The Phase I trial aims to assess the safety and tolerability of EVM14, determining the recommended Phase II dose (RP2D) [2][5]. Group 2: Clinical Trial Objectives - The primary objective of the trial is to evaluate the safety and tolerability of EVM14 in patients with squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. - Secondary objectives include assessing the anti-tumor activity of EVM14, while exploratory objectives involve examining the correlation between biomarker expression and efficacy, as well as evaluating immunogenicity, pharmacokinetics, and anti-drug antibodies [2][5]. Group 3: Product Information - EVM14 injection is a biopharmaceutical intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. - Squamous non-small cell lung cancer is a common type of lung cancer characterized by symptoms such as cough and hemoptysis, diagnosed through imaging and pathology [2][5]. - Head and neck squamous cell carcinoma typically originates from mucosal surfaces, presenting with ulcers and masses, and is diagnosed through pathological examination [2][5].

消息面上，1月4日，据药物临床试验登记与信息公示平台数据显示，云顶新耀全资附属公司云顶新耀 (北京)医药科技有限公司在选定实体瘤患者中评估EVM14单药治疗的安全性、耐受性和初步有效性的I 期研究已启动。 本次试验主要目的为在鳞状非小细胞肺癌和头颈部鳞状细胞癌患者中评估EVM14单药治疗的安全性和 耐受性，确定治疗的RP2D；次要目的为评估其抗肿瘤活性。探索性目的包括探索生物标志物表达与有 效性的相关性，评估免疫原性、药代动力学和抗药抗体。 EVM14注射液为生物制品，拟适用于鳞状非小细胞肺癌、头颈部鳞状细胞癌患者的治疗。鳞状非小细 胞肺癌是肺癌常见类型，症状有咳嗽、咯血等，靠影像学和病理确诊；头颈部鳞状细胞癌多源于黏膜， 有溃疡、肿块等表现，病理检查可诊断。 智通财经APP获悉，云顶新耀(01952)盘中涨近6%，截至发稿，涨5.86%，报40.12港元，成交额9171.08 万港元。 ...

本次试验主要目的为在鳞状非小细胞肺癌和头颈部鳞状细胞癌患者中评估EVM14单药治疗的安全性和 耐受性，确定治疗的RP2D；次要目的为评估其抗肿瘤活性。探索性目的包括探索生物标志物表达与有 效性的相关性，评估免疫原性、药代动力学和抗药抗体。 EVM14注射液为生物制品，拟适用于鳞状非小细胞肺癌、头颈部鳞状细胞癌患者的治疗。鳞状非小细 胞肺癌是肺癌常见类型，症状有咳嗽、咯血等，靠影像学和病理确诊；头颈部鳞状细胞癌多源于黏膜， 有溃疡、肿块等表现，病理检查可诊断。 云顶新耀(01952)盘中涨近6%，截至发稿，涨5.86%，报40.12港元，成交额9171.08万港元。 消息面上，1月4日，据药物临床试验登记与信息公示平台数据显示，云顶新耀全资附属公司云顶新耀 (北京)医药科技有限公司在选定实体瘤患者中评估EVM14单药治疗的安全性、耐受性和初步有效性的I 期研究已启动。 ...

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]

Group 1 - Company shares of CloudTop New Medicine (01952) rose over 6%, reaching a price of 54.45 HKD with a trading volume of 142 million HKD [1] - The company announced the successful enrollment of the first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 at NEXT Oncology Virginia [1] - This clinical trial progress follows the approval of the Investigational New Drug (IND) application for EVM14 by both the FDA and NMPA [1] Group 2 - The development of EVM14 addresses significant clinical pain points in the treatment of squamous cell carcinoma, a condition with a large patient population and unmet medical needs [2] - EVM14 offers advantages such as no HLA screening requirement, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application potential in cancer treatment [2] - The mRNA tumor vaccine market is projected to reach 40.651 billion USD under neutral scenarios, with universal vaccines expected to have a higher penetration rate than personalized products due to cost advantages [2] - EVM14 is positioned to lead in clinical development amidst intense industry competition due to its differentiated advantages [2]

Core Insights - CloudTop New Horizon (01952) announced the successful enrollment of the first patient in the global multi-center Phase I clinical trial of its universal on-demand tumor therapeutic vaccine EVM14 at NEXT Oncology Virginia in the U.S. This milestone follows the approval of the Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) in China, marking a significant step in synchronized clinical development in both countries [1][2] Company Summary - EVM14 is based on CloudTop's self-developed mRNA technology platform and targets five tumor-associated antigens (TAA), intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [1] - The vaccine addresses significant unmet medical needs in the treatment of squamous cell carcinoma, which has a large patient population but currently lacks satisfactory treatment options [1] - EVM14 offers advantages such as no HLA screening requirement, on-demand supply, lower production costs, and applicability to multiple tumor types, showcasing broad application prospects in cancer treatment [1] Clinical and Preclinical Insights - Preclinical results demonstrated EVM14's potential by inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in multiple mouse models. It also showed the ability to induce immune memory, effectively reducing tumor recurrence [2] - The combination of EVM14 with immune checkpoint inhibitors has been shown to significantly enhance anti-tumor activity, supporting further exploration of combination therapies in clinical settings [2] - The lead researcher, Professor Lu Shun, emphasized the importance of tumor-associated antigen vaccines as a powerful complement to existing therapies, potentially reducing recurrence and aligning with global trends in cancer drug development [2] Industry Context - The mRNA field is experiencing a surge, with frequent strategic moves by global pharmaceutical companies. For instance, recent acquisitions include Bristol-Myers Squibb's $15 billion purchase of Orbital for its CAR-T therapy and RNA technology platform, and BioNTech's $1.25 billion acquisition of CureVac to integrate mRNA technology advantages [3] - The mRNA tumor vaccine market is projected to reach $40.651 billion under neutral scenarios, with universal vaccines expected to have a higher penetration rate than personalized products due to cost advantages [3] - EVM14 is positioned to lead in clinical development amidst intense industry competition, with a multi-center Phase I trial involving top institutions in both the U.S. and China focusing on the vaccine's safety and efficacy [3] Pipeline Highlights - EVM14 is just one highlight in CloudTop's mRNA pipeline, which also includes the autologous CAR-T project EVM18 expected to start clinical trials by the end of the year, the personalized tumor therapeutic vaccine EVM16 that has initiated its first human clinical trial in China, and the on-demand immune modulation vaccine EVM15 that has completed preclinical concept validation [4]

Core Insights - Yunding Xinyao announced the successful enrollment of the first patient in the global multicenter Phase I clinical trial of its universal therapeutic vaccine EVM14 at NEXT Oncology Virginia in the United States [2][3] - EVM14 is developed based on Yunding Xinyao's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA) for the treatment of various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [2][3] Group 1 - EVM14 has shown that approximately 96% of sq-NSCLC patients and 97% of HNSCC patients express at least one TAA gene [2] - The clinical centers participating in the trial include NEXT Oncology Virginia, University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the U.S., and Shanghai Chest Hospital in China [2] Group 2 - Preclinical trial results indicate that EVM14 induces a dose-dependent antigen-specific immune response in mice and significantly inhibits tumor growth in multiple mouse tumor models [3] - EVM14 has the potential to induce immune memory and reduce tumor recurrence, offering the possibility of long-term cancer-free survival for patients [3] - The CEO of Yunding Xinyao highlighted the large patient population with squamous cell carcinoma and the unmet medical needs due to the limitations of existing standard treatments [3]

Core Viewpoint - CloudTop New Drug (1952.HK) reported a strong performance in its 2025 interim results, with a revenue increase of 48% year-on-year, driven by its core product, Nefukang, which is expected to achieve significant sales growth in the coming years [1][2][4]. Financial Performance - The company achieved a revenue of 446 million RMB, with a gross margin of 76.4% after excluding non-cash items [1]. - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, and the total loss under non-IFRS standards narrowed by 31% [1]. - Cash reserves stood at 1.6 billion RMB, bolstered by a recent fundraising of approximately 1.553 billion HKD [1]. Product Performance - Nefukang, a treatment for IgA nephropathy, generated sales of 825 million RMB from January to August, with August sales alone reaching 520 million RMB [2][3]. - The company anticipates Nefukang's annual sales to reach between 1.2 billion and 1.4 billion RMB, with projections for 2026 sales between 2.4 billion and 2.6 billion RMB [2][3]. - The product is the only IgA nephropathy drug included in the medical insurance system across 29 provinces, significantly enhancing patient accessibility [3]. Market Potential - The market for IgA nephropathy treatment is substantial, with over 5 million patients in China and 1 million diagnosed cases [3]. - The company has expanded its nephrology sales team to 160 members to meet growing demand and has received approval for production capacity expansion [3]. R&D Progress - The company has made significant advancements in its self-developed pipeline, particularly in mRNA cancer therapeutic vaccines and CAR-T platforms [4]. - The personalized tumor therapeutic vaccine EVM16 has initiated its first human clinical trial in China, with positive preliminary data [4]. - The universal tumor therapeutic vaccine EVM14 has received FDA approval for clinical trials, with patient enrollment expected to begin by September 2025 [4]. Strategic Developments - The company successfully removed the "B" mark from its Hong Kong stock, reflecting market confidence in its R&D pipeline and commercialization capabilities [7]. - A recent fundraising effort raised approximately 1.5725 billion HKD, indicating strong interest from international long-term funds [7]. - The company has increased its stake in I-Mab to 16.1%, becoming its largest shareholder, which complements its mRNA vaccine and CAR-T pipeline [7]. Future Outlook - The company aims to leverage its dual-driven strategy focusing on Nefukang and VisiPing as key products, with projected peak sales exceeding 25 billion RMB [8]. - The integration of AI and mRNA technology platforms is expected to drive early-stage R&D and internationalization efforts [8].

Group 1 - The core point of the news is that Yunding Xinyao's EVM14 injection, a universal therapeutic vaccine for tumors, has received formal acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, marking a significant step in the company's global innovation strategy [1] - EVM14 is based on Yunding Xinyao's proprietary mRNA technology platform and targets five tumor-related antigens, intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [1] - The company has prepared thoroughly for the clinical trials of EVM14, with the first batch of GMP clinical trial samples released from its Jiaxing factory on June 9, 2025, to support trials in both the US and China [1] Group 2 - In the mRNA treatment field, the company has proactively developed multiple mRNA therapeutic drugs, aiming to create a fully integrated and clinically validated AI+mRNA platform [2] - The company has established a comprehensive end-to-end industrial chain platform that enhances efficiency from antigen design, mRNA sequence optimization, LNP delivery technology to large-scale production [2] - During the "mRNA Innovation Technology Platform R&D Day" held at the end of June, the company revealed that it has engaged with multiple top 20 global pharmaceutical companies, attracting interest for collaboration from several multinational pharmaceutical firms [2]

Core Insights - The core viewpoint of the articles is that CloudTop New Horizon (1952.HK) has made significant progress with its universal tumor therapeutic vaccine EVM14, which has received formal acceptance for clinical trial application (IND) from the National Medical Products Administration (NMPA) in China, marking a key step in its global regulatory pathway [1][2][3] Group 1: Product Development - EVM14 is based on CloudTop's proprietary mRNA technology platform and targets five tumor-associated antigens, intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2] - EVM14 has shown significant therapeutic potential in preclinical studies, inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in various mouse models [2] - The preclinical data also indicates that EVM14 can enhance anti-tumor activity when used in combination with immune checkpoint inhibitors (ICIs), supporting further exploration of combination therapies in clinical settings [2] Group 2: Market Potential and Strategic Positioning - The global mRNA therapeutic market is projected to exceed $19.68 billion in 2024 and reach $42.64 billion by 2034, indicating a substantial market opportunity for mRNA-based therapies [5] - CloudTop has established a fully integrated AI+mRNA platform that encompasses the entire value chain from antigen design to large-scale production, enhancing efficiency in drug development [5][6] - The company has engaged in extensive outreach with top global pharmaceutical companies, indicating strong interest in collaboration and positioning itself as a core competitor in the mRNA field [7] Group 3: Clinical Trial Readiness - CloudTop has prepared thoroughly for the clinical trials of EVM14, with the first batch of GMP clinical trial samples released from its JiaShan facility, supporting trials in both the U.S. and China [4] - The clinical trial centers include prestigious institutions such as the MD Anderson Cancer Center in the U.S. and Shanghai Chest Hospital in China, enhancing the credibility and reach of the clinical studies [4]