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]

智通财经APP获悉，云顶新耀(01952)早盘涨超6%，截至发稿，涨6.66%，报54.45港元，成交额1.42亿港 元。 智通财经APP在《云顶新耀（01952）mRNA肿瘤疫苗EVM14接连突破：中国获批临床后，美国一期首 患成功入组》中指出，EVM14的研发，正直击当前鳞癌治疗的临床痛点。目前鳞癌患者群体庞大，但 现有标准治疗仍未实现令人满意的治疗效果，存在巨大的未满足医疗需求。作为通用现货型疫苗， EVM14具有无需HLA筛选、可现货供应、生产成本较低、适用于多瘤种等优势，在肿瘤治疗领域展现 出广阔应用前景。据预测，mRNA肿瘤疫苗市场在中性情景下规模可达406.51亿美元，其中通用型疫苗 因成本优势，渗透率将远超个性化产品。而EVM14凭借差异化优势，在激烈的行业竞争中实现了临床 开发进程的领跑。 消息面上，据云顶新耀官微消息，10月14日，公司宣布其通用现货型肿瘤治疗性疫苗EVM14注射液的 全球多中心I期临床试验在美国临床研究机构NEXT Oncology Virginia成功入组首例患者。这是继EVM14 新药临床试验申请(IND)在美国食品药品监督管理局(FDA)和中国国家药品监督管理局(N ...

Core Insights - Cloud-based innovative pharmaceutical company, CloudTop New Horizon, has successfully enrolled its first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 in the United States, following the approval of its Investigational New Drug (IND) application by the National Medical Products Administration of China [1][2] Group 1: Vaccine Development - EVM14 targets five tumor-associated antigens (TAA) and is intended for the treatment of various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [2] - The vaccine is based on CloudTop's self-developed mRNA technology platform, addressing unmet medical needs in current squamous carcinoma treatments [2] Group 2: Clinical and Market Potential - EVM14 has shown the ability to induce immune memory in preclinical studies, potentially reducing tumor recurrence and offering patients the possibility of "long-term cancer-free survival" [2] - As a universal on-demand vaccine, EVM14 has advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application prospect in tumor treatment [2] Group 3: Future Developments - Besides EVM14, CloudTop has several other promising products, including the autologous CAR-T project EVM18, which is expected to initiate clinical trials by the end of the year, and the personalized tumor therapeutic vaccine EVM16, which has already started its first human clinical trial in China [2]

Core Insights - CloudTop New Horizon's EVM14 injection, a universal therapeutic vaccine for cancer, has successfully enrolled its first patient in a global multi-center Phase I clinical trial in the U.S. [1] - The vaccine received approval for its Investigational New Drug (IND) application from China's National Medical Products Administration, marking a significant milestone in synchronized clinical development between China and the U.S. [1] - EVM14 targets five tumor-associated antigens (TAA) and aims to treat various squamous cell carcinomas, addressing unmet medical needs in the current treatment landscape [1][2] Company Developments - EVM14 is based on CloudTop's self-developed mRNA technology platform and is designed to be a readily available treatment option without HLA screening, with lower production costs and applicability across multiple tumor types [1] - The vaccine has shown promising preclinical results, inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in mouse models [2] - EVM14's ability to induce immune memory and reduce tumor recurrence positions it as a potential long-term solution for cancer patients [2] Industry Context - The mRNA sector is experiencing rapid growth, with significant investments and acquisitions by major pharmaceutical companies, indicating a competitive landscape [3] - The global mRNA tumor vaccine market is projected to reach $40.651 billion, with universal vaccines expected to have a higher penetration rate due to cost advantages [3] - CloudTop's EVM14 is leading in clinical development amidst fierce competition, with participation from top institutions in both China and the U.S. for the ongoing Phase I trial [3] Technological Advancements - CloudTop has established an integrated AI+mRNA platform that enhances mRNA expression levels and supports the entire vaccine development process from antigen design to large-scale production [4] - EVM14 is one of several promising projects in CloudTop's pipeline, which includes EVM18, a CAR-T project expected to start clinical trials by the end of the year, and EVM16, a personalized cancer vaccine that has already begun human trials in China [4]

10月14日，云顶新耀(01952)宣布，其通用现货型肿瘤治疗性疫苗EVM14注射液的全球多中心I期临床试 验，在美国NEXT Oncology Virginia成功入组首例患者。就在前一日(10月13日)，该疫苗的新药临床试 验申请(IND)刚获中国国家药品监督管理局批准。这一中美同步突破的里程碑事件，不仅标志着这款创 新疫苗正式迈入中美同步临床开发新阶段，也让中国药企在全球mRNA肿瘤治疗赛道的竞争力再度凸 显。 据预测，mRNA肿瘤疫苗市场在中性情景下规模可达406.51亿美元，其中通用型疫苗因成本优势，渗透 率将远超个性化产品。而EVM14凭借差异化优势，在激烈的行业竞争中实现了临床开发进程的领跑。 作为基于云顶新耀自研mRNA技术平台的产物，EVM14是一款靶向5个肿瘤相关抗原(TAA)的通用现货 型肿瘤治疗性疫苗，拟用于治疗非小细胞肺鳞癌、头颈部鳞状细胞癌等多种鳞状细胞癌。 此次EVM14全球多中心I期临床试验，集结了中美顶尖机构，包括美国的NEXTOncologyVirginia、德州 大学安德森癌症中心、纪念斯隆-凯特琳癌症中心，以及中国的上海胸科医院等，试验将重点观察疫苗 的安全性与疗效。 ...

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 Insights - The company YunTing Xinyao (1952.HK) has received formal acceptance of its IND application for the universal tumor therapeutic vaccine EVM14 by the National Medical Products Administration (NMPA) in China, marking a significant step in its global regulatory pathway [1][2] - EVM14 is designed to target five tumor-associated antigens and is intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma, having previously received FDA approval for clinical trials in March 2025 [2][3] - The vaccine has shown promising preclinical results, inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in various mouse models, while also demonstrating the ability to induce immune memory [2][3] Company Developments - The company has successfully released its first batch of GMP clinical trial samples from its JiaShan factory, which will support clinical trials in both the U.S. and China, with collaboration from leading clinical trial centers [2][3] - EVM14's characteristics, such as no need for HLA screening, on-demand supply, and lower production costs compared to personalized tumor neoantigen vaccines, position it favorably in the tumor treatment market [3][4] - The mRNA tumor vaccine market is viewed positively, with potential to become a new type of cancer immunotherapy that combines broad accessibility with personalized treatment, potentially unlocking a market worth hundreds of billions [3][4] Technological Advancements - The progress of EVM14 reflects the comprehensive capabilities of the company's mRNA platform, which integrates AI technology for mRNA sequence design and optimization, enhancing mRNA expression levels [4][5] - The company has a rich pipeline, including personalized tumor vaccine EVM16, which has shown good immunogenicity and efficacy in early studies, and an autologous CAR-T project expected to identify its first clinical candidate within the year [4][5] - The successful "dual submission" of EVM14 reinforces the company's end-to-end capabilities in antigen design, LNP delivery systems, and industrial production, laying a solid foundation for future clinical advancements and commercialization [5]

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]