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。 ...

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]

10月14日，云顶新耀宣布其通用现货型肿瘤治疗性疫苗EVM14注射液（"EVM14"）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。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，拟用于治疗多种鳞状细胞癌，包括非小细胞肺鳞癌 （sq-NSCLC）和头颈部鳞状细胞癌（HNSCC）。 ...

Core Viewpoint - CloudTop New Horizon (1952.HK) has received IND approval for its mRNA tumor therapeutic vaccine EVM14, marking it as the first mRNA tumor vaccine to achieve dual IND approval in both China and the U.S., showcasing the company's enhanced global clinical development capabilities [1][2]. Group 1: Product Development - EVM14 is developed based on the company's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA), intended for the treatment of various squamous cell carcinomas [1]. - Preclinical trials demonstrated that EVM14 induced dose-dependent antigen-specific immune responses in mice and significantly inhibited tumor growth in multiple mouse models, while also showing the ability to induce immune memory and reduce tumor recurrence [1][2]. - EVM14's combination with immune checkpoint inhibitors has been shown to significantly enhance anti-tumor activity, supporting further exploration of combination therapies in clinical settings [1][2]. Group 2: Market Potential - The targeted tumor types for EVM14 represent a significant unmet medical need, with approximately 96% of squamous non-small cell lung cancer (sq-NSCLC) patients and 97% of head and neck squamous cell carcinoma (HNSCC) patients expressing at least one of the five TAA genes [2]. - EVM14 offers advantages over traditional therapies, including no need for HLA screening, 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 unlock hundreds of billions of dollars in potential, with the possibility of serving as a new type of cancer immunotherapy that is both broadly accessible and personalized [2]. Group 3: R&D Infrastructure - The rapid advancement of EVM14's development is supported by CloudTop New Horizon's comprehensive mRNA technology platform, which encompasses antigen design, sequence optimization, delivery system development, and large-scale production [3]. - The company holds all intellectual property rights and global interests related to its mRNA drug pipelines, including EVM14, EVM18 (CAR-T project), EVM16 (personalized tumor vaccine), and EVM15 (immunomodulatory vaccine) [3]. - EVM18 has completed several studies in non-human primates and plans to initiate clinical trials by the end of 2025, while EVM16 has started its first human clinical trial in China [3].

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Views - The in vivo CAR-T technology is emerging as a new hotspot in cell therapy, with significant investment opportunities in the domestic market. Major pharmaceutical companies are actively entering this field, with multiple high-value transactions occurring in 2025 [5][14] - Compared to traditional CAR-T, in vivo CAR-T offers advantages such as reduced manufacturing costs, shortened processing times, and improved accessibility for patients, making it applicable in various diseases including B-cell malignancies and autoimmune diseases [6][15] - The report highlights the performance of various sub-sectors within the pharmaceutical industry, noting that the hospital sector showed the highest increase, while the medical R&D outsourcing sector experienced the largest decline [7][24] Summary by Sections Section 1: In Vivo CAR-T Transactions - Numerous significant transactions in the in vivo CAR-T space have occurred in 2025, indicating strong interest and investment potential. Notable deals include AstraZeneca's acquisition of EsoBiotech for $1 billion and BMS's agreement to acquire Orbital Therapeutics for $1.5 billion [5][14] Section 2: Market Performance - In the second week of October 2025, the pharmaceutical sector declined by 1.20%, underperforming the CSI 300 index by 0.69 percentage points, ranking 25th among 31 sub-industries. The hospital sector saw the largest increase at 1.79% [7][18] - The report provides a detailed analysis of sub-sector performance, with the hospital sector leading gains and the medical R&D outsourcing sector facing the most significant losses [24][28] Section 3: Recommended Stocks - The report recommends several stocks for investment, including Shiyao Group, Sunshine Nuohuo, and Yuekang Pharmaceutical, among others [8][16]

Core Insights - Wu Yifang has joined Cloudbreak Capital as the Chairman of the Board of Cloudtop New Horizon after leaving Fosun Pharma, marking a new chapter in his career [1][2] Company Changes - Cloudtop New Horizon announced several board changes, including the appointment of Wu Yifang as Chairman, the transition of Fu Wei to a non-executive director, and the resignation of Feng Honggang as a non-executive director [1] - The adjustments aim to strengthen corporate governance, optimize strategic layout, and enhance overall company strength [1] Background of Wu Yifang - Wu Yifang has over 20 years of experience at Fosun Pharma, where he served as Chairman and CEO for nearly a decade, leading the company to achieve significant revenue growth [2][3] - Under his leadership, Fosun Pharma's revenue reached 41.07 billion yuan in 2024, with a steady increase from 30.31 billion yuan in 2020 [2] Strategic Focus - Wu Yifang's role at Cloudtop New Horizon will involve working closely with CEO Luo Yongqing to drive company development and provide strategic guidance on key initiatives, including strategic transactions and R&D innovation [1] - Cloudtop New Horizon is actively developing its mRNA business, which aligns with Wu Yifang's previous success in introducing BioNTech's mRNA technology to the Greater China region during his tenure at Fosun Pharma [4] Investment Management - Cloudtop New Horizon is a representative case incubated by Cloudbreak Capital, which manages assets worth $10.5 billion and focuses on the healthcare sector [4] - Cloudbreak Capital remains the largest shareholder of Cloudtop New Horizon, holding a 24.19% stake after a share placement [4] R&D Initiatives - Cloudtop New Horizon showcased its AI+mRNA technology platform during the "2025 Cloudtop New Horizon mRNA Innovation Technology Platform R&D Day," highlighting advancements in core pipelines for cancer and autoimmune diseases [5] - The company has initiated clinical trial applications for its therapeutic vaccines, EVM14 and EVM16, with EVM14's application officially accepted by the National Medical Products Administration [6]