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 Insights - Yunding Xinyao announced the successful enrollment of the first patient in its global multicenter Phase I clinical trial for the universal off-the-shelf cancer therapeutic vaccine EVM14 at NEXT Oncology Virginia in the United States [1] Group 1: Product Overview - EVM14 is a universal off-the-shelf cancer therapeutic vaccine targeting five tumor-associated antigens (TAA) [1] - The vaccine is intended 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) [1]

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]

Core Viewpoint - CloudTop New Horizon (01952) announced the granting of stock options and awards as part of its employee incentive plans, indicating a focus on employee retention and motivation [1] Group 1 - The company granted 1.2374 million stock options under the post-IPO stock option plan [1] - The company also granted 530,300 awards under the pre-IPO employee stock option plan, pending independent shareholder approval [1]

Core Viewpoint - Genting New Year (01952) announced the granting of stock options and awards as part of its employee incentive plans, which are subject to independent shareholder approval [1] Group 1 - The company granted 1,237,400 stock options under the post-IPO stock option plan [1] - The company also granted 530,300 awards under the pre-IPO employee stock option plan, pending independent shareholder approval [1]

Core Viewpoint - Genting New Year (01952.HK) announced the granting of stock options and awards as part of its employee stock option plans, indicating a strategic move to incentivize employees and align their interests with shareholders [1] Group 1 - The company granted 1,237,374 stock options under the post-IPO stock option plan [1] - Additionally, the company awarded 530,303 options under the pre-IPO employee stock option plan, pending independent shareholder approval [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該 等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 (1) 授出購股權 (2) 非豁免關連交易— 建議向關連人士授出獎勵 本公告乃根據上市規則第17.06A、17.06B及17.06C條刊發。 於2025年10月10日，董事會(i)根據首次公開發售後購股權計劃授出1,237,374份購 股權；及(ii)根據首次公開發售前僱員購股權計劃授出530,303份獎勵（ 須經獨立股 東批准 ）。有關上述授出的詳情如下： (1) 授出購股權 董事會宣佈，於2025年10月10日，本公司根據首次公開發售後購股權計劃向 執行董事兼董事會主席吳以芳先生（「吳先生」）授出1,237,374份購股權。 授出購股權的詳情如下： 授出日期： 2025年10月10日 所授出購股權的數目： 1,237,374份 所授出購股權的行使價： 56.6 ...