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]

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]

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]