云顶新耀(1952.HK)EVM14临床试验申请获国家药监局受理，mRNA平台迎来“中美双报”里程碑

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]