通用型现货肿瘤治疗性疫苗EVM14

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云顶新耀(01952):mRNA平台开发稳步推进,可逆BTK膜性肾病数据优异;上调目标价
BOCOM International· 2025-07-02 08:06
Investment Rating - The report assigns a "Buy" rating to the company, with a target price of HKD 72.50, indicating a potential upside of 16.6% from the current closing price of HKD 62.20 [1][27]. Core Insights - The mRNA platform development is progressing steadily, with excellent data on the reversible BTK inhibitor for membranous nephropathy. The target price has been raised to reflect these developments [2][6]. - The company has showcased its fully integrated and localized AI + mRNA platform, highlighting several mRNA tumor drug developments, including personalized and universal therapeutic vaccines [6]. - The reversible BTK inhibitor EVER001 has shown promising results in clinical trials for treating membranous nephropathy, with significant reductions in anti-PLA2R antibody levels and urinary protein levels [6]. Financial Overview - Revenue projections for the company are as follows: - 2023: RMB 126 million - 2024: RMB 707 million - 2025E: RMB 1,660 million - 2026E: RMB 2,552 million - 2027E: RMB 3,752 million - Year-on-year growth rates are projected at 884.5% for 2023, 461.2% for 2024, and 134.9% for 2025 [5][28]. - The net profit (loss) is expected to improve from a loss of RMB 844 million in 2023 to a profit of RMB 743 million by 2027 [5][28]. - The company’s market capitalization is approximately HKD 20.2 billion, with an average daily trading volume of 13.36 million shares [3]. Valuation Metrics - The report indicates a peak sales estimate for EVER001 exceeding RMB 1.5 billion, with a target valuation of HKD 72.50 corresponding to a market cap of HKD 237 billion and a price-to-sales ratio of 1.8 times at peak revenue [6][24]. - The company’s financial forecasts have been adjusted, reflecting a more cautious outlook on product revenue ramp-up, with slight downward revisions in revenue estimates for 2025-2027 [6][23].
中金:维持云顶新耀(01952)“跑赢行业”评级 升目标价至80港元
智通财经网· 2025-07-01 08:13
Core Viewpoint - CICC maintains the profit forecast for CloudTop New Horizon (01952) for 2025 and 2026, adjusting the target price by 14.3% to HKD 80.0, indicating a potential upside of 28.6% from the current stock price [1] Company Status - On June 27, CloudTop New Horizon held an mRNA innovation technology platform R&D day, showcasing three core product lines: the universal on-demand therapeutic vaccine EVM14, the personalized therapeutic vaccine EVM16, and the autologous CAR-T project. The company has established extensive contacts with global top 20 pharmaceutical companies, focusing on leveraging international partnerships to promote the global layout of innovative drugs [2] Complete mRNA R&D and Production Platform - The company has successfully built a comprehensive mRNA platform covering antigen design, algorithm optimization, LNP delivery systems, CMC process development, and GMP industrial production. Key patents include: 1) self-developed third-generation AI algorithm optimization, significantly enhancing target protein expression; 2) proprietary LNP delivery platform with over 500 internal lipid types, capable of liver and extrahepatic delivery, supporting both "passive" and "active" targeting strategies; 3) two major bases in Zhangjiang and Jiashan ensuring process development and industrial production [3] Project Progress - EVM16: Utilizes the company's self-developed EVER-NEO-01 "MiaoSuan" AI algorithm system to identify patient-specific tumor cell mutations and design mRNA vaccines encoding dozens of new tumor antigens. Preclinical data indicates good safety and strong immunogenicity, with IIT research completing the first patient dosing in March this year [4] - EVM14: A universal on-demand therapeutic bivalent vaccine targeting five tumor-related antigens, intended for squamous cell carcinoma, including non-small cell lung cancer and head and neck cancer. Preclinical data shows EVM14 can induce a strong immune response and can be combined with IO drugs to enhance anti-tumor activity, with FDA approval for clinical trials obtained in March [4] - Autologous CAR-T: Developed based on the proprietary LNP (tLNP) system, demonstrating efficient T cell transfection, CAR expression, and B cell clearance effects in monkey models [4]
mRNA已成国际药企关注焦点 云顶新耀能否从百亿元规模肿瘤疫苗市场中分得一杯羹?
Mei Ri Jing Ji Xin Wen· 2025-06-30 11:06
Core Viewpoint - CloudTop New Horizon (HK01952) has seen a significant stock price increase of 28.6% over the past seven trading days, driven by the presentation of its mRNA technology platform and three products targeting autoimmune diseases at a recent R&D event [1][2]. Company Developments - The company showcased its mRNA technology platform, including the universal tumor therapeutic vaccine EVM14, personalized tumor therapeutic vaccine EVM16, and autologous CAR-T project [1][3]. - EVM14 is set to begin a global multi-center Phase I clinical trial (EVM14 C101), with the first patient expected to be enrolled by Q3 2025 [1][3]. - EVM16 has shown efficacy in mouse melanoma models and is the company's first personalized mRNA tumor vaccine to enter clinical stages, with initial patient dosing expected to be completed by March 2025 [3][4]. Business Strategy - The CEO emphasized a selective business development strategy, focusing on leveraging international partnerships to enhance the global footprint of innovative drugs [1][4]. - The company aims to utilize its mRNA technology platform for developing both preventive and therapeutic mRNA products, with a focus on therapeutic vaccines [2][4]. Market Position - CloudTop New Horizon's mRNA platform has become a focal point for international pharmaceutical companies, potentially accelerating the commercialization of its products [4][7]. - The company has established a comprehensive industry chain platform that includes antigen design, sequence optimization, delivery systems, and large-scale production capabilities [7][8]. Industry Context - The global mRNA tumor vaccine market is projected to reach $21 billion by 2035, with the domestic market expected to reach 10 billion RMB [7]. - Compared to international leaders like BioNTech and Moderna, which have advanced their mRNA tumor vaccine pipelines to Phase II and III clinical trials, CloudTop New Horizon is still in the early stages of development [5][6]. Technical Challenges - Efficient delivery systems remain a significant bottleneck for mRNA vaccines, with limited suppliers for lipid nanoparticles (LNP) and ongoing patent disputes hindering development [8]. - CloudTop New Horizon has developed its proprietary LNP delivery technology, with a rich internal lipid library exceeding 500 types to meet the needs of various projects [8].