个性化肿瘤治疗性疫苗EVM16

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200亿嘉兴药企,空降新董事长
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-11 01:16
离开任职20年的复星医药系,吴以芳确认新去向。 10月10日,总部位于嘉兴的创新药企云顶新耀公告称,吴以芳成为公司新一任执行董事、董事会主席。 原董事会主席傅唯,则调任为董事会荣誉主席。傅唯是康桥资本CEO,后者是云顶新耀的主要股东,在资金、资源和战略等方面给予强力支持。 在接受新任命的前一天,吴以芳宣布加盟康桥资本,成为执行运营合伙人。 云顶新耀执行董事、董事会主席吴以芳 吴以芳在制药领域拥有30多年的专业经验,将复星医药改造为一家创新药企业。 对处于自研转型关键期的云顶新耀,吴的到来或许能注入新动能,其工作重点,将放在"战略交易、研发创新以及关键利益方管理"。 有业内人士向《21CBR》记者表示,吴在销售网络建设和医保谈判的经验,也有助于云顶新耀销售团队的扩张。 老将上马 1969年出生的吴以芳,今年56岁,其职业生涯几乎贯穿了中国医药产业的整个发展周期。 他早年在徐州生物化学制药厂(万邦医药的前身),从生产、财务等基层岗位做起,一路晋升至副厂长。 随着企业改制并入复星医药体系,吴以芳自2016年起,担任复星医药总裁兼CEO,全面负责集团运营。 到今年9月底卸任,他在复星医药体系内服务超过20年。其间,推 ...
从复星医药辞职后,吴以芳火速加盟康桥资本并出任云顶新耀董事会主席
Mei Ri Jing Ji Xin Wen· 2025-10-10 14:14
从复星医药(600196)离职后,医药老将吴以芳很快宣布加盟康桥资本并出任云顶新耀董事会主席,开 启其职业生涯的新篇章。 公开资料显示,吴以芳于1987年进入徐州生物化学制药厂,历任技术员、主任、生产科长等职。 1997年起,吴以芳先后担任徐州(万邦)生物化学制药厂副厂长、徐州万邦生化制药有限公司副总经 理。2004年4月,万邦生化改制,加入复星医药集团,成为复星医药控股子公司。吴以芳也由此加入复 星医药集团,并历任江苏万邦总裁、复星医药高级副总裁、首席执行官等职。 2020年10月至2025年4月,吴以芳任复星医药董事长,期间推动集团实现全球化业务布局,制药业务分 设为创新药、仿制药及制造、疫苗三个事业部。2020年至2024年,复星医药分别实现营收303.1亿元、 390.1亿元、439.5亿元、414.0亿元和410.7亿元。 今年4月29日,吴以芳递交书面辞职函,因工作安排调整辞去复星医药董事长职务,并由执行董事改任 非执行董事。6月24日,复星医药召开股东会,完成董事会换届选举,陈玉卿正式接替吴以芳担任复星 医药董事长一职。9月30日,复星医药发布公告称,吴以芳向董事会申请辞去非执行董事职务,正式告 ...
复星医药前董事长吴以芳加盟云顶新耀,任董事会主席
Di Yi Cai Jing· 2025-10-10 03:20
吴以芳又有了新职。 现年56岁的吴以芳在制药行业拥有逾三十年的丰富专业经验。在加入云顶新耀之前,他曾任复星国际执 行总裁,并在复星医药担任董事长兼首席执行官近十年,期间,作为管理团队的核心成员,主导复星医 药转型为全球领先的生物制药企业,并成功为大中华区引入BioNTech的mRNA技术。此外,吴以芳还联 合创立万邦生化医药,并担任董事长兼首席执行官,为该企业在生物医药创新领域奠定了坚实基础。 吴以芳熟悉的方向之一,与云顶新耀的业务存在重合。 当前,云顶新耀正在大力发展mRNA业务,公司已构建国际领先的、完全整合且本地化的AI+mRNA平 台,重点推进肿瘤和自身免疫疾病领域的产品管线开发,包括通用型现货肿瘤治疗性疫苗EVM14、个 体化肿瘤治疗性疫苗EVM16,以及自体生成CAR-T项目。其中,云顶新耀自主研发的首款个性化 mRNA治疗性肿瘤疫苗EVM16的IIT研究已在今年3月于北京大学肿瘤医院顺利完成首例患者给药。 云顶新耀也在持续深化"授权引进+自主研发"这样的"双轮驱动"战略布局。凭借稳健的资金储备和不断 增强的研发及商业化能力,公司力争在2025年下半年实现经营性盈利。 在10月9日成为康桥资本Ex ...
云顶新耀上半年营收同比增长48% 下半年有望迎来盈利拐点
Zheng Quan Ri Bao· 2025-08-29 07:06
Group 1 - The company is confident in achieving its annual sales target of 1.6 billion to 1.8 billion yuan, aiming for operational profitability by the second half of 2025 [1][2] - The core product, Nefikastat, has shown exceptional performance with sales revenue of 303 million yuan in the first half of the year, representing an 81% year-on-year increase [1] - As of August, the sales team in the nephrology sector has expanded to 190 members, covering 1,000 target hospitals, with approximately 30,000 new patients expected by the first half of 2025 [1] Group 2 - The company reported a revenue of 446 million yuan for the first half of 2025, a 48% year-on-year increase, with a gross margin of 76.4% [4] - The non-IFRS loss has narrowed by 31% year-on-year, indicating a continued approach towards profitability [4] - The cash balance at the end of the first half reached 1.6 billion yuan, supplemented by recent fundraising of 1.553 billion HKD, bringing total cash reserves to over 2.5 billion yuan [4] Group 3 - The company is focusing on its self-developed core pipeline and accelerating the clinical development and internationalization of global rights products [1] - The product pipeline includes personalized tumor therapeutic vaccines, mRNA tumor therapeutic vaccines, and self-generated CAR-T projects [2] - The CEO emphasized the dual-driven strategy to establish a commercial platform for high-potential markets and to advance the self-generated CAR-T and mRNA vaccine platforms [2]
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].