Core Insights - The mRNA technology, initially recognized for its role in COVID-19 vaccines, is now being explored for broader therapeutic applications, particularly in oncology and autoimmune diseases [2][3] - The mRNA vaccine pipeline has seen a decline post-pandemic, with significant revenue drops reported by major players like Moderna and BioNTech [3][4] - Cloud-based innovations in mRNA technology, such as personalized cancer vaccines, are emerging as potential game-changers in the pharmaceutical industry [4][5] Industry Overview - The mRNA vaccine and therapy market is projected to grow at a compound annual growth rate (CAGR) of 16.8%, increasing from $46.83 billion in 2023 to $101.8 billion by 2028 [13] - The industry is witnessing a shift from pandemic-driven demand to a focus on personalized medicine and innovative treatment solutions [4][5] Company Developments - Cloud-based pharmaceutical company, CloudTop New Horizon, has developed an AI+mRNA platform and is advancing its pipeline in personalized cancer vaccines, with EVM16 showing promising clinical results [5][6] - The company has established a GMP production facility in China, enabling localized production of mRNA drugs and addressing scalability challenges in the industry [11] - CloudTop's dual strategy of "License In" and "License Out" is enhancing its revenue streams and positioning it for international collaborations with top pharmaceutical companies [12] Competitive Landscape - The mRNA technology race is intensifying, with various companies, including CloudTop, competing to establish their platforms and pipelines [5][6] - CloudTop's differentiation lies in its focus on personalized vaccines and a universal design for broader applicability, aiming to reduce costs and production times [7][8] - The integration of AI in mRNA development is seen as a critical factor for success, with CloudTop's proprietary algorithms enhancing its capabilities in identifying tumor antigens [10]

Group 1 - BioNTech's research on mRNA neoantigen vaccines shows potential in treating pancreatic cancer by inducing long-lived CD8+ T cell responses, offering new hope for cancer immunotherapy [1] - The challenge of tumor recurrence and metastasis remains significant in clinical treatment, highlighting the importance of mRNA technology in immune response [1] - Cloud Health's CEO discusses how mRNA technology stimulates T and B cells to create specific immune responses against tumor cells, forming immune memory to reduce recurrence risk [1] Group 2 - mRNA technology shifts drug development from "molecular screening" to "information design," transforming the human body into a smart factory for protein drug production [2] - Despite its advantages, the delivery system poses a major barrier for mRNA technology, as synthesized mRNA is prone to degradation when entering the human body [2] - Cloud Health has made breakthroughs in delivery technology, establishing a proprietary LNP (lipid nanoparticle) delivery platform with patents in ionizable and stealth lipids [2] Group 3 - The third-generation AI algorithm significantly enhances target protein expression levels, enabling Cloud Health to advance mRNA tumor drug development [3] - EVM16 is Cloud Health's first personalized mRNA tumor vaccine entering clinical stages, with the first patient dosing completed in March 2025 [3] - EVM14 is a universal therapeutic vaccine targeting five tumor-related antigens, intended for the treatment of squamous cell carcinoma [3]

21世纪经济报道记者 韩利明 上海报道 从传统小分子到小分子靶向药物，再逐步拓展至大分子、细胞疗法与mRNA疗法，生物医药领域的每一 次研发突破都在为临床诊疗拓宽路径。其中，mRNA技术在新冠疫情期间通过疫苗研发迅速完成商业化 验证，Moderna、BioNTech和CureVac借此成长为全球mRNA巨头。然而，随着疫情影响消退，mRNA行 业也步入转型关键期。 在技术应用层面，麦高证券研报指出，mRNA肿瘤疫苗有望成为一种适用于泛癌种、具备高可及性、能 够实现现货化与个性化兼具的新型肿瘤免疫疗法。通过广泛的联合应用，以辅助疗法作为切入点，该疫 苗有望逐步释放出数百亿美金的市场潜力。 在企业战略布局上，特别是进入2025年，行业巨头动作频频。其中，BioNTech通过战略收购布局 ADC、PD(L)1/VEGF双抗等热门肿瘤管线之余，更是在今年 6月斥资12.5亿美元收购CureVac，强化其在 研mRNA癌症免疫疗法的全链条能力。而全力押注mRNA技术的Moderna，也呈现出喜忧参半的发展态 势。 与此同时，大洋彼岸的中国正处于创新药物爆发期，mRNA赛道呈现出冰火两重天的格局。既有明星药 企黯然退场， ...

2025.06. 20 本文字数：1762，阅读时长大约3分钟 作者 | 第一财经 吴斯旻 去年，我国新药注册临床试验数量再创历史新高。其中，细胞与基因治疗药物、"跨界药王"司美格鲁肽以 及儿童新药研发的市场热度高涨。 19日，国家药监局药审中心（CDE）发布《中国新药注册临床试验现状年度报告（2024年）》（下 称"报告"）。CDE表示，该报告旨在展示中国新药注册临床试验现状，进一步提升临床试验的透明度，为 新药研发与审评审批提供科学参考。报告分析基于药物临床试验登记与信息公示平台的临床试验数据。 第一财经梳理近五年CDE年度报告发现，2024年，我国新药注册临床试验数量为近五年新高。继2023 年"药物临床试验登记与信息公示平台登记临床试验总量首次突破4000项"后，2024年这一数量逼近 5000项（4900项），较上一年增长了13.9%。 ▲来源：《中国新药注册临床试验现状年度报告（2024年）》 生物制品开展临床试验数量前10位品种中，司美格鲁肽注射液同样开展临床试验数量最多，有15项。也 就是说，去年我国司美格鲁肽临床试验注册数量已达29项。 ▲来源：《中国新药注册临床试验现状年度报告（2024年 ...

广州知识城，恒瑞医药研发基地的外墙在阳光下泛着光。步入大门，走廊一侧的生产车间内，高度智能 化的生产线悄然运转，机械臂精准分装药品，整个车间鲜见工作人员身影。而在墙上的场地图却显示， 更多区域将作为预留区。 巨头转身 根据Wind数据，截至2025年6月16日，恒瑞医药在A股的市值为3552亿元人民币，在港股的市值为3884 亿港元。尽管市值依旧庞大，但公司面临市场波动的挑战。成立于2010年的后起之秀百济神州在近几年 紧咬其后。 时光回溯至2020年末，恒瑞医药市值一举突破6100亿元大关，傲然屹立于A股医药板块之巅。然而，在 荣耀的光辉之下，暗影悄然浮现。那一年，药品集采的巨斧劈开仿制药的黄金时代。恒瑞医药，这个以 仿制药起家的行业巨头，自2020年国家药品集采政策全面实施以来，其入围集采的药品价格普遍遭遇了 大幅度的下调。 "预留区域可用于快速扩产。同时，工厂正在建设mRNA生产线，承接mRNA肿瘤疫苗项目，负责一 期、二期临床样品生产。" 一位恒瑞医药研发基地负责人员对记者介绍道。 当仿制药市场的价格战持续挤压利润空间，"以仿养创"的传统模式已难以为继。有行业数据显示，近三 年已有超过60%的仿制药企 ...

Core Viewpoint - Baize Medical Group Limited is planning to go public on the Hong Kong Stock Exchange, with a global offering of 133 million shares and an expected fundraising amount between HKD 562 million and HKD 898 million [1][3]. Company Overview - Baize Medical was established in July 2017 and is primarily engaged in investment and provision of medical services related to oncology, operating 8 hospitals across various provinces in China [5][6]. - The company has a registered capital of RMB 1.234 billion and is fully controlled by Beijing Baibai Medical Management [3][5]. Financial Performance - The revenue for Baize Medical for the years 2022, 2023, and 2024 was approximately RMB 803 million, RMB 1.072 billion, and RMB 1.189 billion, respectively, showing a growth trend despite ongoing losses [6][7]. - The net losses for the same years were RMB 75.5 million, RMB 24.4 million, and RMB 3.6 million, indicating a narrowing loss margin [6][8]. - Adjusted net profits (non-IFRS) for the years were approximately -RMB 75.3 million, -RMB 9.6 million, and RMB 12.5 million, with adjusted EBITDA of RMB 35.3 million, RMB 122.3 million, and RMB 135.6 million [8]. Business Operations - The company operates 6 for-profit hospitals and manages 2 non-profit hospitals, focusing on cancer-related medical services, including diagnosis, treatment, rehabilitation, and palliative care [5][6]. - As of December 31, 2024, Baize Medical's hospitals employed 1,119 practicing physicians and had a total of 2,829 medical professionals providing various oncology services [9][10].

展望2025年，公司还有巨大的价值提升空间： 大单品耐赋康今年年初正式纳入医保后销售放量超预期，至今已累计了超过2万名新患者; EVER001(BTK抑制剂)已在6月初的ERA大会上公布了在膜性肾病中十分亮眼的初步数据(截至12月17 日)，还会在2025年下半年公布1年随访的数据，逐渐成熟的临床数据已不断吸引跨国公司的合作意愿， 将助力公司在年内落地出海授权合作，最大化该产品的全球价值； 云顶新耀称，本次交易将进一步拓宽该公司高质量、关注基本面的长线持有国际专业机构投资人阵营， 优化投资人结构，并为公司的长期发展提供支持，这也真实的反应了国际投资人对云顶新耀价值的认可 和未来的信心。 本次大宗交易之后，康桥资本仍将继续持有超过25%的股权，保持其作为云顶新耀控股股东的地位和信 心，并将继续赋能公司。 mRNA平台也步入收获期，EVM16个性化肿瘤疫苗预计于今年完成1a部分的入组及读出初步的人体免 疫原性数据，EVM14通用现货型肿瘤相关抗原疫苗已在美国获得IND批准，并将于下半年实现首例患者 入组，下半年还将获得中国的IND批准。自体生成CAR-T项目近期将完成大动物临床前验证。已有多家 跨国大型制药公司表 ...

Core Viewpoint - The article discusses the establishment of a regulatory framework for advanced therapy medicinal products (ATMPs) in China, aiming to enhance the quality of the industry and align with international standards [1][2][4]. Group 1: Definition and Classification - The draft document defines "advanced therapy medicinal products" as those developed, produced, and regulated according to pharmaceutical regulations, including cell and gene therapies [2][4]. - ATMPs in China are categorized into three main types: cell therapy medicinal products (CTMPs), gene therapy medicinal products (GTMPs), and others based on their material basis and active ingredients [2][6]. Group 2: Industry Development and Global Position - The advanced therapy sector is identified as a core area of life sciences, crucial for fostering future industries and promoting high-quality development in the bio-economy [3][4]. - As of 2024, China has made significant progress in CGT drug development, with 4 out of 17 global CGT therapies approved, and 6 out of over ten CAR-T products approved worldwide [3][4]. Group 3: Regulatory Challenges and International Coordination - The current lack of regulatory definitions and industry consensus in China poses challenges for the development, technical review, and regulation of advanced therapies [4][6]. - The draft aims to unify the naming, scope, and classification of advanced therapy products, facilitating faster reviews and approvals while enhancing international regulatory coordination [1][4]. Group 4: Specific Regulatory Provisions - The draft specifies that certain products, such as blood components and reproductive cells, are excluded from the definition of ATMPs [6]. - CAR-T therapies are classified as "ex vivo gene-modified cell products," differing from classifications by other global regulatory bodies, reflecting a focus on the material basis and characteristics of the products [6][7]. Group 5: Future Prospects and Inclusivity - The classification framework is designed to be forward-looking and inclusive, allowing for the integration of new technologies and products as they develop [7]. - The draft has incorporated feedback from over 70 industry experts and representatives, indicating a collaborative approach to regulatory development [7].

每经记者 甄素静 每经编辑 张益铭 丨2025年4月29日 星期二丨 NO.1 药明康德一季度净利润同比增长89.06% 4月28日，药明康德公告称，2025年第一季度实现营业收入96.55亿元，同比增长20.96%；归属于上市公 司股东的净利润36.72亿元，同比增长89.06%。 点评：药明康德2025年一季度营收、净利双增，展现强劲增长势头，凸显其在医药研发服务领域强大竞 争力与行业领先地位。 NO.2 派格生物通过港交所聆讯即将上市，8轮融资估值40亿 派格生物近日通过聆讯，拟在香港主板上市，独家保荐人为中金。公司是自主研究及开发慢性疾病创新 疗法的生物技术公司。2024年收入0.07亿元，净亏损2.83亿元。 点评：派格生物通过港交所聆讯，即将登陆港股。其专注慢性疾病创新疗法，虽目前亏损，但核心产品 潜力大，8轮融资获40亿估值，上市后有望借资本加速发展。 NO.3 德国默克将以39亿美元收购SpringWorks 4月28日，德国默克宣布，将收购SpringWorks，交易代价约为39亿美元的股权价值，或根据 SpringWorks截至2024年12月31日的现金余额计算的34亿美元企业价值。 点 ...