上市公司如何平衡好经营的可持续性与未来性？ 日前，在云顶新耀医药科技有限公司(以下简称"云顶新耀")的mRNA(信使核糖核酸)创新技术平台研发 日上，云顶新耀首席执行官罗永庆对《证券日报》记者表示，通过"授权引进+自主研发"的双轮驱动战 略，云顶新耀逐渐实现了这一平衡。 具体来看，在经营层面，云顶新耀以引进的大单品实现了较为稳定的现金流；在布局创新上，公司通过 聚焦mRNA疗法等前沿技术，陆续产出了一些成果。罗永庆表示，基于mRNA创新技术平台，云顶新耀 已开发了通用型现货肿瘤治疗性疫苗EVM14、个性化肿瘤治疗性疫苗EVM16、自体生成CAR-T(嵌合抗 原受体T细胞免疫疗法)三款核心产品管线。"公司已与全球排名前20的药企广泛接洽，未来将通过与国 际伙伴合作，推动这些创新成果走向全球市场。" 夯实竞争优势 彻底治愈肿瘤是许多生命科学家的梦想。然而，现有的治疗技术难以在人体内建立起持久的免疫记忆， 因此对降低肿瘤复发率的作用有限。通过改造mRNA，却有可能取得突破。 "mRNA疗法借由基因编辑技术，改造细胞内负责传递遗传指令的mRNA，进而让细胞生产出特定的蛋 白质，可用于治疗肿瘤、传染病、自身免疫性疾病等 ...

Core Insights - The article highlights the advancements of CloudTop New Medicine (1952.HK) in the mRNA technology platform, showcasing its dual-driven strategy that combines cash flow from licensed products with long-term value creation through self-developed mRNA platforms [1][7]. AI Empowerment and Global Competitive Barriers - The latest research indicates that mRNA vaccines have the potential to induce immune memory, effectively preventing tumor recurrence and metastasis [2]. - CloudTop has developed an AI-driven system, EVER-NEO-1, which outperforms international peers in identifying tumor neoantigens, demonstrating superior predictive capabilities [3]. - The company has established a proprietary LNP (lipid nanoparticle) delivery technology platform, with over 500 proprietary lipids, ensuring effective and safe delivery of mRNA therapies [3]. Tumor Treatment Matrix - CloudTop has created a comprehensive tumor treatment matrix that includes personalized mRNA vaccines, off-the-shelf vaccines, and autologous CAR-T therapies [4]. - The EVM16 personalized mRNA vaccine has shown efficacy in preclinical models and is currently in clinical trials, with promising initial results [4]. - The EVM14 off-the-shelf vaccine targets five tumor-associated antigens and is set to begin a global multi-center Phase I clinical trial [5]. Strategic Transformation and Dual-Driven Strategy - The mRNA breakthroughs signify a strategic transformation for CloudTop, moving from a drug commercialization entity to a technology-driven innovative pharmaceutical company [7]. - The company has established a commercial matrix with three key licensed products, expected to generate peak sales of 1.5 billion, 5 billion, and 5 billion respectively, providing a stable cash flow for long-term investments in mRNA technology [7]. - CloudTop's mRNA platform has attracted interest from top global pharmaceutical companies, enhancing its international collaboration and commercialization prospects [8].

6月25日，港股创新药企云顶新耀（1952.HK）宣布，其伊曲莫德（VELSIPITY）用于治疗中重度活动 性溃疡性结肠炎（UC）患者的新药上市许可申请（NDA）正式获得韩国食品药品安全部（MFDS）受 理。这表明该潜力新药在亚洲市场准入方面取得关键进展，其亚洲商业化布局得以进一步完善。此前， 伊曲莫德已在中国澳门、新加坡和中国香港获批，且在中国大陆的上市申请已获受理，此次韩国上市申 请获受理，使得云顶新耀距离亚洲市场全面布局更近一步。 临床数据亮眼 填补百万患者市场空白 此外，云顶新耀在亚洲地区（包括中国大陆、中国台湾和韩国）开展的伊曲莫德多中心、随机、双盲、 安慰剂对照III期研究，更是为在亚洲UC患者中的应用提供了强有力的证据支持。 这项迄今为止完成的最大规模的亚洲中重度溃疡性结肠炎的III期注册临床研究，总计纳入340名中重度 溃疡性结肠炎患者随机接受伊曲莫德或安慰剂治疗。结果显示，每日一片2mg伊曲莫德治疗，所有主要 终点和次要终点均达到显著统计学意义改善，其中52周黏膜愈合率(ES≤1且Geboes <2.0)高达52%，黏膜 完全正常化（ES=0）高达46%。。 溃疡性结肠炎被世界卫生组织列为" ...

Core Viewpoint - The article highlights the rapid growth of China's innovative pharmaceutical companies, particularly in the context of supportive government policies and the increasing commercialization of their products, exemplified by the strategic shift of CloudTop New Horizon towards self-developed mRNA technology and its potential for global expansion [1][12]. Group 1: Policy Support and Market Dynamics - Recent government policies, including the State Council's approval of the "Full Chain Support for Innovative Drug Development Implementation Plan," have significantly boosted the innovative drug sector in China [1]. - In Q1 2025, the "License-out" transaction amount for Chinese innovative drugs reached $36.929 billion, indicating a surge in outbound transactions [1]. Group 2: CloudTop New Horizon's Strategic Shift - CloudTop New Horizon is transitioning from a "License-in" model to a self-developed innovative drug company, marking a significant strategic transformation [1][12]. - The company will hold its first mRNA technology platform R&D day on June 27, showcasing its self-research capabilities and signaling a potential value release [1]. Group 3: Commercialization and Revenue Projections - CloudTop New Horizon has successfully commercialized several key products, including Nefukang® and Yijia®, with projected sales reaching 10 billion yuan by 2030 [2][3]. - Nefukang® has seen a significant increase in sales following its inclusion in the medical insurance system, with expectations for revenue to double in the second half of the year [3][4]. Group 4: Product Pipeline and Market Potential - The company anticipates that Nefukang® could achieve peak sales of 5 billion yuan, while Yijia® is expected to reach similar sales figures due to its potential in the ulcerative colitis market [4][5][6]. - CloudTop New Horizon's product matrix, including Nefukang®, Yijia®, and the pipeline product Cefepime-Tazobactam, is projected to exceed 10 billion yuan in sales by 2030 [6]. Group 5: mRNA Platform Development - The mRNA platform is gaining attention from multinational pharmaceutical companies, with potential business development (BD) collaborations on the horizon [7][12]. - The company has developed a diverse pipeline within its mRNA platform, including personalized tumor therapeutic vaccines and CAR-T therapies, which are expected to attract further investment and partnerships [8][9]. Group 6: EVER001 Clinical Data and Global Expansion - EVER001, a new generation covalent reversible BTK inhibitor, has shown promising clinical data, with plans for global development and potential overseas licensing agreements [10][12]. - The positive clinical results for EVER001 in treating primary membranous nephropathy have garnered interest from multiple multinational pharmaceutical companies, indicating a strong market potential [11][12].

西南证券发布研报称，随着耐赋康、依嘉、伊曲莫德、EVER001等产品的上市和放量，预计云顶新耀 (01952)2025-2027年营业收入分别为14.7、30.7和42亿元。耐赋康是中国首个且唯一获批的IgA肾病治疗 药物，上市后放量明显，销售峰值预计达到50亿元；伊曲莫德为新一代口服治疗溃疡性结肠炎药物，有 望于2025年底前获批上市；EVER001为共价可逆BTK抑制剂，潜在同类最佳产品，授权潜力大。 伊曲莫德为新一代口服治疗溃疡性结肠炎药物，销售峰值有望达20亿元。我国溃疡性结肠炎近几年发病 率有上升趋势，到2030年我国溃疡性结肠炎患者人数预计将达到91.8万人。伊曲莫德为新一代口服治疗 溃疡性结肠炎药物，其亚洲多中心Ⅲ期临床研究完整维持期数据在第20届欧洲克罗恩病和结肠炎组织年 会(ECCO2025)公布，结果显示，伊曲莫德组有89.6%的患者完成了40周维持期，显著高于安慰剂组的 51.9%。 EVER001凸显BIC潜力，出海潜力大。EVER001胶囊是新一代共价可逆的布鲁顿酪氨酸激酶(BTK)抑制 剂。与共价和不可逆BTK抑制剂相比，EVER001作为一款潜在的同类最佳产品，在保持高效的同时具 ...

港股创新药迎来翻盘时刻。创新药板块已成为今年以来港股市场中股价翻倍最多的板块。 "这波行情来得突然，机器人AI研究员群里都开始讨论创新药了。"华南某一级行业投资经理向21世纪经 济报道记者说道。 据21世纪经济报道记者不完全统计，截至目前港股有20余只创新药相关股票年内涨幅超过或接近 100%，其中有6只年内涨幅超过2倍，另有近10只接近翻倍。多只个股开启短期翻倍式飙涨，持续引爆 全市场的热情。 不过值得注意的是，截至5日收盘，股价高于发行价的企业为科伦博泰、信达生物、康方生物、映恩生 物，较发行价涨幅分别为447.6% 、417.1%、406.5%、 116.8%。其中复宏汉霖5日收盘价45.45港元/股略 低于发行价49.6港元/股。 值得一提的是，此前复星医药拟以不超过约54.07亿港元，低于发行价一半价格私有化复宏汉霖，但最 终搁浅。 截至6月5日收盘，德琪医药、和铂医药、加科思年内涨幅均超300%，分别为467.69%、324.19%、 305.51%，堃博医疗、荣昌生物年内涨幅也超200%，不过除荣昌生物低于发行价9.21%外，其他各股仍 大幅度远低于发行价。 2018年4月，香港联合交易所在《主 ...

Core Insights - The company, CloudTop New Drug-B (01952), has achieved significant growth in the innovative drug market, with a revenue increase of 461.16% year-on-year, reaching 707 million yuan in 2024, marking its first successful financial year and indicating a potential transition to a new stage of maturity [1][2] - The dual strategy of "independent research and development + authorized introduction" has allowed the company to target high-potential, low-competition areas, leading to efficient commercialization of differentiated innovative results [1][2] - The successful commercialization of key products, such as NAIFUKANG® and YIJIA®, has been crucial for the company's growth, with both products generating significant sales revenue shortly after their market introduction [2][3] Financial Performance - In 2024, the company reported a revenue of 707 million yuan, a substantial increase of 461.16% compared to the previous year [1] - NAIFUKANG® generated 353 million yuan in sales within just seven months of its launch, while YIJIA® achieved sales of 353 million yuan in 2024, reflecting a year-on-year growth of 256% [2] Product Development - The company is advancing its pipeline with key products like Yiqiumode, which is expected to reach peak sales of 2 billion yuan and is anticipated to be a significant part of the product line [3] - The company is also expanding into AI-driven drug development, with its first AI-driven mRNA personalized cancer vaccine, EVM16, completing its first patient dosing, marking a significant step in clinical validation [3] Market Position and Future Outlook - The company is positioned to replicate the success of other 18A companies that have transitioned to maturity, with expectations of continued stock price growth and market recognition [4] - Recent reports have indicated a substantial increase in the company's target price by 133% to 70 HKD, reflecting the market's recognition of its research and development value [4]

一个价值创造样本。 作者 I 周佳丽 报道 I 投资界PEdaily 2 0 2 2年夏末，云顶新耀上海办公室气氛凝固，这天公司正在进行创立以来最沉重的一次 全员大会。 大约半个月前，云顶新耀将几乎撑起市值半壁江山的戈沙妥珠单抗（拓达维®）卖回给了 吉利德。市场情绪激烈，云顶新耀股价一路下挫，一度跌破6港元/股。 "今天，肿瘤团队将全部遣散。"会议大屏的另一端，远在新加坡出差的董事局主席傅唯 郑重表示。这是一个艰难的决定。虽然肿瘤团队表现卓越，成功推动了云顶新耀历史上第 一个1 .1类创新药的高效审批，但为了确保整个平台的长期发展，傅唯不得不作出"牺牲肿 瘤业务"的抉择。 作为云顶新耀的孵化者和控股股东，傅唯率队的康桥资本在这样的关键时刻向所有人宣布 了这一决定。之后，云顶新耀将全面聚焦肾病、重症抗感染、自体免疫、mRNA癌症治 疗疫苗等蓝海领域，追求商业化的极致效率。随着明星CEO罗永庆的加入，云顶新耀开 始新的征程。 彼时，国内生物药企刚刚感到一丝凉意，大家都认为是暂时的调整而已，大多数人并不能 完全理解云顶新耀这一突然转变，质疑声此起彼伏。两年过去，这一决策已经决定了一大 部分云顶的命运走向。这注定是一 ...