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].

云顶新耀 20250613 摘要 中国 IgA 肾病患者基数庞大，诊断明确者超 100 万，潜在市场规模超 2,500 亿元。耐赋康适应症扩大，取消蛋白尿 1.5mg 限制，并获指南 更新，显著提升其市场潜力。 耐赋康作为首个获批的 IgA 肾病药物，通过临床数据改写 KDIGO 和中 国指南，从对症治疗转变为对因与对症结合，降低蛋白尿、改善肾功能， 并减少致病性 IgA 的形成。 EVER001 作为 PDK 抑制剂，完成 Phase 1 和 Phase 2a 临床试验，数 据展现卓越疗效，适应症扩展至膜性肾病、微小病变型肾炎等免疫性疾 病，未来发展潜力巨大。 耐赋康最新临床证据支持对应、尽早、全部和长期治疗策略。真实世界 研究表明，早期使用耐赋康能显著降低蛋白尿，改善肾功能，且 GD- IgA 等生物标志物可能成为疾病预测工具。 APPLE 001（BTK 抑制剂）在原发性膜性肾病 1B/2A 期临床研究中显 示出良好的安全性和疗效，PLA2R 抗体水平显著下降，蛋白尿降低，有 望成为首个口服治疗该疾病的药物。 Q&A 云顶新耀在 2025 年欧洲肾脏病协会(ERA)大会上展示了哪些重要数据？ 在 202 ...

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 ...

在近日举行的第62届欧洲肾脏协会大会（ERA 2025）上，全球首个对因治疗药物耐赋康®（布地奈德 肠溶胶囊）陆续展示9项最新研究成果，其中最新两项研究证实，耐赋康®显著降低致病因子水平，对 于国际公认的IgA肾病发病机制"四重打击"学说中的第一、第三和第四重打击均有积极调节作用，并发 现Gd-IgA1或多聚IgA最初两个月内的变化与降蛋白尿效果具有相关性，为"对因治疗"策略提供了坚实 支持。其从源头干预发病机制，延缓疾病进展并保护肾功能的临床价值得到进一步验证，为国内外IgA 肾病治疗理念的变革和指南的更新奠定了证据基础。 作为全球首个也是目前唯一在中国、美国和欧洲获得完全批准，且不受蛋白尿水平限制的IgA肾病对因 治疗药物，耐赋康®先后获得了《2024版KDIGO IgA肾病和IgA血管炎临床管理实践指南（公开审查 版）》以及2025版《中国成人IgA肾病及IgA血管炎临床实践指南（预审版本）》国内外指南推荐。 指南预审版还强调了"对因治疗、尽早治疗、全部治疗"的新管理策略。耐赋康®此次在大会上公布的多 项研究结果，为这一新管理策略提供了坚实的科学依据和临床支持，助推IgA肾病治疗水平不断提升。 IgA肾 ...

Core Insights - The recent ERA 2025 conference showcased nine new studies on the drug Nefukang® (Budesonide enteric-coated capsules), confirming its renal protective value for patients with varying baseline eGFR levels and different pathological changes [1][2][3] - Nefukang® is the first and only approved drug for the treatment of IgA nephropathy in China, the US, and Europe, without restrictions based on proteinuria levels, establishing its leadership in first-line treatment [1][4] - The studies support a "total treatment" strategy, emphasizing the importance of early intervention with Nefukang® to protect renal function and improve overall prognosis for all diagnosed patients [1][3] Study Findings - A sub-analysis of the NefIgArd study indicated that treatment with Budesonide enteric-coated capsules for nine months led to reduced proteinuria and stable renal function (eGFR) across all baseline eGFR levels during a two-year study period [2] - Another multi-center study showed significant reductions in proteinuria and stable eGFR in patients with active lesions, particularly those with endothelial cell proliferation and/or crescent formation [2][3] - The findings provide strong evidence for the application of Budesonide enteric-coated capsules in treating IgA nephropathy, offering new treatment options for clinicians [2][3] Clinical Implications - Clinicians are encouraged to initiate cause-specific treatment immediately upon diagnosis to maximize renal function protection and improve patient outcomes [3] - The CEO of Yunding Xinyao highlighted that these studies further validate Nefukang®'s benefits across different renal function levels and pathological types, supporting a new disease management strategy for IgA nephropathy [3] - The prevalence of IgA nephropathy is significantly higher in Asia, with an estimated 5 million patients in China and over 100,000 new cases annually, indicating a substantial unmet clinical need [3] Additional Research - Besides the two key studies, seven other studies presented at the conference covered efficacy prediction markers, treatment sustainability, and safety mechanisms, broadening the applicability of Nefukang® in clinical settings [4] - Nefukang® was included in the national medical insurance drug list as of November 2024, with expectations to leverage its evidence-based advantages to enhance treatment initiation upon diagnosis [4]

Core Insights - The latest research confirms that Nefecon® significantly reduces kidney function deterioration by 50% through its positive effects on the first three hits in the "four-hit" model of IgA nephropathy [1][3][4]. Group 1: Efficacy and Mechanism - Nefecon® has been shown to significantly lower levels of Gd-IgA1, IgG anti-IgA antibodies, and IgA immune complexes (IgA-IC), indicating its effectiveness across multiple pathogenic pathways [1][3][4]. - Changes in Gd-IgA1 or polymeric IgA within the first two months of treatment are significantly correlated with reductions in proteinuria, suggesting these biomarkers could guide Nefecon® therapy [1][3][7]. - The NefIgArd trial involved 216 participants and demonstrated that Nefecon® effectively targets the gut to modulate immune responses, thereby reducing pathogenic IgA levels [4][5]. Group 2: Clinical Significance - Nefecon® is the first and only drug approved for the causal treatment of IgA nephropathy in China, the U.S., and Europe, and is recommended in multiple clinical guidelines, solidifying its position as a cornerstone therapy [2][4]. - The drug's ability to intervene at the source of IgA nephropathy's pathogenesis is expected to reshape treatment strategies and provide more options for a broader patient population [4]. Group 3: Patient Impact - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new cases diagnosed annually, highlighting the significant healthcare burden and the need for effective treatments like Nefecon® [3].

第二项多中心研究聚焦分析伴不同病理表现的IgA肾病患者的治疗获益。结果显示，给予9个月的耐赋 康治疗后患者尿蛋白显著降低，肾功能（eGFR）保持稳定，且在伴有毛细血管内皮细胞增生（E1）和/ 或新月体形成（C1）的患者中，蛋白尿下降更显著。这一发现提示，这两种活动性病变可以积极使用 耐赋康治疗，且无论有无活动性病变，患者均可从治疗中维持eGFR稳定，保护肾功能。 在第62届欧洲肾脏协会（ERA 2025）大会上，耐赋康（布地奈德肠溶胶囊，NEFECON®）展示的两项 最新研究结果证实了耐赋康在不同基线肾功能水平患者中均取得卓越疗效，并揭示了其在全部不同病理 人群中的显著获益。作为全球首个且唯一在中国、美国和欧洲获得完全批准，且不受蛋白尿水平限制的 IgA肾病对因治疗药物，此次研究成果为"全部治疗"策略提供了坚实支持，证实耐赋康实现了IgA肾病全 人群肾脏保护。 耐赋康凭借创新的作用机制和临床优势，先后被纳入改善全球肾脏病预后组织（KDIGO）发布的 《2024版KDIGO IgA肾病和IgA血管炎临床管理实践指南（公开审查版）》，以及《中国成人IgA肾病 及IgA血管炎临床实践指南（预审版本）》。 两项研究证 ...