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].

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].

5月7日，港股创新药企云顶新耀（HKEX 1952.HK）宣布，耐赋康®（布地奈德肠溶胶囊）正式获得国家药品监督管理局（NMPA）同意，由附条件批准 转为完全批准，用于治疗具有疾病进展风险的原发性免疫球蛋白A肾病（IgAN）成人患者，以减少肾功能损失。作为中国唯一获得IgA肾病适应症的治疗 药物，耐赋康®临床研究的完整数据已获通过，成为国内首个且唯一获得NMPA完全批准的IgA肾病对因治疗药物，进一步夯实其一线治疗的基石地位。 据悉，IgA肾病在是最常见的原发性肾小球肾炎，也是导致肾功能衰竭的重要原因之一。此次获批是基于NefIgArd Ⅲ期临床研究2年完整优异的肾功能保 护数据，这将极大扩展耐赋康®用药患者基数，促使更广泛的患者获益。全球IgA肾病权威指南《2024版KDIGO IgA肾病和IgA血管炎临床管理实践指南 （公开审查版）》也在提及目前可用治疗方案的主要优势时指出，耐赋康®是迄今为止唯一被证明可以降低IgA和IgA免疫复合物水平的治疗方法。 据悉，作为全球首个同时获美国食品药品监督管理局和欧洲药品管理局完全批准的IgA肾病治疗药物，耐赋康®是靶向肠道黏膜B细胞的免疫调节剂，专为 IgA肾病患者研 ...

5月7日，港股创新药企云顶新耀（01952）宣布，耐赋康®（布地奈德肠溶胶囊）正式获得国家药品监 督管理局（NMPA）同意，由附条件批准转为完全批准，用于治疗具有疾病进展风险的原发性免疫球蛋 白A肾病（IgAN）成人患者，以减少肾功能损失。新适应症夯实了耐赋康治疗 IgA 肾病一线基石地 位，此次完全批准意味着耐赋康®临床研究的完整数据已获通过，成为国内首个且唯一获得NMPA完全 批准的IgA肾病对因治疗药物。 云顶新耀首席执行官罗永庆表示："此次完全批准取消了对蛋白尿水平的限制，这将推动耐赋康®从改 变治疗格局走向重塑治疗标准，延缓IgA肾病患者肾功能衰退，更好地满足长期未被满足的临床需求， 使更多患者获益。新适应症的获批充分验证了耐赋康®的临床疗效与安全性，为医生提供了更加坚实的 治疗决策依据，使其成为了中国首个且目前唯一获得NMPA完全批准的IgA肾病对因治疗药物。" 耐赋康®在获得完全批准后，其适用人群将大幅扩展，随着临床需求激增，医保逐步放量、权威指南的 推荐以及海外市场的加速拓展，多重因素共同推动其市场渗透力和销售增长。作为一款具有显著临床价 值的创新药物，耐赋康®的普及不仅将优化患者治疗路径，也 ...

近年来，在国内创新药市场加速改革的机遇下，云顶新耀-B(01952)依托强劲的创新药与AI制药的自主 研发实力，辅以外部授权引进合作，以"双轮驱动"的姿态全面加速创新，取得创新发展上质的飞跃。 2024年财报的亮眼表现，不仅标志着公司首次实现，更预示着其即将迈入"摘B"新阶段。 财报显示，2024年，云顶新耀实现营业收入7.07亿元，同比激增461.16%。根据港交所《上市规则》第 8.05(3)条，若企业满足"市值至少40亿港元且最近财年收益不低于5亿港元"的条件，即可移除"-B"标 记。云顶新耀显然已全面达标，成为港股市场又一家迈向成熟Biopharma的创新药企。 智通财经APP认为，近年来，在"自主研发+授权引进"双轮驱动策略下，云顶新耀瞄准高潜力、低竞争 赛道，快速实现了差异化创新成果的商业化高效转化，这便是云顶新耀能够迅速高效达成18A"摘B"里 程碑的重要原因。 得益于自身独特的商业洞见，云顶新耀以较低代价在较早阶段在IgA肾病治疗领域和抗生素领域分别引 进了核心品种耐赋康®及依嘉®(依拉环素)。 以耐赋康®为例，去年5月，在公司高效推动下，耐赋康®成功在中国大陆获批上市，并在同年进入国 家医保 ...

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 ...