交银国际研究 每日晨报 2025 年 7 月 3 日 今日焦点 | 北方华创 | | 002371 CH | | --- | --- | --- | | 国产半导体设备龙头：成长性与韧性兼备，首 | | 评级: 买入 | | 予买入 | | | | 收盘价: 人民币 443.30 | 目标价: 人民币 530.00 | 潜在涨幅: +19.6% | | 王大卫, PhD, CFA | Dawei.wang@bocomgroup.com | | 半导体行业国产替代最核心的环节：正如之前主题报告中所提到的，我 们看好国产半导体设备行业前景，并关注龙头公司北方华创。 下游需求持续旺盛，国产设备市占率提升：中国内地半导体设备市场在 全球市场的份额从 2015 年的 13%升至 2024 年的 42%。在这个过程中， 北方华创业绩在上行周期中表现出高成长性，在下行周期中韧性较强。 与市场一致预测同比下降不同，我们预测中国内地 2025 年市场将保持增 长，达 500 亿美元。进口设备占比呈下降趋势，我们估算从 2015 年的 91.8%到 2024 年的 67.6%。我们预测北方华创 2025 年在内地半导体设备 市场 ...

AI + mRNA 技术平台亮相研发日：公司近期举办研发日活动，集中展示其完全整合且本地化的AI + mRNA 平台，及基于该平台的多款mRNA 肿瘤药物研发进展：1）个性化肿瘤治疗性疫苗EVM16 目前 已在小鼠黑色素瘤模型中验证疗效并展现出与PD-1 抗体存在协同作用。其IIT 研究的初步结果显示，即 使低起始剂量，也能在晚期肿瘤患者中激发特异性T 细胞反应，具有良好的免疫原性。2）通用型现货 肿瘤治疗性疫苗EVM14 同时靶向5种肿瘤相关抗原，适用于多种鳞癌，临床前研究发现其具备诱导免疫 记忆、降低肿瘤复发的潜力，正同步推进中美双报。3）自体生成CAR-T 项目也已在动物模型中验证有 效，具备现货型、无需淋巴耗竭、剂量可控等优势，展现了开发用于肿瘤及自身免疫疾病的潜力。 可逆BTK 治疗膜性肾病更新优异数据：公司公布了共价可逆BTK 抑制剂EVER001 治疗膜性肾病的 Ib/IIa 期数据。试验招募抗PLA2R 自抗体阳性的患者，分为低剂量组（100mg QD x 4 周 + 100mg BID x 32 周）和高剂量组（200mg BID x 36 周），36 周治疗后接受16 周随访。结果显示：1 ...

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 | 买入 | | | | --- | --- | --- | | 1 | 年股价表现 | | | 250% | 1952 HK | 恒生指数 | | 200% | | | | 150% | | | | 100% | | | | 50% | | | | 0% -50% | | | 股份资料 交银国际研究 公司更新 | 医药 | 收盘价 | 目标价 | 潜在涨幅 | 2025 年 7 月 2 日 | | --- | --- | --- | --- | --- | | 62.20 | 港元 | 港元 72.50↑ | +16.6% | | | 云顶新耀 (1952 HK) | | | | | | 52周高位 (港元) | 65.15 | | --- | --- | | 52周低位 (港元) | 18.28 | | 市值 (百万港元) | 20,198.83 | | 日均成交量 (百万) | 13.36 | | 年初至今变化 (%) | 28.51 | | 200天平均价 (港元) | 47.94 | | 资料来源 : FactSet | | 丁 ...

Core Viewpoint - The latest phase data from the 1b/2a clinical trial of EVER001 shows promising efficacy and safety in treating primary membranous nephropathy (pMN), supporting its potential as a treatment for autoimmune glomerular diseases characterized by proteinuria [2][3][4]. Group 1: Clinical Trial Results - As of March 21, 2025, the ongoing 1b/2a clinical trial has collected long-term data, with 11 patients in the low-dose group followed for 52 weeks, and 16 and 12 patients in the high-dose group completing 24 and 36 weeks of treatment, respectively [1][3]. - The geometric mean levels of anti-PLA2R antibodies decreased by 62.2% and 87.3% in the low and high-dose groups at 12 weeks, with both groups showing over 93% reduction at 24 weeks [1][3]. - The 24-hour proteinuria geometric mean values decreased by 57.0% and 67.6% at 24 weeks for the low and high-dose groups, respectively, with further reductions to 76.7% and 80.6% at 36 weeks, maintained until the 52-week follow-up [4][5]. Group 2: Safety and Tolerability - EVER001 demonstrated good safety and tolerability, with most adverse events being mild to moderate and transient, consistent with previous observations [1][3][6]. - No clinically significant adverse events commonly associated with other BTK inhibitors, such as bleeding or severe infections, were observed [3][6]. Group 3: Market Potential and Future Development - The company aims to accelerate the global clinical development of EVER001, which has the potential to address the unmet medical needs of over 10 million patients with pMN and other autoimmune kidney diseases [5][15]. - Currently, there are no approved drugs for the treatment of pMN globally, highlighting the significant market opportunity for EVER001 [4][6]. - The company plans to initiate Phase 3 clinical trials and engage with regulatory authorities in the U.S. and China to expedite the development process [6][17]. Group 4: Mechanism and Advantages - EVER001 is a next-generation covalent reversible BTK inhibitor, offering advantages such as better selectivity and reduced off-target toxicity compared to traditional irreversible BTK inhibitors [5][13]. - The drug's mechanism allows for rapid and sustained immune and clinical responses, with significant reductions in antibody levels and proteinuria observed early in treatment [11][12][13]. Group 5: Broader Applications - The company believes that EVER001 may also be effective for other autoimmune diseases, including IgA nephropathy and lupus nephritis, due to its mechanism of action [15][18]. - There is a significant unmet need in these conditions, with millions of patients potentially benefiting from this treatment [15][18].

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 ...

Core Insights - There are currently no approved drugs for the treatment of primary membranous nephropathy globally [1] - The emergence of small molecule targeted BTK inhibitors is leading to a shift towards "chemotherapy-free" treatment options in hematological malignancies [1] - Cloudbreak New Horizon (01952.HK) presented preliminary results of its novel covalent reversible BTK inhibitor EVER001 at the 62nd European Renal Association Congress, showing efficacy and good tolerability in patients with primary membranous nephropathy [1][3] Group 1: Clinical Study Results - The 1b/2a study of EVER001 involved 31 patients with confirmed anti-PLA2R antibody-positive primary membranous nephropathy, divided into low-dose and high-dose groups, treated for 36 weeks [3] - At the 24-week mark, both low-dose and high-dose groups showed a 93% reduction in anti-PLA2R antibodies, with complete immunological remission rates of 76.9% and 81.8% respectively [3] - Proteinuria levels decreased by 78.0% in the low-dose group at 36 weeks (maintained to 52 weeks) and by 70.1% in the high-dose group at 24 weeks, with 80% of patients achieving clinical remission [3] Group 2: Market Context and Future Plans - Currently, five BTK inhibitors have been approved in China, with three imported and two domestic, primarily focusing on the hematological malignancy market, which is becoming increasingly competitive [4] - The company plans to accelerate the global clinical development of EVER001 and explore indications for IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis [4] - There are potential plans for global market expansion and licensing collaborations for EVER001 in the future [4]

其中，EVER001治疗原发性膜性肾病的1b/2a期临床试验最新阶段性数据显示，EVER001高低两个剂量 组都取得了高临床缓解率，且总体安全性和耐受性良好，未观察到在其他共价非可逆BTK抑制剂上常见 的有临床意义的不良事件。这些结果支持EVER001具有治疗以蛋白尿为特征的自身免疫性肾小球疾病 的潜力，而全球超过1000万的患者群体，也预示着EVER001未来有望成为又一款重磅肾科药物。 耐赋康9项最新研究则显示，作为全球首个且唯一完全获批IgA肾病适应症的对因治疗药物，其全面支 持"对因治疗、尽早治疗、全部治疗"的IgA肾病新管理策略，其IgA肾病一线基石治疗的领导地位得到了 进一步巩固，从改变IgA肾病治疗格局走向重塑治疗标准。 EVER001临床试验结果首秀 据云顶新耀6月9日官微的消息，此届大会上，公司新型BTK抑制剂EVER001的1b/2a期临床试验积极结 果首次亮相。这款药物对于原发性膜性肾病的治疗展现出独特优势，为该疾病治疗困境带来全新曙光。 据悉，原发性膜性肾病作为仅次于IgA肾病的原发性肾小球肾炎，全球患者数量庞大。仅我国就约有 200万患者，而欧美和日本约有近22万患者。更为严峻的是， ...

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 ...