中金发表研报指，云顶新耀上半年业绩符合该行预期，收入按年增长48%至4.46亿元。其中耐赋康贡献 收入3.03亿元，按年增长81%。由于终端需求旺盛，中金上调耐赋康今明两年销售预期，调整2026年盈 利预测，由1200万元修订至1.19亿元。该行维持对其"跑赢行业"评级，由于市场开始将公司在研管线出 海预期打入估值，上调目标价10%至88港元。 ...

1H25公布实现收入4.46亿元，同比增长48%，其中耐赋康贡献收入3.03亿元，同比增长81%，依嘉贡献 收入1.43亿元，同比增长6%。耐赋康于今年年初医保价格落地执行，终端需求旺盛，并在2Q末出现了 缺货问题，但公司扩张申请于2025年8月1日顺利获批，正常供货恢复，因此单8月份耐赋康累计实现发 货超13万瓶，1-8月份贡献收入8.25亿元。得益于IgA肾病终端需求旺盛、耐赋康独占医保、公司销售投 入大等因素，公司公告耐赋康2025年销售目标为12-14亿元，同比增长超200%，2026年目标24-26亿元， 同比增长约100%。公司另外一款潜在重磅单品艾曲莫德(商品名：维适平)正处于国内NDA阶段，公司 已提前启动商业化团队搭建，并推动本地化生产项目建设。 关注EVER001和mRNA平台出海进展 在肾病治疗领域，除已上市的耐赋康外，公司也布局了EVER001，其是新一代共价可逆BTK抑制剂， 公司在全球范围内开发治疗膜性肾病，正在进行的Ib/IIa前期原发性模型肾病临床试验获得积极结果， 并具备授权合作潜力。在mRNA肿瘤疫苗领域，个性化肿瘤疫苗EVM16的IIT研究已完成低、中剂量组 爬坡，初步数 ...

1H25公布实现收入4.46亿元，同比增长48%，其中耐赋康贡献收入3.03亿元，同比增长81%，依嘉贡献 收入1.43亿元，同比增长6%。耐赋康于今年年初医保价格落地执行，终端需求旺盛，并在2Q末出现了 缺货问题，但公司扩张申请于2025年8月1日顺利获批，正常供货恢复，因此单8月份耐赋康累计实现发 货超13万瓶，1-8月份贡献收入8.25亿元。得益于IgA肾病终端需求旺盛、耐赋康独占医保、公司销售投 入大等因素，公司公告耐赋康2025年销售目标为12-14亿元，同比增长超200%，2026年目标24-26亿元， 同比增长约100%。公司另外一款潜在重磅单品艾曲莫德(商品名：维适平)正处于国内NDA阶段，公司 已提前启动商业化团队搭建，并推动本地化生产项目建设。 关注EVER001和mRNA平台出海进展 在肾病治疗领域，除已上市的耐赋康外，公司也布局了EVER001，其是新一代共价可逆BTK抑制剂， 公司在全球范围内开发治疗膜性肾病，正在进行的Ib/IIa前期原发性模型肾病临床试验获得积极结果， 并具备授权合作潜力。在mRNA肿瘤疫苗领域，个性化肿瘤疫苗EVM16的IIT研究已完成低、中剂量组 爬坡，初步数 ...

该行看好公司大单品商业化及自研平台双轮驱动长期高成长，目标价由72.5港元上调至84港元，对应2.1 倍收入达峰时市销率，评级"买入"。云顶新耀今年下半年至2026年催化剂丰富，包括艾曲莫在中国获 批、商业化和医保谈判及自研管线BD合作机会，当前估值仍吸引。基于耐赋康强劲销售表现，该行上 调2026至2027年收入预测16%至18%，同时对经营费用率有更乐观的预测。 交银国际发表研究报告指，云顶新耀上半年收入按年增长48%至4.46亿元，其中依嘉和耐赋康销售分别 增长6%及81%至分别1.43亿及3.03亿元。在产能限制解决后，耐赋康8月快速放量，2025年首八个月销 售超该行和市场的预期，管理层相应上调销售指引，体现对产品临床数据和商业化能力的强大信心。 ...

Investment Rating - The report assigns a "Buy" rating to the company, indicating an expectation of total returns exceeding the relevant industry over the next 12 months [3][12]. Core Insights - The company has experienced rapid sales growth following the resolution of capacity constraints, with sales for the first eight months of 2025 exceeding both the report's and market expectations. The management has raised sales guidance, reflecting strong confidence in clinical data and commercialization capabilities [2][7]. - The target price has been raised to HKD 84.00, representing a potential upside of 32.2% from the current price of HKD 63.55 [1][12]. Financial Performance Summary - Revenue for 2025 is projected at RMB 1,611 million, with a significant increase to RMB 2,951 million in 2026 and RMB 4,408 million in 2027, reflecting a growth trajectory [6][13]. - The company reported a net loss of RMB 160 million for 2025, with expectations of turning profitable by 2026 with a net profit of RMB 325 million [6][13]. - The gross profit margin is expected to stabilize around 70% in 2025, improving to 73% in 2026 and 74.5% in 2027 [6][13]. Sales and Market Dynamics - The company’s flagship product, Nanfukang, has seen sales growth of 81% year-on-year, with total sales expected to reach RMB 12-14 billion for the year, and potentially doubling to RMB 24-26 billion in 2026 [7][8]. - The company is also advancing its pipeline with promising clinical data, particularly for its third commercialized product, which is anticipated to achieve peak sales of RMB 5 billion [7][8]. Valuation and Future Outlook - The report utilizes a DCF model to arrive at a target price of HKD 84.00, based on optimistic revenue forecasts and improved operating expense ratios [8][12]. - The company is expected to achieve operational breakeven in the second half of 2025, earlier than previously anticipated [7][8].

云顶新耀 20250829.docx AceCamp AI 2025-08-30 摘要 云顶新耀预计 2025 年总收入达 16-18 亿元人民币，其中耐赋康销售额 预计为 12-14 亿元，有望成为首个纳入医保后首年销售额破 10 亿元的 非肿瘤药物，公司预计下半年实现经营性盈利。 耐赋康市场表现强劲，1-8 月收入达 8.2 亿元，8 月单月收入 5.2 亿元， 预计 2025 年销售额达 12-14 亿元，2026 年达 24-26 亿元，受益于医 保覆盖、患者需求及治疗范围扩大。 公司自主研发平台取得进展，MRNA 自体生成 CAR-T 平台预计 2025 年 底启动临床开发，MRNA 肿瘤疫苗平台多款产品推进中，TAAEV M14 已获美国 IND 批准。 公司财务状况稳健，现金余额 16 亿元人民币，完成 16 亿港币配股融资， 并战略投资 IMAX，持股 16.1%成最大股东。2025 年上半年营收 4.46 亿元，同比增长 48%。 艾曲莫德（维施平）被视为公司第二个重磅产品，针对溃疡性结肠炎， 展现出强效的深度黏膜愈合能力和良好的安全性，预计 2026 年上半年 获批，销售峰值预计 50 亿 ...

Group 1 - The core viewpoint of the articles highlights the strong financial performance and growth prospects of CloudTop New Medicine, with significant revenue increases and a solid cash reserve [1][2] Group 2 - For the first half of 2025, CloudTop New Medicine reported a revenue of 446 million yuan, representing a 48% year-on-year increase, with a gross margin of 76.4% [1] - The company narrowed its non-IFRS losses by 31% compared to the previous year, indicating improved operational efficiency [1] - As of mid-2025, the cash balance reached 1.6 billion yuan, supplemented by recent equity financing of 1.553 billion HKD, bringing total cash reserves to over 2.5 billion yuan [1] Group 3 - In the nephrology treatment sector, the main product, Nefukang, saw a sales revenue of 303 million yuan in the first half of 2025, an 81% increase year-on-year, with cumulative sales reaching 825 million yuan from January to August [1] - The management expects Nefukang's annual sales to exceed 1.2 billion to 1.4 billion yuan, with projections for 2026 indicating potential sales growth to 2.4 billion to 2.6 billion yuan [1] Group 4 - The antibiotic product, Yijia, also showed stable growth, with revenue of 143 million yuan in the first half of 2025, a 6% increase year-on-year, and a 37% increase in direct sales to core hospitals [1] Group 5 - The CEO of CloudTop New Medicine emphasized the success of the "dual-drive" strategy, focusing on high-potential markets and self-developed platforms, which has led to breakthroughs in commercialization and research [2] - The company is confident in achieving an annual sales target of 1.6 billion to 1.8 billion yuan and expects to turn positive in operating cash flow by the fourth quarter [2]

Group 1 - The company is confident in achieving its annual sales target of 1.6 billion to 1.8 billion yuan, aiming for operational profitability by the second half of 2025 [1][2] - The core product, Nefikastat, has shown exceptional performance with sales revenue of 303 million yuan in the first half of the year, representing an 81% year-on-year increase [1] - As of August, the sales team in the nephrology sector has expanded to 190 members, covering 1,000 target hospitals, with approximately 30,000 new patients expected by the first half of 2025 [1] Group 2 - The company reported a revenue of 446 million yuan for the first half of 2025, a 48% year-on-year increase, with a gross margin of 76.4% [4] - The non-IFRS loss has narrowed by 31% year-on-year, indicating a continued approach towards profitability [4] - The cash balance at the end of the first half reached 1.6 billion yuan, supplemented by recent fundraising of 1.553 billion HKD, bringing total cash reserves to over 2.5 billion yuan [4] Group 3 - The company is focusing on its self-developed core pipeline and accelerating the clinical development and internationalization of global rights products [1] - The product pipeline includes personalized tumor therapeutic vaccines, mRNA tumor therapeutic vaccines, and self-generated CAR-T projects [2] - The CEO emphasized the dual-driven strategy to establish a commercial platform for high-potential markets and to advance the self-generated CAR-T and mRNA vaccine platforms [2]

Core Viewpoint - CloudTop New Drug (1952.HK) reported a strong performance in its 2025 interim results, with a revenue increase of 48% year-on-year, driven by its core product, Nefukang, which is expected to achieve significant sales growth in the coming years [1][2][4]. Financial Performance - The company achieved a revenue of 446 million RMB, with a gross margin of 76.4% after excluding non-cash items [1]. - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, and the total loss under non-IFRS standards narrowed by 31% [1]. - Cash reserves stood at 1.6 billion RMB, bolstered by a recent fundraising of approximately 1.553 billion HKD [1]. Product Performance - Nefukang, a treatment for IgA nephropathy, generated sales of 825 million RMB from January to August, with August sales alone reaching 520 million RMB [2][3]. - The company anticipates Nefukang's annual sales to reach between 1.2 billion and 1.4 billion RMB, with projections for 2026 sales between 2.4 billion and 2.6 billion RMB [2][3]. - The product is the only IgA nephropathy drug included in the medical insurance system across 29 provinces, significantly enhancing patient accessibility [3]. Market Potential - The market for IgA nephropathy treatment is substantial, with over 5 million patients in China and 1 million diagnosed cases [3]. - The company has expanded its nephrology sales team to 160 members to meet growing demand and has received approval for production capacity expansion [3]. R&D Progress - The company has made significant advancements in its self-developed pipeline, particularly in mRNA cancer therapeutic vaccines and CAR-T platforms [4]. - The personalized tumor therapeutic vaccine EVM16 has initiated its first human clinical trial in China, with positive preliminary data [4]. - The universal tumor therapeutic vaccine EVM14 has received FDA approval for clinical trials, with patient enrollment expected to begin by September 2025 [4]. Strategic Developments - The company successfully removed the "B" mark from its Hong Kong stock, reflecting market confidence in its R&D pipeline and commercialization capabilities [7]. - A recent fundraising effort raised approximately 1.5725 billion HKD, indicating strong interest from international long-term funds [7]. - The company has increased its stake in I-Mab to 16.1%, becoming its largest shareholder, which complements its mRNA vaccine and CAR-T pipeline [7]. Future Outlook - The company aims to leverage its dual-driven strategy focusing on Nefukang and VisiPing as key products, with projected peak sales exceeding 25 billion RMB [8]. - The integration of AI and mRNA technology platforms is expected to drive early-stage R&D and internationalization efforts [8].

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [12][14] - Revenue from Nephicon alone reached RMB 520 million in August, indicating a strong recovery from earlier supply issues [13] - Full year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [13][14] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [14] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [14] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August, with strong market demand leading to a significant uptick in sales after regulatory approval [4][5] - The autoimmune disease franchise, particularly Velsipiti, is progressing well with NDA reviews and expected early 2026 approval [7][8] - XERAVA in the anti-infective segment showed steady growth, with revenue increasing by 37% year-over-year [23] Market Data and Key Metrics Changes - The company aims to expand Nephicon's market coverage to 1,000 hospitals, targeting approximately 30,000 new patients [18][20] - The estimated market for IgAN in China includes about 5 million patients, with significant growth potential as the company expands its reach [19][20] - The ulcerative colitis market is projected to grow, with peak sales for Velsipiti expected to reach RMB 5 billion [34] Company Strategy and Development Direction - The company is focused on a dual strategy of commercialization and in-house discovery, with significant investments in R&D to support long-term growth [35][72] - Plans include localizing production for various products and preparing for NRDL negotiations to enhance market access [72] - The company is also exploring partnerships and in-licensing opportunities to bolster its product pipeline and market presence [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving operational profitability earlier than previously guided, now targeting Q4 2025 [15] - The company is optimistic about the upcoming regulatory approvals and market launches, which are expected to drive revenue growth [71][72] - Management highlighted the strong clinical data supporting their products, which positions them favorably in the market [82] Other Important Information - The company completed a strategic investment of USD 30.9 million in I Mab, becoming the largest shareholder with a 16.1% stake [12][70] - The company is advancing its proprietary mRNA technology platform, which is expected to enhance its R&D capabilities and product offerings [48][49] Q&A Session Summary Question: Peak sales for Etrasimod - Management noted that the potential for Etrasimod is higher than previously stated due to strong clinical data and an underdeveloped market, with preparations underway for commercial launch [80][82][86] Question: Development plans for EVER-one - Management confirmed that they are in the design stage for pivotal trials and are planning to initiate these studies in 2026, with ongoing discussions for potential partnerships [89][90][92]