当中国创新药进入去同质化、拼体系与拼长期能力的新阶段，不同药企正在探索各自的生存与增长答 案。云顶新耀正尝试通过"BD引进+自主创新"并行的战略布局，构建一条面向全球的长期增长曲线。围 绕肾科、自身免疫、急重症、心血管及眼科等核心领域，公司通过"BD合作+自研"双轮驱动并行推进。 在商业化层面，云顶新耀旗舰产品耐赋康®（Nefecon®）作为全球首个且唯一实现对因治疗的IgA肾病 药物，通过靶向回肠黏膜免疫系统，从发病机制上游干预疾病进展，显著延缓肾功能下降。耐赋康®全 球上市获批是基于一项为期2年、随机、双盲、全球多中心Ⅲ期临床研究（364例患者）的完整数据，该 产品已在中国获完全批准并纳入医保，且同时被《2025 KDIGO IgA 肾病和IgA血管炎临床实践管理指 南》及《中国成人IgA肾病及IgA血管炎临床实践指南（2025）》推荐为"首选对因治疗药物"。 另一确定性大单品维适平®（艾曲莫德）作为新一代高选择性S1P受体调节剂，在中重度溃疡性结肠炎 （UC）中展现出深度黏膜愈合与良好安全性，为治疗UC的Best-in-Disease药物，已被纳入2024年美国 胃肠病学协会（AGA）临床实践指南和《2 ...

EVER001：破局原发性膜性肾病，有望填补对因治疗空白EVER001 是一款针对原发性膜性肾病 （PMN）的新一代共价可逆BTK 抑制剂。该药物通过精准抑制B 细胞信号通路，从源头上减少致病性 自身抗体的产生。其疗效与安全性双优：疗效方面，EVER001 24 周时抗PLA2R 抗体降低超过93%，蛋 白尿缓解率达到80%，血清白蛋白提升27.4%；安全性方面，EVER001 治疗相关不良事件发生率可控， 多数为轻中度。整体来看，PMN 对因治疗药物临床尚属空白，EVER001 有望提供新的临床治疗选择。 艾曲莫德：UC 市场口服新星，黏膜愈合赋能潜力best-in-disease艾曲莫德是一款口服S1P 受体调节剂， 核心推进适应症为中重度UC。UC 在我国患者基数庞大，黏膜愈合已成为核心治疗目标。关键III 期研 究显示，艾曲莫德在诱导期起效迅速（12 周临床缓解率达27%），维持期疗效稳固（52 周临床缓解率 32%），并在亚洲人群中展现出卓越的黏膜愈合能力（52 周黏膜愈合率51.9%），具备best-in-disease 潜 力。其安全性良好，不良事件以轻中度为主，整体与安慰剂相当。艾曲莫德有望以 ...

[Table_scodeMsg1] 港股研究丨公司深度丨云顶新耀（01952.HK） [Table_Title] 云顶新耀深度系列报告（一）：自免肾病龙头 Biopharma，耐赋康+维适平塑造双增长极 %% %% %% %% research.95579.com 1 丨证券研究报告丨 报告要点 [Table_Summary] 云顶新耀是一家专注于创新药和疫苗研发、制造及商业化的生物制药公司。近年来逐步形成了 License-in 引进大单品、自研高门槛管线的双轮驱动格局。作为系列报告的第一篇，本篇报告 将聚焦公司引进的肾病、自免领域的大单品（耐赋康、EVER001、艾曲莫德等）。具体来说， 耐赋康在 IgA 肾病领域临床证据全面，或将成为基石疗法之一；EVER001 有望填补原发性膜 性肾病对因治疗空白；艾曲莫德黏膜愈合优势明确，强势切入中重度 UC 小分子口服药市场。 整体来看，公司重磅品种放量趋势显著，远期空间巨大，将持续夯实公司增长基石。 彭英骐 刘长洪 请阅读最后评级说明和重要声明 2 / 46 %% %% %% %% 分析师及联系人 [Table_Author] SAC：S049052403000 ...

Core Insights - YunTing New Drug's core product, Naisukan (Budesonide enteric-coated capsules), has demonstrated clinical value in the new management strategy for IgA nephropathy, focusing on "etiological treatment, early treatment, and long-term treatment" [1][3] - The drug has shown effectiveness in special populations, including patients with severe renal impairment and children, reinforcing its position as a first-line treatment for IgA nephropathy [1] - The cumulative sales revenue of Naisukan reached nearly 1 billion yuan from January to September this year, marking it as one of the fastest-growing chronic disease innovative drugs in recent years [2] Group 1 - The real-world studies presented at ASN Kidney Week 2025 validate the clinical advantages of Naisukan, with evidence supporting its efficacy in early treatment for patients with proteinuria levels below 0.5g/d [1][2] - The introduction of Naisukan into the National Medical Insurance Directory in 2024 is expected to activate clinical demand significantly, with the reimbursement policy effective from January 1, 2025 [2] - YunTing New Drug is developing diagnostic testing reagents for IgA nephropathy, which are expected to fill the gap in non-invasive diagnosis in China, potentially replacing kidney biopsy as an auxiliary diagnostic method [2] Group 2 - The company anticipates that the deepening of clinical consensus and insurance coverage will enhance the market penetration of Naisukan, making it a core pillar for the company's performance growth [3] - The new management strategy for IgA nephropathy aims to provide patients with hope for delaying disease progression and improving long-term outcomes [3] - The clinical data for the next-generation BTK inhibitor EVER001 is promising, indicating potential coverage for a broader range of kidney disease indications [2]

Group 1 - The core viewpoint of the report is that due to strong demand for Naisukan, the sales forecast for 2025 and 2026 has been raised, with the 2026 profit forecast adjusted from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Naisukan contributing 3.03 billion, a growth of 81% [2] - The company has set a sales target for Naisukan of 12-14 billion for 2025, which is over 200% growth year-on-year, and 24-26 billion for 2026, approximately 100% growth year-on-year [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas development, with EVER001 being a new generation covalent reversible BTK inhibitor showing positive results in clinical trials [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company's In vivo CAR-T platform has completed several studies in non-human primates, with plans to initiate clinical trials by the end of the year [3]

Group 1 - The core viewpoint is that due to strong demand for Nanfukang, the sales forecast for 2025 and 2026 has been raised, with a significant adjustment in the 2026 profit forecast from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Nanfukang contributing 3.03 billion, a growth of 81% [2] - Nanfukang's sales target for 2025 is set at 12-14 billion, indicating a year-on-year growth of over 200%, while the target for 2026 is 24-26 billion, reflecting a growth of approximately 100% [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas expansion, with positive results from ongoing clinical trials for kidney disease treatments [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company plans to initiate clinical trials for its In vivo CAR-T platform by the end of the year after completing several studies on non-human primates [3]

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].

Core Viewpoint - Cloudtop New Horizon Pharmaceutical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the expansion of production for its drug, Nefukang (Budenoside Enteric-Coated Capsules), which is the first and only approved treatment for IgA nephropathy in China, the US, and Europe, aiming to meet the growing clinical demand in China and Asia [2] Company Summary - Nefukang was approved in November 2023 through a priority review process, becoming the first approved drug for the cause of IgA nephropathy in China, filling a significant treatment gap [2] - The projected annual sales for Nefukang in 2024 are expected to reach 354 million yuan [2] - In November 2024, Nefukang will be included in the national medical insurance catalog, and by May 2025, it will receive full approval from NMPA, removing previous restrictions on proteinuria levels, thus expanding the potential patient population by three times [2] - Currently, Nefukang has covered over 80% of potential hospitals in China, benefiting more than 20,000 patients, indicating a strong demand for increased production capacity to meet patient needs [2] Industry Summary - China has the highest incidence rate of primary glomerular diseases globally, highlighting the urgent need for effective treatments like Nefukang [2] - Cloudtop New Horizon is also developing a next-generation covalent reversible BTK inhibitor, EVER001, which aims to address global clinical gaps in diseases such as primary membranous nephropathy (pMN), minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS) [2] - The company is advancing clinical research for a Gd-IgA1 diagnostic reagent, expected to be approved for market by 2026, which may replace kidney biopsy as an auxiliary diagnostic tool [2]

Core Viewpoint - Yunding Xinyao's core product, Nefukang (Budesonide enteric-coated capsules), has received approval from the National Medical Products Administration (NMPA) for production expansion, marking a significant step in addressing the clinical demand for IgA nephropathy treatment in China [1][2]. Group 1: Product and Market Demand - IgA nephropathy is a common primary glomerular disease with over 5 million patients in China, and more than 100,000 new cases diagnosed annually, indicating a high unmet clinical need [1]. - Nefukang has a unique mechanism that regulates intestinal mucosal immunity, reducing the production of Gd-IgA1, which is implicated in IgA nephropathy, effectively controlling proteinuria and protecting kidney function [1]. - Clinical data from the global Phase III NefIgArd study shows that Nefukang can reduce the risk of kidney function decline by 50%, with a 66% delay in kidney function deterioration for the Chinese population, potentially postponing the need for dialysis or kidney transplant by 12.8 years [1]. Group 2: Regulatory and Commercialization Progress - Nefukang has been included in both international and domestic clinical management guidelines, making it the only IgA nephropathy treatment recommended by both [2]. - Following its approval in November 2023, Nefukang filled a gap in the treatment of IgA nephropathy at the disease source and is expected to be included in the national medical insurance drug list by November 2024, expanding its eligible patient population threefold [2]. - The surge in market demand has led to supply constraints in Q2 2023, prompting the production expansion to address this issue and potentially serve as a turning point for Yunding Xinyao's performance [2]. Group 3: Future Potential and Strategic Developments - Nefukang's first full-year sales are projected to exceed 1 billion yuan, positioning it as one of the fastest-growing chronic disease drugs in China, with peak sales estimates reaching 5 billion yuan [3]. - Yunding Xinyao also has a next-generation covalent reversible BTK inhibitor, EVER001, which is expected to address broader kidney disease areas and fill several global clinical gaps [3]. - The ongoing clinical research for the Gd-IgA1 diagnostic reagent aims to replace kidney biopsy for auxiliary diagnosis, creating a "diagnosis-treatment" loop that enhances the precision and effectiveness of kidney disease treatment [3].

Group 1 - The company completed a placement and subscription agreement on July 30, 2025, successfully placing a total of 22,561,000 shares at a price of HKD 69.70 per share [1] - The company issued the subscribed shares on August 1, 2025, after all conditions of the subscription were met [1] Group 2 - The net proceeds from the subscription amount to approximately HKD 1,553.39 million [2] - The company plans to allocate the net proceeds as follows: 50% (approximately HKD 776.69 million) for global R&D of pipeline products, 40% (approximately HKD 621.36 million) for ongoing commercialization efforts, and 10% (approximately HKD 155.34 million) for working capital and general administrative purposes [2]