耐赋康被强仿，引发资本市场担忧。2025年12月，云顶新耀股价累计跌幅两成多，至今，股价还未收复 失地。 耐赋康也是云顶新耀收入的主要来源。根据云顶新耀此前披露的信息，耐赋康在2025年前三季度销售额 已突破10亿元。 目前云顶新耀也在发力其他新产品。今年2月份，该公司也宣布，国家药监局已批准维适平（精氨酸艾 曲莫德片）的新药上市许可申请，用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度 至重度活动性溃疡性结肠炎成人患者。该药的上市，为中重度活动性溃疡性结肠炎成人患者提供新的治 疗选择。 当天，云顶新耀宣布耐赋康专利维权取得关键进展。广州知识产权法院已于2026年2月26日作出民事裁 定书，全面支持公司提出的诉前行为保全申请，并责令相关仿制药企业立即停止侵权行为并停止挂网， 该裁定自作出之日起立即执行。 云顶新耀的耐赋康是一款原研产品，于2019年6月从瑞典Calliditas公司引入，并于2023年11月获得中国 药监局批准上市，用于治疗具有进展风险的原发性IgA肾病成人患者，填补了中国从疾病源头治疗IgA 肾病的空白。 耐赋康在中国的专利权有效期直至2029年5月7日才到期，但2025年12月 ...

2026年2月6日，港股创新药企云顶新耀(01952)宣布，其自身免疫性疾病领域的核心产品维适平 (精氨酸 艾曲莫德片, VELSIPITY )获得中国国家药品监督管理局(NMPA)批准上市，用于治疗对传统治疗或生物 制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎(UC)成人患者。 国际权威指南一线推荐 成熟商业化平台将加速维适平 市场落地 作为新一代高选择性S1P受体调节剂，维适平 每日一次口服，可实现快速起效和强效深度黏膜愈合，并 具有良好的安全性特征，具备最佳药物(best-in-disease)潜质，为成人溃疡性结肠炎患者提供新的一线治 疗选择，其商业化前景获业内广泛看好。据预测，其销售峰值或达50亿元，将成为云顶新耀继肾病领域 耐赋康 后的又一核心单品，此举也预示着其商业化版图有望迎来新一轮高速增长。 云顶新耀首席执行官罗永庆对此表示，此次维适平 在中国的获批，填补了中重度溃疡性结肠炎治疗领 域的重要空白，并为以深度黏膜愈合为目标的创新口服治疗提供了新的选择。公司将加快推进维适平 的商业化进程，并积极推动纳入国家医保目录，持续提升创新疗法在中国的可及性和可负担性，让更多 患者受益。 维 ...

Core Viewpoint - CloudTop New Drug Company (1952.HK) has received approval for its core product, Arginine Ecurimod Tablets (brand name: Weishiping), for the treatment of moderate to severe active ulcerative colitis (UC) in adults who have inadequate response, loss of response, or intolerance to conventional therapies or biologics [1] Group 1: Product Approval and Market Potential - The product is a next-generation high-selectivity S1P receptor modulator, taken once daily, and is expected to provide a new first-line treatment option for adult UC patients [1] - The incidence of ulcerative colitis in China has been rising, with a projected increase in patient numbers from approximately 980,000 in 2025 to about 1.5 million by 2031 [1] - Sales peak for Arginine Ecurimod Tablets is predicted to reach 5 billion, positioning it as a core product for CloudTop following the success of its nephrology product, Renfu Kang [1] Group 2: Commercialization and Accessibility - The CEO of CloudTop, Luo Yongqing, stated that the company will accelerate the commercialization process of Weishiping and actively promote its inclusion in the national medical insurance catalog [1] - The focus is on enhancing the accessibility and affordability of innovative therapies in China [1]

云顶新耀(01952)发布公告，中国国家药品监督管理局(NMPA)已批准维适平 (精氨酸艾曲莫德片, VELSIPITY )的新药上市申请(新药上市申请)，在中国用于治疗对传统治疗或生物制剂应答不充分、失 应答或不耐受的中度至重度活动性溃疡性结肠炎(UC)成人患者。 作为新一代高选择性鞘氨醇-1-磷酸(S1P)受体调节剂，维适平 每日一次口服，可实现快速起效和强效深 度黏膜癒合，并具有良好的安全性特征，为成人溃疡性结肠炎患者提供新的一线治疗选择。维适平 此 次获批，是基于亚洲多中心III期注册临床ENLIGHT UC研究(ES101002)的结果和全球III期注册研究 ELEVATE UC(包括ELEVATE UC 52和ELEVATE UC 12研究)的结果。ENLIGHT UC研究是迄今完成的最 大规模亚洲中重度活动性溃疡性结肠炎患者的III期注册临床研究，总计纳入340名患者。在12周诱导期 及40周维持期治疗中，维适平 治疗组在所有主要和次要疗效终点上均达到统计学显著性与临床意义， 且安全性良好，安全性特征与既往研究一致。ELEVATE UC III期注册研究中的ELEVATE UC 52和 ELEV ...

Core Insights - CloudTop New Medicine (HKEX: 1952.HK) has entered into a licensing agreement with Micot to acquire the candidate drug MT1013 for Secondary Hyperparathyroidism (SHPT) with an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB [1][3] - The acquisition aims to enrich the company's renal disease product line and secure high-potential innovative assets, particularly as the existing core product, Renfukang, has limited long-term revenue stability due to a small patient population [1][2] Group 1: Product and Market Strategy - The introduction of MT1013 complements the existing product portfolio, targeting a significant patient population in chronic kidney disease (CKD) and enhancing commercial efficiency through the existing sales team [2][3] - MT1013 is designed to address the shortcomings of current SHPT treatments, which often lead to gastrointestinal side effects and bone quality deterioration, by targeting both calcium-sensing receptors (CaSR) and osteogenic growth peptide (OGP) pathways [2][4] - The global chronic kidney disease drug market is projected to grow from $15.92 billion in 2025 to $23.02 billion by 2032, with a compound annual growth rate (CAGR) of 5.4% from 2025 to 2032, indicating a strong market opportunity for innovative treatments like MT1013 [3][4] Group 2: Competitive Landscape - The market is shifting from single-target drugs to differentiated innovative assets, with MT1013's dual-target design meeting the industry's demand for unique mechanisms of action [4][5] - The evaluation criteria for drug efficacy are evolving from focusing solely on single metrics to a comprehensive assessment of overall health benefits for patients, which is becoming a key competitive factor in the innovative drug market [5][6] - The trend towards multi-target therapies is gaining traction in CKD research, as the complexity of disease mechanisms necessitates a more holistic approach to treatment [5][6] Group 3: Implications for Stakeholders - The transaction reflects a trend towards more specialized roles within the pharmaceutical industry, where developers focus on technical advancements while commercial entities concentrate on market realization [6][7] - For innovative entrepreneurs, maintaining a clinical demand orientation and establishing differentiated barriers is crucial, as is anticipating commercial competition and designing robust clinical trial data [6][7] - For investment institutions, prioritizing late-stage assets with head-to-head data and focusing on high-demand areas like SHPT can mitigate risks associated with research failures [6][7]

此前，云顶新耀已凭借全球首个IgA肾病对因治疗药物耐赋康在肾病治疗领域崭露头角。该公司财务数据显示，2025年前 三季度，耐赋康的销售额突破10亿元。云顶新耀方面表示："耐赋康的成功，不仅验证了云顶新耀在肾科领域的渠道覆盖与学 术推广能力，更依托于云顶新耀搭建起的以科学和商业洞察为基础的'准入、医学、市场、销售'（A2MS）一体化的商业化运 营平台。MT1013的加入，将与云顶新耀现有的肾科产品组合形成高度协同，推动公司肾科布局从覆盖IgA肾病拓展至更广泛的 慢性肾脏病，进一步完善肾科产品矩阵，夯实其在肾科领域的布局优势。" 对于此次合作，云顶新耀董事会主席吴以芳表示："在全球慢性肾脏病患者持续增加的背景下，继发性甲状旁腺功能亢进 仍存在显著临床未满足需求。MT1013作为具备全球首创双重作用机制的临床后期创新资产，有望为SHPT患者提供全新的治疗 选择。作为潜在同类最佳药物，MT1013将与公司现有的肾科产品组合形成高度协同，进一步夯实公司在肾科领域的布局。云 顶新耀在持续深耕自身免疫相关肾脏疾病的基础上，正加速拓展至肾小球肾炎以及慢性肾脏病及其并发症等更广泛的治疗领 域。此次合作是公司完善创新管线、拓展肾 ...

Core Insights - CloudTop Innovations (01952.HK) received the "Annual Innovation Award" at the "Technology Empowerment · Capital Breakthrough" conference, highlighting a shift in the Chinese innovative pharmaceutical industry towards valuing sustainable value creation over merely chasing "star pipelines" [1] - The Chinese biopharmaceutical industry is transitioning from a phase of rapid growth focused on scale to a high-quality development phase emphasizing technological depth and commercial efficiency [1] - Capital is increasingly focused on companies that can integrate cutting-edge research with mature commercialization systems, establishing new benchmarks in the market [1] Company Strategy - CloudTop's "2030 Development Strategy" is centered on a dual-engine model of "Business Development (BD) cooperation + independent R&D," supported by its unique A2MS (Access, Medical, Market, Sales) commercialization platform [3][7] - The A2MS platform serves as the "value conversion hub" of the company's strategy, addressing core challenges in the commercialization of innovative drugs by streamlining the entire process from insurance access to patient management [3] Product Commercialization - The commercialization of the core product, NAI-Fu-Kang®, is a benchmark in the industry, achieving over 1 billion RMB in sales within its first commercial year, marking a significant milestone for chronic disease medications in China [4] - The company has also seen steady growth in sales for its antibiotic product, Yi-Jia®, with a 6% year-on-year increase in revenue for the first half of 2025, and a 37% increase in sales through targeted core hospitals [5] Future Outlook - CloudTop aims to expand its product portfolio to over 20 commercialized products by 2030, with projected revenues exceeding 15 billion RMB [8] - The company is also advancing its global strategy, focusing on a dual-engine growth model of "overseas licensing + commercialization" to accelerate internationalization [8] Market Recognition - The company's strategic direction has garnered confidence from both internal management and capital markets, with key executives increasing their shareholdings, signaling strong belief in the company's long-term value [9] - Investment firms have positively evaluated the company's growth logic, recognizing its integrated mRNA platform as a potential driver for transitioning from a commercialization entity to a technology-driven innovative enterprise [9] Industry Context - CloudTop's trajectory reflects a broader transformation in the Chinese innovative pharmaceutical landscape, emphasizing the importance of systematic platform capabilities that can continuously foster innovation and bring scientific breakthroughs to market [11] - The competitive landscape is shifting from broad strategic layouts to a focus on the depth of systemic capabilities, with companies like CloudTop positioned to lead and shape the next generation of treatment standards [11]

Market Performance - The Hang Seng Index closed at 25,854, up 0.86% for the day and up 28.89% year-to-date [1] - The Hang Seng Tech Index rose 1.74% to 5,578, with a year-to-date increase of 24.85% [1] - The Dow Jones Index decreased by 0.20% to 48,367, with a year-to-date increase of 13.69% [1] - The S&P 500 Index fell 0.14% to 6,896, with a year-to-date increase of 17.25% [1] - The Nasdaq Index dropped 0.24% to 23,419, with a year-to-date increase of 21.27% [1] Currency and Commodity Performance - The Renminbi Index is at 97.640, down 0.59% over the last month but up 1.79% over six months [2] - Brent crude oil is priced at $62.040 per barrel, down 0.55% over the last month and down 4.14% over six months [2] - Gold is priced at $4,373.23 per ounce, up 3.31% over the last month and up 32.37% over six months [2] - Silver has seen a significant increase of 28.60% over the last month, now priced at $74.616 per ounce, and up 106.52% over six months [2] Economic Indicators - The Federal Reserve's meeting minutes indicate that most officials expect further rate cuts if inflation decreases as anticipated [10] - As of the end of September, China's banking sector had $18,114 billion in foreign financial assets and $14,399 billion in foreign liabilities, resulting in a net asset of $3,716 billion [11] - The total social logistics volume in China for the first eleven months increased by 5.0% year-on-year, with a monthly increase of 4.5% in November [12] Company-Specific News - Pop Mart's second-hand prices for blind boxes have significantly dropped, with average prices falling from 1,478 RMB to 632 RMB [13] - Kubo Medical has invested $15 million to acquire a stake in Valgen from Qiming Medical, aiming to enhance its capabilities in cardiopulmonary disease diagnostics and treatment [14] - CloudTop New Drug has confirmed that its original drug "Nai Fu Kang" remains under effective patent protection in China [15][16] - MicroPort Medical has terminated its merger with MicroPort Brain Science due to control issues following the appointment of an independent non-executive director [18] IPO and Market Activity - Six newly listed stocks closed above their offering prices, with Ying Silicon Smart and May Day Vision showing strong performances, rising nearly 25% and 30% respectively [5] - The Hong Kong stock market saw a total turnover of approximately 199.8 billion HKD, with the Hang Seng Index gaining 219 points [5]

Core Viewpoint - Hainan Huirui Pharmaceutical has received approval for the first domestic generic version of Budesonide enteric-coated capsules, breaking the monopoly of Cloudy New Yao in the IgAN treatment market and reshaping the competitive landscape in this field [1][13]. Group 1: Product Approval and Market Impact - Budesonide enteric-coated capsules are an innovative oral targeted delayed-release formulation for treating adult patients with primary IgA nephropathy at risk of progression, filling a gap in domestic treatment options [5]. - The original developer of Budesonide is Calliditas, which granted Cloudy New Yao commercialization rights in Greater China and Singapore in 2019. The product was approved for domestic sale on November 21, 2023, under the brand name "Naifukang" [6]. - Budesonide enteric-coated capsules are set to be included in the medical insurance reimbursement list starting January 1, 2025 [6]. Group 2: Sales Performance and Market Position - In the first seven months post-launch, Naifukang contributed 353 million yuan in revenue to Cloudy New Yao, marking a year-on-year increase of 1581% and accounting for half of the company's total sales [9]. - Sales of Budesonide-related formulations in hospitals nationwide are expected to exceed 4.5 billion yuan in the first half of 2025, with the enteric-coated capsules ranking among the top five products in the nephrology field [9][12]. Group 3: Competitive Landscape and Future Prospects - Currently, only Everest Medicines has been approved to import Budesonide, while Hainan Huirui has secured the first domestic generic approval, challenging Cloudy New Yao's market dominance [13]. - Other companies, including Qilu Pharmaceutical and Shijiazhuang Yaozhu Pharmaceutical, have also submitted applications for generic versions, which are under review [13]. - Budesonide enteric-coated capsules have been recommended in multiple authoritative treatment guidelines due to their innovative mechanism and clinical advantages [16]. - The patent for Budesonide is set to expire in May 2029, allowing for the potential entry of more generics into the market unless patent extensions are granted [16].

Core Insights - By 2025, China's innovative pharmaceutical industry is projected to have a market size ranking second globally, with approximately 30% of innovative drugs in development worldwide [1] - The total amount of foreign licensing for domestic innovative drugs has surpassed $100 billion, doubling compared to 2024 [1] - The shift from a Western-dominated landscape in biopharmaceutical innovation is evident, as Chinese biotech companies have outperformed their U.S. counterparts in stock price growth over the past year [1] Industry Development - The past decade has seen significant reforms in drug regulation, fostering an ecosystem for innovation and facilitating capital flow, supported by China's large population and manufacturing capabilities [1] - Despite impressive growth, challenges remain, including the total market capitalization of Chinese biotech companies being less than 15% of their U.S. counterparts and lower upfront licensing fees [1] Commercialization Strategies - Leading innovative pharmaceutical companies are advancing towards the global value chain, with firms like Kangfang Biotech transitioning from licensing revenue to self-driven commercialization [2] - Companies are focusing on both global product development and establishing scalable commercialization platforms, which is becoming a core strategy for Chinese biotech firms [2] Global Competition - Chinese pharmaceutical companies are transitioning from "fast-followers" to "first movers," evidenced by significant business development deals with major international firms [3] - The emergence of mRNA technology is notable, with several Chinese companies making strides in this area, including clinical trials for mRNA-based vaccines [3][4] Market Dynamics - The commercialization of innovative drugs in China is accelerating, with 56 innovative drugs approved by the National Medical Products Administration in the first eight months of 2025 [6] - Successful commercialization is critical, as only about 5% of drugs entering clinical trials make it to market, and only 20% of those achieve profitability [6] Future Outlook - Companies like CloudTop are aiming to enhance their commercialization capabilities and expand their product pipelines significantly by 2030, with projected revenues exceeding 15 billion yuan [4][11] - The industry is expected to see a consolidation of platform companies with revenues between 5 billion to 10 billion yuan, indicating a shift in the commercialization landscape [9][10]