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 ...

云顶新耀首席执行官罗永庆表示，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。 本报讯(记者金婉霞)2月6日，港股创新药企云顶新耀有限公司(以下简称"云顶新耀")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)获得中国国家药品监督管理局批准上市，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。 记者从云顶新耀进一步获悉，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，为成人溃疡 性结肠炎患者提供新的一线治疗选择。维适平在亚太地区的临床试验牵头研究者、空军军医大学西京消 化病医院吴开春教授表示，维适平通过调控淋巴细胞迁移，从源头控制肠道炎症，并促进黏膜愈 合。"在多个临床研究中，维适平展现出显著疗效，尤其在快速起效、实现无激素缓解及深度黏膜愈合 方面具有明显临床优势。"吴开春表示，其亚洲多中心三期ENLIGHT UC研究显示，维适平维持治 ...

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]

智通财经APP获悉，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。 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。 维适平®获批填补临床空白 推动UC慢病 ...

Core Viewpoint - Yunding Xinyao's core product VELSIPITY has received approval from the NMPA for treating moderate to severe active ulcerative colitis (UC) in adults, filling a significant gap in treatment options and is expected to generate peak sales of 5 billion RMB [1][6]. Group 1: Product Approval and Market Potential - VELSIPITY is a new generation S1P receptor modulator that offers rapid onset and effective mucosal healing, providing a new first-line treatment option for UC patients [1][3]. - The approval of VELSIPITY is anticipated to drive significant growth for Yunding Xinyao, marking a major breakthrough in the autoimmune disease sector [6][7]. - The drug's peak sales potential is projected to reach 5 billion RMB, contributing to the company's revenue growth alongside existing products [6][7]. Group 2: Clinical Efficacy and Guidelines - Clinical studies have shown VELSIPITY's efficacy, with a clinical remission rate of 48.1% and a mucosal healing rate of 51.9% after 40 weeks of treatment [3][4]. - VELSIPITY has been included in major international clinical guidelines as a first-line treatment for UC, reflecting its recognized clinical value [4][5]. Group 3: Commercialization Strategy - Yunding Xinyao has established a comprehensive A2MS operational system to efficiently promote VELSIPITY's market entry and clinical application [5][6]. - The company aims to accelerate the commercialization process and integrate VELSIPITY into the national medical insurance directory to enhance accessibility for patients [1][6]. Group 4: Future Growth and Strategic Goals - Yunding Xinyao's 2030 strategic goal includes achieving over 15 billion RMB in revenue and expanding its product portfolio to over 20 commercialized products [6][7]. - The company expects a compound annual growth rate of over 50% from 2025 to 2030, with a focus on both BD collaborations and independent research and development [7].

Core Viewpoint - APL-1401, an innovative oral drug developed by the company for the treatment of moderate to severe active ulcerative colitis, has had its phase Ib clinical trial results selected for presentation at the 19th European Colorectal Congress (ECC) [1] Group 1: Clinical Trial Results - The phase Ib clinical trial results of APL-1401 were presented in poster format at the ECC [1] - APL-1401 is designed to treat autoimmune diseases through a novel mechanism of action [1] Group 2: Drug Mechanism - APL-1401 is a potent and selective dopamine β-hydroxylase (DBH) inhibitor [1] - By inhibiting DBH, APL-1401 blocks the only catalytic enzyme for the synthesis of norepinephrine (NE) from dopamine (DA), leading to increased DA and decreased NE, which helps restore intestinal immune homeostasis [1]

Core Insights - The innovative drug Etrasimod (VELSIPITY) developed by the company for treating moderate to severe active ulcerative colitis (UC) has shown promising results in the ENLIGHT UC Phase III clinical study, published in The Lancet Gastroenterology & Hepatology [1][2] - The study demonstrated a mucosal healing rate of 51.9% and a complete normalization rate of 45.5% after 52 weeks of treatment, significantly higher than the current 24% rate among patients achieving mucosal healing [1][3] - Etrasimod is anticipated to reach peak sales of 5 billion yuan, positioning it as a key product alongside the company's existing offerings in the autoimmune disease sector [1][5] Study Details - The ENLIGHT UC study was a multicenter, randomized, double-blind, placebo-controlled trial involving 340 patients who had previously failed or were intolerant to standard treatments for UC [2][3] - Results indicated statistical significance and clinical relevance across all primary and secondary efficacy endpoints during both the 12-week induction and 40-week maintenance phases [2] Clinical and Market Implications - The increasing prevalence of UC in Asia, with an estimated 800,000 patients in China by 2024 projected to rise to nearly 1.5 million by 2031, highlights the urgent clinical need for effective treatments [3][4] - Etrasimod's mechanism as a high-selectivity oral S1P receptor modulator aligns with the core treatment needs for UC, offering advantages such as rapid onset of action and deep mucosal healing [4][5] - The drug has been recognized in clinical guidelines, being recommended as a first-line treatment for UC by the American Gastroenterological Association and the American College of Gastroenterology [4][5] Commercialization Progress - Etrasimod has received approvals in regions such as Macau, Singapore, and Hong Kong, with new drug applications (NDA) accepted in Taiwan and South Korea [5] - The company has initiated local production in Zhejiang, aiming for an annual capacity of 50 million tablets to ensure supply [5] - The NDA for Etrasimod in mainland China is expected to be approved by mid-2026, which will benefit domestic patients [5]

Group 1 - Neusoft Group has received a notification from a well-known domestic automobile manufacturer, designating it as the supplier for intelligent cockpit domain controllers, with a total expected supply amount of approximately 5.6 billion RMB over a lifecycle of about 4 years starting from Q4 2026 [1] - Fulin Precision has signed a prepayment agreement with CATL for a total of 1.5 billion RMB to secure lithium iron phosphate supply, enhancing their strategic cooperation in the material field [2] - Shiyun Circuit plans to launch its new generation PCB product "Chip Creation Smart Carrier" by mid-2026, targeting emerging sectors such as AI, new energy vehicles, and humanoid robots, with potential future supply to Tesla [3] Group 2 - Fengshan Group has signed a technical development contract with Tsinghua University for the development of sodium-ion battery electrolytes and solid-state lithium-ion battery electrolytes, with a total contract amount of 2 million RMB [4] - Jinghua New Materials reported that senior management collectively reduced their holdings by 141,000 shares on September 16, amid significant stock price fluctuations [5] - Huaqin Technology's five major shareholders have decided to terminate their share reduction plan early, having collectively reduced 38.96 million shares [6] Group 3 - Heng Rui Medicine's subsidiary has received approval for clinical trials of SHR-1139 injection, a self-developed therapeutic biological product for ulcerative colitis, with no similar drugs approved in the market [7] - ST Chuangxing announced that its chairman is under investigation, but the matter is unrelated to the company, and daily operations will continue under the management team [8]

Core Insights - The innovative drug Etrasimod (VELSIPITY(R)) from the company has been strongly recommended in the 2025 ACG Clinical Guidelines for the treatment of moderate to severe active Ulcerative Colitis (UC) patients, highlighting its clinical value and potential to meet unmet treatment needs [1][2][3] Group 1: Clinical Guidelines and Recommendations - Etrasimod is recommended for both induction and maintenance therapy in moderate to severe active UC patients, based on moderate quality evidence [1] - The guidelines suggest continuing Etrasimod for patients who have achieved induction remission with S1P receptor modulators, indicating its role in maintaining remission [1] - The guidelines emphasize the importance of achieving endoscopic mucosal healing as a core treatment goal for moderate to severe UC, which is linked to improved long-term management and quality of life for patients [3] Group 2: Clinical Trial Results - The ELEVATE UC III phase registration studies (ELEVATE UC 52 and ELEVATE UC 12) achieved all primary and key secondary endpoints, showing significant improvement in clinical remission rates at 12 weeks and 52 weeks [2] - Notably, 100% of clinical remissions were steroid-free, indicating a favorable safety profile consistent with previous studies [2] - The guidelines also highlight Etrasimod's effectiveness in patients with Ulcerative Proctitis, showing a significant increase in clinical remission rates compared to existing treatments [2] Group 3: Market and Commercialization - The number of UC patients in Asia is rising, with an estimated 800,000 patients in China by 2024, projected to reach 1 million by 2030, indicating a growing need for effective treatment options [4] - The company is accelerating the commercialization process of Etrasimod, aiming to provide long-term effective disease management and improve patient quality of life [4] - Etrasimod's new drug application has been accepted by the Chinese National Medical Products Administration, with expected approval by the end of 2024 or early 2025, and it has already been approved in several regions including Singapore and Hong Kong [4]

Core Insights - Yunding Xinyao's core product, Etrasimod (VELSIPITY), has been included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis, receiving strong recommendations for induction and maintenance therapy in moderate to severe active UC patients [1][2] - The inclusion in both the ACG and AGA guidelines highlights Etrasimod's clinical value and its potential to fill treatment gaps in ulcerative colitis [1][2] Clinical Efficacy and Safety - Etrasimod is a next-generation S1P receptor modulator that retains activated lymphocytes in lymph nodes, reducing their infiltration in the gut and local inflammation, demonstrating unique advantages in efficacy and safety [2] - The ELEVATE UC III phase studies showed significant improvements in clinical remission rates at 12 weeks (43.2% for Etrasimod vs. 13.6% for control, p<0.001) and sustained endoscopic mucosal healing [2][3] - Long-term safety data from global studies indicate a low adverse event rate of 1.63 per patient-year, confirming Etrasimod's good tolerability over four years [4] Market Potential and Commercialization - The prevalence of ulcerative colitis is increasing, with an estimated 800,000 patients in China by 2024, projected to rise to 1 million by 2030, providing a substantial market opportunity for Etrasimod [5][6] - Etrasimod is expected to receive regulatory approval in Macau, Singapore, and Hong Kong in 2024, with applications in mainland China and other regions under review, indicating an accelerated commercialization process [6] - The company plans to invest 70 million yuan in a production facility in Zhejiang, aiming for an annual capacity of 50 million tablets to meet market demand [6] - Industry forecasts suggest Etrasimod's peak sales could reach 5 billion yuan, significantly contributing to the company's revenue growth [6] Strategic Goals - Yunding Xinyao is advancing its portfolio in nephrology, infectious diseases, and mRNA technology, aiming for 10 billion yuan in sales by 2030 [7] - The company is positioning itself as a leading biopharmaceutical enterprise in Asia, driven by the commercialization of Etrasimod and its innovative drug pipeline [7]