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]

Group 1: Market Overview - The Hong Kong pharmaceutical sector showed significant recovery on February 6, with innovative drugs experiencing a rebound, particularly the Hong Kong Stock Connect Innovative Drug ETF (520880), which rose by nearly 2% after opening in the red [1] - Notable stocks included Nocera Biopharma, which surged over 12%, projecting revenues of 2.37 billion yuan for 2025, a year-on-year increase of approximately 134%, and an expected net profit of around 630 million yuan, marking its first profit [1] Group 2: Company Performance - Rongchang Biopharma and CanSino Biologics also reported profitability, with both companies forecasting net profit growth exceeding 100% year-on-year [1] - Ark Health announced a profit forecast of 7 to 10 million yuan for 2025, indicating a turnaround from losses, and raised approximately 144.3 million HKD to accelerate the development of its AI-driven chronic disease management platform [3] - Among the 10 component stocks of the Hong Kong Stock Connect Medical ETF (159137) that disclosed earnings forecasts, 9 are expected to report profits, with several companies like Zhaoyan New Drug, MicroPort Medical, and WuXi AppTec anticipating net profit growth of over 100% [3]

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 ...

（云顶新耀公告） 2月6日，云顶新耀发布公告称，其新药维适平®（精氨酸艾曲莫德片）在中国获得新药上市申请批准，用于治疗对传 统治疗或生物制剂应答不充分的中度至重度活动性溃疡性结肠炎成人患者。 公司将积极筹备维适平®的商业化上市，努力将该疗法尽快带给国内患者，并推动纳入国家医保目录。此次获批是公 司2030年发展战略的重要组成部分，战略明确提出以"BD合作+自研"双轮驱动，实现商业化和研发的双重价值。公司 计划到2028年实现收入规模超过100亿元人民币，到2030年超过150亿元人民币，收入年复合增长率预计在2025至2030 年超过50%。 此次批准基于亚洲多中心III期注册临床ENLIGHTUC研究及全球III期注册研究ELEVATEUC的结果，ENLIGHTUC研究 纳入340名患者，在治疗中达到了统计学显著性和良好的安全性特征。 ...

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].

公司将积极筹备维适平 的商业化上市，努力将该疗法尽快带给国内患者，并推动纳入国家医保目录。 此次获批是公司2030年发展战略的重要组成部分，战略明确提出以"BD合作+自研"双轮驱动，实现商业 化和研发的双重价值。公司计划到2028年实现收入规模超过100亿元人民币，到2030年超过150亿元人民 币，收入年复合增长率预计在2025至2030年超过50%。 此次批准基于亚洲多中心III期注册临床ENLIGHTUC研究及全球III期注册研究ELEVATEUC的结果， ENLIGHTUC研究纳入340名患者，在治疗中达到了统计学显著性和良好的安全性特征。 2月6日，云顶新耀发布公告称，其新药维适平 （精氨酸艾曲莫德片）在中国获得新药上市申请批准， 用于治疗对传统治疗或生物制剂应答不充分的中度至重度活动性溃疡性结肠炎成人患者。 ...

Core Viewpoint - The approval of the new drug, Weishiping, by the National Medical Products Administration of China marks a significant milestone for the company, aimed at treating moderate to severe active ulcerative colitis in adults who have inadequate response to traditional therapies or biologics [1] Group 1: Drug Approval and Clinical Trials - The approval is based on the results of the ENLIGHTUC study, a multicenter Phase III clinical trial in Asia involving 340 patients, which demonstrated statistical significance and good safety profiles for Weishiping [1] - The global Phase III study, ELEVATEUC, also contributed to the approval process, indicating robust clinical evidence supporting the drug's efficacy [1] Group 2: Commercialization and Strategic Goals - The company plans to actively prepare for the commercialization of Weishiping, aiming to make the therapy available to domestic patients as soon as possible and to push for its inclusion in the national medical insurance catalog [1] - This approval is a key component of the company's 2030 development strategy, which emphasizes a dual approach of "BD cooperation + self-research" to achieve both commercialization and research value [1] - The company targets to exceed 10 billion RMB in revenue by 2028 and over 15 billion RMB by 2030, with an expected compound annual growth rate of over 50% from 2025 to 2030 [1]

消息面上，2月6日午间，云顶新耀公布，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，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。公司表示将积极筹备维适平的商业化上市、尽快 将此疗法带给国内患者，并积极推动纳入国家医保目录。 公告指出，此次新药上市申请获批也是公司2030年发展战略的重要一部份，此发展战略明确提出以"BD 合作+自研"双轮驱动，实现商业化创造确定性价值、研究与试验发展创造成长性价值。公司将持续巩 固核心治疗领域优势，推进创新药研发和商业化，打造可持续增长的全球化创新型生物制药企业。 云顶新耀(01952)午后曾涨超5%，截至发稿，涨3.4%，报40.18港元，成交额1.51亿港元。 ...

智通财经APP获悉，云顶新耀(01952)午后曾涨超5%，截至发稿，涨3.4%，报40.18港元，成交额1.51亿 港元。 公告指出，此次新药上市申请获批也是公司2030年发展战略的重要一部份，此发展战略明确提出以"BD 合作+自研"双轮驱动，实现商业化创造确定性价值、研究与试验发展创造成长性价值。公司将持续巩 固核心治疗领域优势，推进创新药研发和商业化，打造可持续增长的全球化创新型生物制药企业。 消息面上，2月6日午间，云顶新耀公布，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，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。公司表示将积极筹备维适平®的商业化上市、 尽快将此疗法带给国内患者，并积极推动纳入国家医保目录。 ...