在全球化能力建设方面，公司启动全球化战略，推进全球化的注册及临床开发能力建设。到2030年，公 司计划透过「海外授权+商业化」的双引擎驱动增长，加快国际化发展步伐。 格隆汇2月6日丨云顶新耀(01952.HK)宣布，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(「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。 在疾病领域，公司聚焦肾科、自身免疫、急重症、心血管及眼科等核心方向，通过引进创新资产与自主 研发并行推进，到2030年形成高价值产品组合，并拓展其他蓝海领域的大单品。 在商业化平台建设上，公司已布局三款商业化产品，并着力建立全渠道商业化体系及药品全生命周期商 业化能力。公司计划到2028年实现收入规模超过100亿元人民币，而到2030年收入规模超过150亿元人民 币(其中现有管线销售收入约90亿元人民币而新引进管线销售收入约60亿元人民币)；收入的年复合增长 率预计在2025至2030年超过50%，2030年後保持超过15%。同时，商业化产品数量将提升至20 ...

每经AI快讯，2月6日，云顶新耀公告，中国国家药品监督管理局已批准维适平新药上市申请，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成人患 者。 ...

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 ...

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 ...

在全球化能力建设方面，公司启动全球化战略，推进全球化的注册及临床开发能力建设。到2030年，本 公司计划透过"海外授权+商业化"的双引擎驱动增长，加快国际化发展步伐。 2030年发展战略标志着本公司迈向全球生物制药前沿的重要里程碑。未来五年，公司将聚焦"BD合作 +自研"双轮驱动，依托科学与市场洞察，推动战略领域形成 N+X产品组合，把握蓝海大单品机遇。本 公司计划通过已经建立的商业拓展能力，每年引进3至5个中后期重磅产品，依托自身精干高效的商业化 团队实现每个产品医保后三年销售达峰。未来五年，公司计划引进20个以上的高值资产，为 2030年贡 献收入60亿元人民币，并在2035年实现大约300亿元人民币的收入贡献。 通过此战略布局，本公司致力于在核心治疗领域和创新药研发上持续领先，打造可持续增长的全球化创 新型生物制药企业，致力于成为全球领先的综合性生物制药公司。 此次新药上市申请获批亦是本公司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(研发)创造成长性价值。本公司将持续巩 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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該 等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 自願公告 最新業務情況 有關維適平®用於治療成人患者中重度潰瘍性結腸炎的 新藥上市申請在中國獲批及其他企業最新動態 本公告由雲頂新耀有限公司（「本公司」）自願作出，以向本公司股東及潛在投資者 提供有關最新業務資料。 本 公 司 董 事 會（「董 事 會」）欣 然 宣 佈 ， 中 國 國 家 藥 品 監 督 管 理 局 (NMPA) 已 批 准 維 適平®（ 精氨酸艾曲莫德片, VELSIPITY ® ）的新藥上市申請（「新藥上市申請」），在 中國用於治療對傳統治療或生物製劑應答不充分、失應答或不耐受的中度至重度 活動性潰瘍性結腸炎（「UC」）成人患者。 作為新一代高選擇性鞘氨醇-1 -磷酸(S1P)受體調節劑，維適平®每日一次口服，可 實現快速起效和強效深度黏膜癒 ...

Major Events - Genting New Year (01952) subsidiary signed an agreement with Macao to commercialize MT1013 in Greater China and other Asian markets [1] - Junshi Biosciences (02696) entered into a licensing agreement with Eisai for Hansizhuang® to treat tumor indications [1] - Meituan-W (03690) plans to acquire all issued shares of Dingdong Fresh Holding Limited [1] - China Power (02380) subsidiary Xinyuan Zhichu signed a procurement contract for BESS with Tori [1] - Aimee Vaccine (06660) successfully passed the registration site inspection for its globally self-researched serum-free rabies vaccine [1] Operating Performance - NIO-SW (09866) issued a profit warning, expecting adjusted operating profit of 700 million to 1.2 billion yuan in Q4 2025, turning from loss to profit year-on-year [1] - Saint Bella (02508) issued a profit warning, expecting adjusted net profit of no less than 120 million yuan for 2025, a year-on-year increase of no less than 183% [1] - Geek+ (02590) achieved orders of 4.137 billion yuan in 2025, a year-on-year growth of approximately 31.7% [1] - China Overseas Development (00688) achieved contract property sales of approximately 14.478 billion yuan in January, a year-on-year increase of 20.4% [1] - Swire Properties (01972) reported a rental rate of 96% for Swire Plaza in Q4, with rents down by 13% [1] - Greentown China (03900) reported total contract sales of approximately 9.7 billion yuan in January, a year-on-year decrease of 14.16% [1]

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]

Group 1 - The core viewpoint of the news is that CloudTop New Medicine has signed an exclusive commercialization license agreement with Macao to obtain global rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan) [1][2] - CloudTop will pay Macao a signing fee of 200 million RMB and potential regulatory and commercial milestone payments of up to 1.04 billion RMB [1] - The collaboration is a strategic move for CloudTop to enhance its innovative pipeline and expand its treatment capabilities in nephrology, creating a strong synergistic effect with its existing nephrology pipeline [1][2] Group 2 - The chairman of CloudTop, Wu Yifang, emphasized the significant unmet clinical needs in secondary hyperparathyroidism (SHPT) against the backdrop of a rising number of chronic kidney disease patients globally [2] - MT1013 is expected to provide a new treatment option for SHPT patients, positioning it as a potential best-in-class drug that will synergize with the company's existing nephrology product portfolio [2] - The partnership marks a shift in CloudTop's nephrology strategy from focusing on a single disease to a more systematic and platform-based approach, aiming to expand into broader treatment areas such as glomerulonephritis and chronic kidney disease and its complications [2]

| 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01952 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 雲頂新耀有限公司 呈交日期: 2026年2月5日 I. 法定/註冊股本變動 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 ...