Core Viewpoint - Cloud-based innovative pharmaceutical company, Yunding Xinyao (1952.HK), has made significant progress in the market access of its key product for autoimmune diseases, with the Taiwan FDA officially accepting the New Drug Application (NDA) for Aiqumote (维长宁) for treating moderate to severe active ulcerative colitis (UC) patients [1] Group 1: Product Development and Market Access - The NDA for Aiqumote was formally accepted by the National Medical Products Administration (NMPA) in mainland China in December 2024, with expectations for approval by the end of this year or early next year [1] - The acceptance of the NDA in Taiwan further strengthens the commercial layout of Aiqumote in Asia, laying a solid foundation for future market entries in more Asian countries [1] - Industry forecasts suggest that Aiqumote's peak sales could reach 5 billion yuan, positioning it as the next major product following Nairfukang (布地奈德肠溶胶囊) [1] Group 2: Clinical Need and Treatment Landscape - Ulcerative colitis is a chronic, recurrent inflammatory bowel disease with a complex pathogenesis and significant treatment challenges, leading to increased disability and colorectal cancer rates among patients [2] - In China, the number of ulcerative colitis patients is projected to grow from approximately 800,000 in 2024 to 1 million by 2030, highlighting a substantial unmet clinical need [2] - Current treatment options are limited, with existing medications, including JAK inhibitors, carrying serious risks such as severe infections and malignancies, prompting the FDA to issue black box warnings [2] Group 3: Efficacy and Safety of Aiqumote - Aiqumote is an oral first-line treatment for ulcerative colitis, demonstrating strong efficacy in achieving mucosal healing and offering good safety profiles [2] - Recent data from the 13th Asian Organization for Crohn's and Colitis (AOCC 2025) annual meeting confirmed Aiqumote's long-term safety and tolerability, reinforcing its advantages as an innovative therapy for moderate to severe UC [2][3] - Aiqumote has been included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for ulcerative colitis, further validating its clinical value [3] Group 4: Clinical Research and Evidence - The NDA application for Aiqumote is based on results from the ELEVATE UC Phase III registration studies, which demonstrated superior and sustained clinical remission and mucosal healing at both 12 and 52 weeks [3][4] - The ENLIGHT study, the largest Phase III clinical trial for moderate ulcerative colitis in Asia, reported a 52% mucosal healing rate and a 46% complete normalization rate after 52 weeks, providing strong evidence for Aiqumote's application in Asian patients [4] Group 5: Local Production and Market Expansion - Yunding Xinyao is advancing the local production of Aiqumote, with a production facility in Jiaxing set to support supply after its launch in mainland China [5] - Aiqumote has already been approved for sale in Singapore, Macau, and Hong Kong, with a listing application in South Korea accepted in June this year [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]

Core Insights - The article highlights the strong recommendation of Etrasimod (VELSIPITY®) for the treatment of moderate to severe active ulcerative colitis (UC) in the newly released 2025 ACG Clinical Guidelines, indicating its clinical value and potential to fill a treatment gap in UC [1][2][3] Group 1: Clinical Value and Research Support - Etrasimod is recognized as a new generation S1P receptor modulator, with a mechanism that retains activated lymphocytes in lymph nodes, reducing their infiltration in the gut and local inflammation, showcasing unique advantages in efficacy and safety [2][3] - The ELEVATE UC III phase registration studies (ELEVATE UC 52 and ELEVATE UC 12) demonstrated significant improvements in clinical remission rates at both 12 weeks and 52 weeks, with 100% of clinical remissions being steroid-free [2][4] - The clinical remission rate for the Etrasimod group at 12 weeks was 43.2%, significantly higher than the control group's 13.6% (p<0.001) [2][3] Group 2: Market Potential and Commercialization - The Asian market for ulcerative colitis is expanding, with an estimated 800,000 patients in China by 2024, projected to reach 1 million by 2030, providing a substantial commercial opportunity for Etrasimod [6] - Etrasimod's commercialization in Asia is accelerating, with approvals expected in Macau, Singapore, and Hong Kong in 2024, and applications submitted in South Korea and Taiwan [6] - The company plans to start production at its Zhejiang Jiaxing factory in March 2025, with an investment of 70 million yuan, aiming for an annual capacity of 50 million tablets to meet market demand [6] Group 3: Strategic Positioning and Future Goals - Etrasimod is viewed as the next blockbuster product for the company, with sales potential estimated to reach 5 billion yuan [7] - The company aims to achieve 10 billion yuan in sales by 2030, supported by a diverse pipeline in nephrology, infectious diseases, and mRNA technology [7] - The management team has extensive global pharmaceutical experience, positioning the company towards becoming a leading comprehensive biopharmaceutical enterprise in Asia [7]

Group 1 - The core point of the news is that Cloudtop New Horizon (01952.HK) has received acceptance from Taiwan's drug regulatory authority for the new drug application of Aicmod (维长宁) for treating moderate to severe active ulcerative colitis (UC) patients, marking a significant step in its market entry in Asia [1] - Aicmod has already been approved in Macau, Singapore, and Hong Kong, with South Korea also accepting its new drug application. The National Medical Products Administration of China has accepted the application for Aicmod, with approval expected by the end of this year or early next year [1] - The number of ulcerative colitis patients in China is projected to reach 1 million by 2030, with a current estimate of 800,000 in 2024, indicating a growing unmet medical need in the region [1] Group 2 - Aicmod is recognized as a first-line oral treatment for ulcerative colitis, demonstrating strong efficacy in achieving mucosal healing and good safety profiles based on the results of the ELEVATE UC Phase III studies [2] - The ENLIGHT study, the largest Phase III clinical trial for moderate ulcerative colitis in Asia, showed significant clinical and statistical differences in treatment outcomes, supporting Aicmod's application in this patient population [2] - Aicmod has been included in the list of urgently needed imported drugs in the Guangdong-Hong Kong-Macao Greater Bay Area, and local production is set to begin in March 2025 to support commercialization in Greater China and other Asian markets [3] Group 3 - The market potential for Aicmod is widely regarded as promising, with industry forecasts predicting peak sales could reach 5 billion yuan, making it a key driver of the company's revenue growth [3]

Core Viewpoint - CloudTop New Drug (01952) has made significant progress in the commercialization of its innovative drug, Eiqumod (维长宁), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Eiqumod has received regulatory approvals in Macau, Singapore, Hong Kong, and its NDA has been accepted in South Korea, marking important advancements in its market access across Asia [1] - The drug is expected to receive approval from the National Medical Products Administration (NMPA) in China by the end of 2024 or early 2025 [1] - Eiqumod is recognized as a first-line oral treatment that effectively promotes mucosal healing in UC patients, which is a key treatment goal according to clinical guidelines [1][2] Group 2: Clinical Research and Efficacy - The NDA application for Eiqumod is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC52 and ELEVATE UC12) and the ENLIGHT study (ES101002), which demonstrated significant clinical efficacy and safety [2][3] - The ELEVATE UC studies showed that Eiqumod achieved both clinical remission and deep mucosal healing at 12 and 52 weeks, with 100% of clinical remission being steroid-free [2] - The ENLIGHT study is the largest Phase III clinical trial for moderate UC in Asia, involving 340 patients, and provided strong evidence for the drug's application in this patient population [3] Group 3: Market Potential and Strategic Initiatives - The CEO of CloudTop highlighted the growing number of UC patients in Asia, with an estimated 800,000 patients in China in 2024, projected to reach 1 million by 2030, indicating a significant unmet medical need [2] - Eiqumod has been included in the urgent import drug list for the Greater Bay Area in 2024, allowing for early access to patients in that region [3] - The company has initiated local production of Eiqumod in its Jiaxing facility to support supply and commercialization in Greater China and other Asian markets [3][4] Group 4: Company Overview - CloudTop New Drug focuses on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, aiming to meet unmet medical needs in the Asian market [5] - The management team has extensive experience in high-quality research and development, regulatory affairs, and commercialization operations within leading pharmaceutical companies [5]

智通财经APP获悉，云顶新耀(01952)是一家专注于创新药研发、临床开发、制造和商业化的生物制药公 司，近日宣布中国台湾地区药政主管部门(TFDA)已正式受理维长宁®(艾曲莫德，中国台湾地区商品 名：維長寧®)用于治疗中重度活动性溃疡性结肠炎(UC)患者的新药上市许可申请(NDA)。此次受理标志 着艾曲莫德继中国澳门、新加坡和中国香港获批和韩国NDA获正式受理之后，其在亚洲市场的准入取 得重要进展。中国国家药品监督管理局也于2024年12月正式受理艾曲莫德(维适平®)的新药上市申请， 预计今年年底或明年年初获批。 艾曲莫德是一款针对溃疡性结肠炎，每日一次的口服一线治疗药物，能够强效实现肠道黏膜愈合，且使 用便捷，并具有良好的安全性特征。黏膜愈合是国内外溃疡性结肠炎临床指南一致认定的溃疡性结肠炎 治疗目标。溃疡性结肠炎患者尽早实现黏膜愈合，可大幅降低疾病复发率、住院率、结直肠切除手术率 和结直肠癌发生风险。艾曲莫德已被纳入2024年美国胃肠病学协会(AGA)临床实践指南, 推荐作为溃疡 性结肠炎的一线治疗。2025年，艾曲莫德获得2025年美国胃肠病学会(ACG)成人UC临床指南的一线治 疗推荐，进一步印证了 ...

Core Viewpoint - CloudTop New Drug (HKEX 1952.HK) has made significant progress in the commercialization of its innovative drug, Aikumo (维长宁®), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Aikumo has received regulatory approvals in Macau, Singapore, Hong Kong, and has its NDA accepted in South Korea, marking important advancements in its market access across Asia [1] - The National Medical Products Administration of China has also accepted the NDA for Aikumo (维适平®), with expectations for approval by the end of this year or early next year [1] - Aikumo is recognized as a first-line oral treatment for ulcerative colitis, promoting effective mucosal healing and demonstrating good safety profiles [2] Group 2: Clinical Research and Evidence - The NDA application for Aikumo is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002), which showed significant clinical efficacy and safety in patients with moderate to severe active UC [2][3] - The ENLIGHT study is the largest Phase III clinical trial for moderate ulcerative colitis in Asia, involving 340 patients, and demonstrated significant clinical and statistical differences in treatment outcomes [3] Group 3: Market Potential and Strategic Plans - The CEO of CloudTop highlighted the growing number of ulcerative colitis patients in Asia, with approximately 800,000 patients in China expected to rise to 1 million by 2030, indicating a substantial unmet medical need [2] - Aikumo has been included in the list of urgently needed imported drugs and medical devices in the Greater Bay Area for 2024, facilitating its early use in the region [3] - The company has initiated local production of Aikumo at its Jiaxing factory to support supply and commercialization in Greater China and other Asian markets [3]

格隆汇8月11日丨云顶新耀(01952.HK)公布，谨定于2025年8月28日(星期四)举行董事会会议，以考虑及 通过集团截至2025年6月30日止六个月的中期业绩，以及处理其他事项。 ...

於本公告日期，董事會包括主席兼執行董事傅唯先生，執行董事羅永慶先生及何穎先生，非執行 董事曹基哲先生及馮洪剛先生，以及獨立非執行董事徐海音女士、李軼梵先生及蔣世東先生。 （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 董事會會議召開日期 雲頂新耀有限公司（「本公司」及其附屬公司「本集團」）董事會（「董事會」）茲通告謹 定於2025年8月28日（ 星期四 ）舉行董事會會議，以考慮及通過本集團截至2025年 6月30日止六個月的中期業績，以及處理其他事項。 承董事會命 雲頂新耀有限公司 主席兼執行董事 傅唯 香港，2025年8月11日 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。 ...

Core Insights - The article highlights the significant progress made by the Hong Kong-based innovative pharmaceutical company, YunTing New Medicine, with its drug, Naisufang® (Budesonide Enteric-Coated Capsules), which is the first and only fully approved treatment for IgA nephropathy [1][6] - The drug has received approval for a new indication in Taiwan, allowing it to be used for all adult patients at risk of disease progression, thus expanding its patient base and market potential [1][5] Group 1: Market Potential and Demand - IgA nephropathy is the most common primary glomerular disease globally, with a notably higher prevalence in Asian populations, where the risk of progression to end-stage renal disease is 56% higher compared to other populations [2] - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new diagnoses each year, indicating a substantial market demand for effective treatments [2] - The approval of Naisufang® is expected to generate sales of 1 billion yuan in its first full year post-launch, reflecting its strong market potential [1][6] Group 2: Clinical and Regulatory Advancements - Naisufang® has been recognized as a breakthrough therapy by the Chinese National Medical Products Administration (NMPA), filling a significant gap in the treatment of IgA nephropathy [2][4] - The drug's unique mechanism of action, which targets gut mucosal immunity and reduces the production of pathogenic IgA1, has been validated through clinical studies, demonstrating a 50% reduction in kidney function decline [4] - The drug has received dual recommendations from both domestic and international guidelines, solidifying its position as a first-line treatment for IgA nephropathy [4] Group 3: Supply and Production Capacity - The approval for the expansion of Naisufang® production capacity was granted in August, addressing the urgent need to meet the growing market demand [3] - The expansion will ensure a steady supply of the drug across China and the broader Asian region, alleviating the unmet clinical needs for IgA nephropathy treatments [3] Group 4: Commercialization and Market Strategy - YunTing New Medicine has established an efficient commercialization framework, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [6] - The drug's comprehensive approval across multiple regulatory bodies, including the NMPA, FDA, and EMA, enhances its market accessibility and patient coverage in Asia [6] - Analysts predict that Naisufang® could reach peak sales of 5 billion yuan, indicating its potential as a blockbuster product in the nephrology market [6]