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 - 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]

Core Viewpoint - The recent announcement of long-term safety data for VELSIPITY® (Iqumod) in treating moderate to severe active ulcerative colitis (UC) has generated positive market sentiment towards Cloudtop New Horizon (1952.HK), with expectations of significant commercial potential and a peak sales forecast of 5 billion yuan [1][2][5]. Group 1: Clinical Data and Research Findings - The long-term safety study included over 1,000 patients and demonstrated good tolerability and safety for Iqumod, with an adverse event exposure rate of only 1.63 per patient-year over four years [3]. - In a large-scale Phase III clinical trial in Asia, Iqumod achieved a mucosal healing rate of 52% and complete mucosal normalization of 46% after 52 weeks of treatment, providing strong evidence for its application in UC patients [2][4]. - The drug has been recognized in clinical guidelines as a first-line treatment for UC, further validating its clinical value [6]. Group 2: Market Performance and Investor Sentiment - Cloudtop New Horizon's stock has surged over 60% since June, reaching a four-year high, reflecting investor confidence in the company's product pipeline and strategic positioning [2][7]. - CICC has maintained a "outperform" rating for Cloudtop New Horizon and raised its target price to 80 HKD, driven by positive expectations for Iqumod's commercialization potential [2]. Group 3: Regulatory and Commercialization Progress - Iqumod's new drug application (NDA) in mainland China is under review, with expectations for approval by late 2025 to early 2026, which would benefit domestic patients [1][6]. - The drug has already been approved in several Asian regions, including Singapore and Hong Kong, and is set to enhance accessibility for patients in the Greater Bay Area [6]. Group 4: Industry Context and Future Outlook - The increasing prevalence of UC in China, projected to rise from 800,000 patients in 2024 to 1 million by 2030, highlights the significant unmet medical needs and the relevance of Iqumod's clinical research [4]. - The theme of the AOCC 2025 conference emphasizes collaboration in treating inflammatory bowel disease (IBD), with Iqumod's research contributing important clinical evidence towards this goal [5].