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].