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].

Core Viewpoint - The approval of Etrasimod (VELSIPITY®) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients by the Hong Kong Department of Health marks a significant milestone for the company, following approvals in Macau and Singapore, and highlights the growing clinical demand in the region [1][2]. Group 1: Product Approval and Clinical Significance - Etrasimod has received formal approval for marketing in Hong Kong, making it the third region within the company's authorized area to approve the drug [1]. - The approval is based on the results of the ELEVATE UC Phase III registration studies, which met all primary and key secondary endpoints, demonstrating consistent safety profiles with previous studies [1]. - Etrasimod has been included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for ulcerative colitis [1]. Group 2: Market Potential and Strategic Plans - The number of ulcerative colitis patients in China was approximately 600,000 in 2022, projected to reach 1 million by 2030, indicating a significant unmet clinical need [2]. - The company aims to enhance the accessibility of this innovative drug and is accelerating the approval process for Etrasimod in mainland China [2]. - Etrasimod has been commercialized in Singapore and Macau, and it is included in the urgent import drug directory for the Guangdong-Hong Kong-Macao Greater Bay Area [3]. Group 3: Clinical Research and Development - The Phase III clinical trial for Etrasimod in Asia is the largest of its kind, involving 340 patients with moderate to severe ulcerative colitis, showing positive results in both induction and maintenance phases [3]. - The company has initiated the construction of a production facility in Jiaxing to support local manufacturing of Etrasimod [3].