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].