Core Insights - The innovative drug Etrasimod (VELSIPITY(R)) from the company has been strongly recommended in the 2025 ACG Clinical Guidelines for the treatment of moderate to severe active Ulcerative Colitis (UC) patients, highlighting its clinical value and potential to meet unmet treatment needs [1][2][3] Group 1: Clinical Guidelines and Recommendations - Etrasimod is recommended for both induction and maintenance therapy in moderate to severe active UC patients, based on moderate quality evidence [1] - The guidelines suggest continuing Etrasimod for patients who have achieved induction remission with S1P receptor modulators, indicating its role in maintaining remission [1] - The guidelines emphasize the importance of achieving endoscopic mucosal healing as a core treatment goal for moderate to severe UC, which is linked to improved long-term management and quality of life for patients [3] Group 2: Clinical Trial Results - The ELEVATE UC III phase registration studies (ELEVATE UC 52 and ELEVATE UC 12) achieved all primary and key secondary endpoints, showing significant improvement in clinical remission rates at 12 weeks and 52 weeks [2] - Notably, 100% of clinical remissions were steroid-free, indicating a favorable safety profile consistent with previous studies [2] - The guidelines also highlight Etrasimod's effectiveness in patients with Ulcerative Proctitis, showing a significant increase in clinical remission rates compared to existing treatments [2] Group 3: Market and Commercialization - The number of UC patients in Asia is rising, with an estimated 800,000 patients in China by 2024, projected to reach 1 million by 2030, indicating a growing need for effective treatment options [4] - The company is accelerating the commercialization process of Etrasimod, aiming to provide long-term effective disease management and improve patient quality of life [4] - Etrasimod's new drug application has been accepted by the Chinese National Medical Products Administration, with expected approval by the end of 2024 or early 2025, and it has already been approved in several regions including Singapore and Hong Kong [4]

Group 1 - The core product of the company, Etrasimod (VELSIPITY), has been included in the "2025 ACG Clinical Guidelines: Adult Ulcerative Colitis" and the 2024 AGA Clinical Practice Guidelines, indicating its recognition in the field [1][1] - Etrasimod's new drug application in China has been accepted by the National Medical Products Administration, with expectations for approval between late 2025 and early 2026 [1][1] - The recommendation of Etrasimod in the new guidelines reflects its clinical value and efficacy, as stated by a leading researcher in the Asia-Pacific region [1][1] Group 2 - To ensure post-launch supply, the company has initiated a production project at its factory in Jiaxing, Zhejiang, with a total investment of 70 million yuan, aiming for an annual production capacity of 50 million tablets [2][2] - The production will meet the demand in the Chinese and Asian markets [2]

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].