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]

Core Viewpoint - Cloudtop New Horizon Pharmaceutical Technology Co., Ltd. announced that Etrasimod (VELSIPITY®) has been included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis, strongly recommending its use for induction and maintenance therapy in patients with moderate to severe active ulcerative colitis [1][2]. Group 1: Clinical Guidelines and Recommendations - The new guidelines, developed by the American College of Gastroenterology (ACG), summarize the latest evidence-based medicine over the past five years regarding treatment and prevention of complications in ulcerative colitis [1]. - Etrasimod is recognized as a next-generation highly selective S1P receptor modulator, which works by retaining activated lymphocytes in lymph nodes, thereby reducing their infiltration in the gut and lowering local inflammatory responses [1][2]. - Etrasimod has also been included in the 2024 AGA clinical practice guidelines as a first-line treatment for ulcerative colitis [1]. Group 2: Market and Production Plans - Under the "Hong Kong-Macao Drug and Device" policy, Etrasimod has been approved for use in nine cities in the Guangdong-Hong Kong-Macao Greater Bay Area as an urgently needed imported drug [2]. - The new drug application for Etrasimod in mainland China was accepted by the National Medical Products Administration in December 2024, with approval expected between the end of 2025 and early 2026 [2]. - To ensure supply post-approval, Cloudtop New Horizon plans to start production at its factory in Jiaxing, Zhejiang, in March 2025, with a total investment of 70 million yuan and an expected annual production capacity of 50 million tablets [2]. Group 3: Expert Opinions - Professor Wu Kaichun, a leading researcher in the Asia-Pacific clinical trial for Etrasimod, emphasized that the new guidelines clarify the core goal of treatment for moderate to severe ulcerative colitis as achieving endoscopic mucosal healing for sustained steroid-free remission [2]. - The CEO of Cloudtop New Horizon highlighted that the strong recommendation of Etrasimod in the new guidelines reflects its excellent clinical efficacy and safety, establishing its important position as a new first-line treatment option for moderate to severe ulcerative colitis [2].

Group 1: Drug Approval and Market Expansion - Cloud-based innovative drug company, Yunding Xinyao (1952.HK), has received acceptance for its new drug application (NDA) for Etrasimod (VELSIPITY) for treating moderate to severe active ulcerative colitis (UC) patients from the Korean Ministry of Food and Drug Safety (MFDS), marking a significant step in its Asian market entry [1] - Etrasimod has already been approved in Macau, Singapore, and Hong Kong, with its application in mainland China also accepted, indicating a comprehensive market strategy in Asia [1][5] - The acceptance of the NDA in Korea brings Yunding Xinyao closer to a full market presence in Asia [1] Group 2: Clinical Data and Unmet Needs - Ulcerative colitis is recognized as a modern refractory disease by the World Health Organization, with a significant unmet need in Asia as the number of patients continues to rise [2] - In 2022, approximately 600,000 patients in China were diagnosed with ulcerative colitis, expected to reach 1 million by 2030, while South Korea's patient count is projected to exceed 80,000 by 2030 [2] - Etrasimod is a next-generation selective S1P receptor modulator that shows superior efficacy in achieving deep mucosal healing, which is crucial for reducing disease recurrence and associated risks [2][3] Group 3: Clinical Trials and Efficacy - The NDA application for Etrasimod is based on the results of the ELEVATE UC Phase III registration studies, which included patients who had failed or were intolerant to at least one conventional treatment [3] - The studies demonstrated significant clinical remission and mucosal healing rates, with a 52-week mucosal healing rate of 52% and complete normalization of mucosa at 46% [4] - The clinical value of Etrasimod has been recognized, being included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for ulcerative colitis [2][3] Group 4: Commercial Potential and Production - Yunding Xinyao has exclusive rights to develop, manufacture, and commercialize Etrasimod in Greater China and South Korea since 2017, with plans for local production to support market needs [5][6] - The company has initiated a production project in Jiaxing, with an investment of 70 million yuan, expected to yield an annual capacity of 50 million tablets, enhancing market potential [6] - Etrasimod is anticipated to reach peak sales of 5 billion yuan, contributing significantly to Yunding Xinyao's product line, alongside other key products [6]