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].

Core Insights - Yunding Xinyao's core product, Etrasimod (VELSIPITY), has been included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis, receiving strong recommendations for induction and maintenance therapy in moderate to severe active UC patients [1][2] - The inclusion in both the ACG and AGA guidelines highlights Etrasimod's clinical value and its potential to fill treatment gaps in ulcerative colitis [1][2] Clinical Efficacy and Safety - Etrasimod is a next-generation S1P receptor modulator that retains activated lymphocytes in lymph nodes, reducing their infiltration in the gut and local inflammation, demonstrating unique advantages in efficacy and safety [2] - The ELEVATE UC III phase studies showed significant improvements in clinical remission rates at 12 weeks (43.2% for Etrasimod vs. 13.6% for control, p<0.001) and sustained endoscopic mucosal healing [2][3] - Long-term safety data from global studies indicate a low adverse event rate of 1.63 per patient-year, confirming Etrasimod's good tolerability over four years [4] Market Potential and Commercialization - The prevalence of ulcerative colitis is increasing, with an estimated 800,000 patients in China by 2024, projected to rise to 1 million by 2030, providing a substantial market opportunity for Etrasimod [5][6] - Etrasimod is expected to receive regulatory approval in Macau, Singapore, and Hong Kong in 2024, with applications in mainland China and other regions under review, indicating an accelerated commercialization process [6] - The company plans to invest 70 million yuan in a production facility in Zhejiang, aiming for an annual capacity of 50 million tablets to meet market demand [6] - Industry forecasts suggest Etrasimod's peak sales could reach 5 billion yuan, significantly contributing to the company's revenue growth [6] Strategic Goals - Yunding Xinyao is advancing its portfolio in nephrology, infectious diseases, and mRNA technology, aiming for 10 billion yuan in sales by 2030 [7] - The company is positioning itself as a leading biopharmaceutical enterprise in Asia, driven by the commercialization of Etrasimod and its innovative drug pipeline [7]

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]