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 - The article highlights the strong recommendation of Etrasimod (VELSIPITY®) for the treatment of moderate to severe active ulcerative colitis (UC) in the newly released 2025 ACG Clinical Guidelines, indicating its clinical value and potential to fill a treatment gap in UC [1][2][3] Group 1: Clinical Value and Research Support - Etrasimod is recognized as a new generation S1P receptor modulator, with a mechanism that retains activated lymphocytes in lymph nodes, reducing their infiltration in the gut and local inflammation, showcasing unique advantages in efficacy and safety [2][3] - The ELEVATE UC III phase registration studies (ELEVATE UC 52 and ELEVATE UC 12) demonstrated significant improvements in clinical remission rates at both 12 weeks and 52 weeks, with 100% of clinical remissions being steroid-free [2][4] - The clinical remission rate for the Etrasimod group at 12 weeks was 43.2%, significantly higher than the control group's 13.6% (p<0.001) [2][3] Group 2: Market Potential and Commercialization - The Asian market for ulcerative colitis is expanding, with an estimated 800,000 patients in China by 2024, projected to reach 1 million by 2030, providing a substantial commercial opportunity for Etrasimod [6] - Etrasimod's commercialization in Asia is accelerating, with approvals expected in Macau, Singapore, and Hong Kong in 2024, and applications submitted in South Korea and Taiwan [6] - The company plans to start production at its Zhejiang Jiaxing factory in March 2025, with an investment of 70 million yuan, aiming for an annual capacity of 50 million tablets to meet market demand [6] Group 3: Strategic Positioning and Future Goals - Etrasimod is viewed as the next blockbuster product for the company, with sales potential estimated to reach 5 billion yuan [7] - The company aims to achieve 10 billion yuan in sales by 2030, supported by a diverse pipeline in nephrology, infectious diseases, and mRNA technology [7] - The management team has extensive global pharmaceutical experience, positioning the company towards becoming a leading comprehensive biopharmaceutical enterprise in Asia [7]