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 - 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 - Cloud-based innovative pharmaceutical company, Yunding Xinyao (1952.HK), has made significant progress in the market access of its key product for autoimmune diseases, with the Taiwan FDA officially accepting the New Drug Application (NDA) for Aiqumote (维长宁) for treating moderate to severe active ulcerative colitis (UC) patients [1] Group 1: Product Development and Market Access - The NDA for Aiqumote was formally accepted by the National Medical Products Administration (NMPA) in mainland China in December 2024, with expectations for approval by the end of this year or early next year [1] - The acceptance of the NDA in Taiwan further strengthens the commercial layout of Aiqumote in Asia, laying a solid foundation for future market entries in more Asian countries [1] - Industry forecasts suggest that Aiqumote's peak sales could reach 5 billion yuan, positioning it as the next major product following Nairfukang (布地奈德肠溶胶囊) [1] Group 2: Clinical Need and Treatment Landscape - Ulcerative colitis is a chronic, recurrent inflammatory bowel disease with a complex pathogenesis and significant treatment challenges, leading to increased disability and colorectal cancer rates among patients [2] - In China, the number of ulcerative colitis patients is projected to grow from approximately 800,000 in 2024 to 1 million by 2030, highlighting a substantial unmet clinical need [2] - Current treatment options are limited, with existing medications, including JAK inhibitors, carrying serious risks such as severe infections and malignancies, prompting the FDA to issue black box warnings [2] Group 3: Efficacy and Safety of Aiqumote - Aiqumote is an oral first-line treatment for ulcerative colitis, demonstrating strong efficacy in achieving mucosal healing and offering good safety profiles [2] - Recent data from the 13th Asian Organization for Crohn's and Colitis (AOCC 2025) annual meeting confirmed Aiqumote's long-term safety and tolerability, reinforcing its advantages as an innovative therapy for moderate to severe UC [2][3] - Aiqumote has been included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for ulcerative colitis, further validating its clinical value [3] Group 4: Clinical Research and Evidence - The NDA application for Aiqumote is based on results from the ELEVATE UC Phase III registration studies, which demonstrated superior and sustained clinical remission and mucosal healing at both 12 and 52 weeks [3][4] - The ENLIGHT study, the largest Phase III clinical trial for moderate ulcerative colitis in Asia, reported a 52% mucosal healing rate and a 46% complete normalization rate after 52 weeks, providing strong evidence for Aiqumote's application in Asian patients [4] Group 5: Local Production and Market Expansion - Yunding Xinyao is advancing the local production of Aiqumote, with a production facility in Jiaxing set to support supply after its launch in mainland China [5] - Aiqumote has already been approved for sale in Singapore, Macau, and Hong Kong, with a listing application in South Korea accepted in June this year [4]

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]

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]

Group 1 - The core point of the news is that Cloudtop New Horizon (01952.HK) has received acceptance from Taiwan's drug regulatory authority for the new drug application of Aicmod (维长宁) for treating moderate to severe active ulcerative colitis (UC) patients, marking a significant step in its market entry in Asia [1] - Aicmod has already been approved in Macau, Singapore, and Hong Kong, with South Korea also accepting its new drug application. The National Medical Products Administration of China has accepted the application for Aicmod, with approval expected by the end of this year or early next year [1] - The number of ulcerative colitis patients in China is projected to reach 1 million by 2030, with a current estimate of 800,000 in 2024, indicating a growing unmet medical need in the region [1] Group 2 - Aicmod is recognized as a first-line oral treatment for ulcerative colitis, demonstrating strong efficacy in achieving mucosal healing and good safety profiles based on the results of the ELEVATE UC Phase III studies [2] - The ENLIGHT study, the largest Phase III clinical trial for moderate ulcerative colitis in Asia, showed significant clinical and statistical differences in treatment outcomes, supporting Aicmod's application in this patient population [2] - Aicmod has been included in the list of urgently needed imported drugs in the Guangdong-Hong Kong-Macao Greater Bay Area, and local production is set to begin in March 2025 to support commercialization in Greater China and other Asian markets [3] Group 3 - The market potential for Aicmod is widely regarded as promising, with industry forecasts predicting peak sales could reach 5 billion yuan, making it a key driver of the company's revenue growth [3]

Core Viewpoint - CloudTop New Drug (01952) has made significant progress in the commercialization of its innovative drug, Eiqumod (维长宁), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Eiqumod has received regulatory approvals in Macau, Singapore, Hong Kong, and its NDA has been accepted in South Korea, marking important advancements in its market access across Asia [1] - The drug is expected to receive approval from the National Medical Products Administration (NMPA) in China by the end of 2024 or early 2025 [1] - Eiqumod is recognized as a first-line oral treatment that effectively promotes mucosal healing in UC patients, which is a key treatment goal according to clinical guidelines [1][2] Group 2: Clinical Research and Efficacy - The NDA application for Eiqumod is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC52 and ELEVATE UC12) and the ENLIGHT study (ES101002), which demonstrated significant clinical efficacy and safety [2][3] - The ELEVATE UC studies showed that Eiqumod achieved both clinical remission and deep mucosal healing at 12 and 52 weeks, with 100% of clinical remission being steroid-free [2] - The ENLIGHT study is the largest Phase III clinical trial for moderate UC in Asia, involving 340 patients, and provided strong evidence for the drug's application in this patient population [3] Group 3: Market Potential and Strategic Initiatives - The CEO of CloudTop highlighted the growing number of UC patients in Asia, with an estimated 800,000 patients in China in 2024, projected to reach 1 million by 2030, indicating a significant unmet medical need [2] - Eiqumod has been included in the urgent import drug list for the Greater Bay Area in 2024, allowing for early access to patients in that region [3] - The company has initiated local production of Eiqumod in its Jiaxing facility to support supply and commercialization in Greater China and other Asian markets [3][4] Group 4: Company Overview - CloudTop New Drug focuses on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, aiming to meet unmet medical needs in the Asian market [5] - The management team has extensive experience in high-quality research and development, regulatory affairs, and commercialization operations within leading pharmaceutical companies [5]

Core Insights - CloudTop New Horizon (云顶新耀) has made significant progress in the commercialization of its innovative drug, Ecurmod (维长宁®), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] - Ecurmod has been recognized as a first-line oral treatment that effectively promotes mucosal healing, which is a key treatment goal for UC, and has been included in clinical practice guidelines by the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) [2][3] - The company aims to accelerate the drug's market entry in mainland China and other Asian markets to meet the growing demand for UC treatment, with an estimated 800,000 UC patients in China by 2024, projected to reach 1 million by 2030 [2][3] Company Overview - CloudTop New Horizon is a biopharmaceutical company focused on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, addressing unmet medical needs in the Asian market [5] - The management team possesses extensive expertise and experience in high-quality research and development, clinical development, regulatory affairs, and commercialization operations, having worked with leading pharmaceutical companies globally [5] - Ecurmod is a high-selectivity sphingosine-1-phosphate (S1P) receptor modulator, designed to bind with S1P receptors 1, 4, and 5, and has received marketing approval in multiple regions including the US, EU, Canada, Japan, Australia, and several Asian markets [4]

Core Viewpoint - CloudTop New Drug (HKEX 1952.HK) has made significant progress in the commercialization of its innovative drug, Aikumo (维长宁®), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Aikumo has received regulatory approvals in Macau, Singapore, Hong Kong, and has its NDA accepted in South Korea, marking important advancements in its market access across Asia [1] - The National Medical Products Administration of China has also accepted the NDA for Aikumo (维适平®), with expectations for approval by the end of this year or early next year [1] - Aikumo is recognized as a first-line oral treatment for ulcerative colitis, promoting effective mucosal healing and demonstrating good safety profiles [2] Group 2: Clinical Research and Evidence - The NDA application for Aikumo is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002), which showed significant clinical efficacy and safety in patients with moderate to severe active UC [2][3] - The ENLIGHT study is the largest Phase III clinical trial for moderate ulcerative colitis in Asia, involving 340 patients, and demonstrated significant clinical and statistical differences in treatment outcomes [3] Group 3: Market Potential and Strategic Plans - The CEO of CloudTop highlighted the growing number of ulcerative colitis patients in Asia, with approximately 800,000 patients in China expected to rise to 1 million by 2030, indicating a substantial unmet medical need [2] - Aikumo has been included in the list of urgently needed imported drugs and medical devices in the Greater Bay Area for 2024, facilitating its early use in the region [3] - The company has initiated local production of Aikumo at its Jiaxing factory to support supply and commercialization in Greater China and other Asian markets [3]

格隆汇8月11日丨云顶新耀(01952.HK)公布，谨定于2025年8月28日(星期四)举行董事会会议，以考虑及 通过集团截至2025年6月30日止六个月的中期业绩，以及处理其他事项。 ...