Core Viewpoint - The Hong Kong innovative pharmaceutical sector has seen a significant increase in refinancing activities in 2025, with over 20 companies participating, raising more than 34 billion HKD, which is substantially higher than the same period last year [1][2]. Group 1: Financing Activities - As of August 20, 2025, Hansoh Pharmaceutical announced a plan to raise 3.9 billion HKD through a rights issue, marking its third refinancing since listing [2]. - The total refinancing amount for Hong Kong innovative pharmaceutical companies has exceeded 34 billion HKD, with some companies conducting multiple rounds of refinancing [2][5]. - WuXi AppTec has raised the highest amount in this refinancing wave, securing nearly 7.7 billion HKD through a placement of new shares [7]. Group 2: Comparison with A-Shares - In contrast, only two A-share innovative pharmaceutical companies have been approved for refinancing this year: Dizal Pharmaceutical raised approximately 1.8 billion HKD in April, and Baillie Tianheng's 3.9 billion HKD plan was approved in early August [5]. Group 3: Shareholder Actions - Some founders and major shareholders of innovative pharmaceutical companies are taking the opportunity to reduce their holdings and cash out [6][13]. - Notable reductions include the founders of BeiGene, who have sold shares worth over 70 million USD in the U.S. market since the beginning of the year [13]. - Temasek, the largest shareholder of Innovent Biologics, has reduced its stake three times, cashing out over 2.4 billion HKD [14]. Group 4: Innovative Financing Methods - Several companies are utilizing "old-for-new" financing methods, where founders sell their old shares to new investors and use the cash to subscribe to newly issued shares, making it more attractive for investors [9][10]. - For instance, Ascentage Pharma raised 1.5 billion HKD through this method, coinciding with the approval of its second drug [10]. Group 5: Market Trends - The innovative pharmaceutical sector has experienced a surge in stock prices, with many companies actively seeking financing to support future growth [13]. - Innovent Biologics has seen its stock price increase by over 2.5 times since the beginning of the year, while WuXi AppTec's stock price is close to its historical high [14].

Core Viewpoint - CloudTop New Horizon (01952) saw a significant stock increase of over 5%, closing at 73.35 HKD with a trading volume of 499 million HKD, following the announcement of its core product, Aicromod, being included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis [1] Group 1: Product Development and Recognition - Aicromod has been strongly recommended for the induction and maintenance treatment of moderate to severe active Ulcerative Colitis (UC) patients in the newly released guidelines [1] - The product was previously included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for Ulcerative Colitis, highlighting its clinical value and potential to fill treatment gaps [1] Group 2: Strategic Investments - CloudTop New Horizon announced a strategic investment of 30.9 million USD in Tianjing Bio, increasing its ownership stake to 16.1%, making it the largest shareholder [1] - According to CMB International, this strategic investment allows the company to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical transformation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1]

Core Viewpoint - CloudTop New Horizon (01952) saw a significant stock increase of over 5%, closing at HKD 73.35 with a trading volume of HKD 499 million, following the announcement of its core product, Aikumo, being included in the 2025 ACG Clinical Guidelines for Ulcerative Colitis [1] Group 1: Product Development and Recognition - Aikumo has been strongly recommended for the induction and maintenance treatment of moderate to severe active ulcerative colitis (UC) patients in the newly released guidelines [1] - The product was previously included in the 2024 AGA Clinical Practice Guidelines, marking it as a first-line treatment for ulcerative colitis [1] - The dual endorsement from two major international guidelines underscores Aikumo's clinical value and its potential to fill a treatment gap in ulcerative colitis [1] Group 2: Strategic Investment - CloudTop New Horizon announced a strategic investment of USD 30.9 million in Tianjing Bio, increasing its ownership stake to 16.1%, making it the largest shareholder [1] - According to CMB International, this strategic investment allows the company to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1]

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 - 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]