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].

值得注意的是，云顶新耀近日宣布，将向天境生物注资3090万美元，交易完成后，其持股比例为 16.1%，跃升为后者第一大股东。交银国际认为，通过此次战略投资，公司有机会利用天境差异化的4- 1BB平台、双抗管线及海外临床转化能力，与其现有的mRNA肿瘤疫苗布局形成协同。 云顶新耀(01952)尾盘涨超5%，截至发稿，涨4.86%，报73.35港元，成交额4.99亿港元。 消息面上，8月15日，云顶新耀宣布，其核心产品艾曲莫德被纳入《2025 ACG临床指南：成人溃疡性结 肠炎》，新版指南强烈推荐艾曲莫德用于中重度活动性溃疡性结肠炎(UC)患者的诱导缓解治疗及维持 缓解治疗。此前，艾曲莫德已被纳入2024年美国胃肠病学协会(AGA)临床实践指南，推荐作为溃疡性结 肠炎的一线治疗。连续获得两大国际权威指南背书，不仅印证了其临床价值，也凸显其填补溃疡性结肠 炎治疗空白的潜力。 本文源自：智通财经网 ...

值得注意的是，云顶新耀近日宣布，将向天境生物注资3090万美元，交易完成后，其持股比例为 16.1%，跃升为后者第一大股东。交银国际认为，通过此次战略投资，公司有机会利用天境差异化的4- 1BB平台、双抗管线及海外临床转化能力，与其现有的mRNA肿瘤疫苗布局形成协同。 消息面上，8月15日，云顶新耀宣布，其核心产品艾曲莫德被纳入《2025ACG临床指南：成人溃疡性结 肠炎》，新版指南强烈推荐艾曲莫德用于中重度活动性溃疡性结肠炎(UC)患者的诱导缓解治疗及维持 缓解治疗。此前，艾曲莫德已被纳入2024年美国胃肠病学协会(AGA)临床实践指南，推荐作为溃疡性结 肠炎的一线治疗。连续获得两大国际权威指南背书，不仅印证了其临床价值，也凸显其填补溃疡性结肠 炎治疗空白的潜力。 云顶新耀(01952)尾盘涨超5%，截至发稿，涨4.86%，报73.35港元，成交额4.99亿港元。 ...

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]

此次新版指南由美国胃肠病学会（American College of Gastroenterology，ACG）制定，基于近五年来最 新的循证医学证据，系统总结了溃疡性结肠炎在治疗和并发症预防方面的新方法与新进展。 艾曲莫德作为新一代高选择性S1P受体调节剂，新版指南指出，其作用机制为将活化的淋巴细胞滞留于 淋巴结中，从而减少其在肠道中的浸润，降低局部炎症反应，并伴随外周循环淋巴细胞计数下降。这一 精准作用机制使其在疗效与安全性上展现出独特优势。 其临床价值得到了ELEVATE UC III期注册研究（ELEVATE UC 52和ELEVATE UC 12）的有力支撑。这 两项随机、双盲、安慰剂对照研究均达到了所有主要和关键次要终点，分别在第12周和第52周显著改善 临床缓解率，并实现持久的内镜下深度黏膜愈合。值得一提的是，研究中100%的临床缓解均为无激素 缓解，安全性良好，与既往研究结果一致。 值得关注的是，新版指南特别强调了艾曲莫德在溃疡性直肠炎治疗中的突破。临床数据显示，治疗12周 时，艾曲莫德组临床缓解率达43.2%，显著高于对照组的13.6%（p＜0.001）。 8月15日，港股创新药企云顶新耀（ ...

针对亚洲人群，云顶新耀还完成了ENLIGHT研究(ES101002)，这是迄今为止完成的最大规模的亚洲中 重度溃疡性结肠炎的III期注册临床研究。结果显示，诱导期和维持期的治疗均取得了显著临床和统计学 差异的结果，为艾曲莫德在亚洲中重度活动性UC患者中的应用提供了强有力的证据支持。 作为云顶新耀自身免疫性疾病领域的核心产品，艾曲莫德已成为公司第三款商业化新药。2024年，该药 物被纳入粤港澳大湾区内地9市临床急需进口港澳药品医疗器械目录，已在大湾区先行使用。2025年3 月，云顶新耀启动艾曲莫德在嘉善工厂的本地化生产建设项目，支持其在大中华区及其他亚洲市场的供 应及商业化落地。 基于艾曲莫德的独特临床优势以及亚洲市场布局，伊曲莫德的市场潜力被广泛看好。结合UC市场规 模、竞争格局及药物自身的临床优势，业内预测其销售峰值有望达到50亿元，将成为驱动公司业绩增长 的重要力量。 在治疗方面，国内外指南一致认定，溃疡性结肠炎的治疗目标是诱导并维持临床缓解、促进黏膜愈合、 防止并发症及改善生存质量。患者若能尽早实现黏膜愈合，将大幅降低疾病复发率、住院率、结直肠切 除手术率和结直肠癌发生风险。 艾曲莫德作为一款针对溃疡性 ...