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 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]