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]