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]
云顶新耀(1952.HK)宣布中国台湾地区药政部门正式受理维长宁®（艾曲莫德）用于治疗中重度活动性溃疡性结肠炎的新药上市许可申请