智通财经APP获悉，云顶新耀(01952)是一家专注于创新药研发、临床开发、制造和商业化的生物制药公 司，近日宣布中国台湾地区药政主管部门(TFDA)已正式受理维长宁®(艾曲莫德，中国台湾地区商品 名：維長寧®)用于治疗中重度活动性溃疡性结肠炎(UC)患者的新药上市许可申请(NDA)。此次受理标志 着艾曲莫德继中国澳门、新加坡和中国香港获批和韩国NDA获正式受理之后，其在亚洲市场的准入取 得重要进展。中国国家药品监督管理局也于2024年12月正式受理艾曲莫德(维适平®)的新药上市申请， 预计今年年底或明年年初获批。 艾曲莫德是一款针对溃疡性结肠炎，每日一次的口服一线治疗药物，能够强效实现肠道黏膜愈合，且使 用便捷，并具有良好的安全性特征。黏膜愈合是国内外溃疡性结肠炎临床指南一致认定的溃疡性结肠炎 治疗目标。溃疡性结肠炎患者尽早实现黏膜愈合，可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。2025年，艾曲莫德获得2025年美国胃肠病学会(ACG)成人UC临床指南的一线治 疗推荐，进一步印证了 ...

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]