Group 1 - The core point of the news is that Cloudtop New Horizon (01952.HK) has received acceptance from Taiwan's drug regulatory authority for the new drug application of Aicmod (维长宁) for treating moderate to severe active ulcerative colitis (UC) patients, marking a significant step in its market entry in Asia [1] - Aicmod has already been approved in Macau, Singapore, and Hong Kong, with South Korea also accepting its new drug application. The National Medical Products Administration of China has accepted the application for Aicmod, with approval expected by the end of this year or early next year [1] - The number of ulcerative colitis patients in China is projected to reach 1 million by 2030, with a current estimate of 800,000 in 2024, indicating a growing unmet medical need in the region [1] Group 2 - Aicmod is recognized as a first-line oral treatment for ulcerative colitis, demonstrating strong efficacy in achieving mucosal healing and good safety profiles based on the results of the ELEVATE UC Phase III studies [2] - The ENLIGHT study, the largest Phase III clinical trial for moderate ulcerative colitis in Asia, showed significant clinical and statistical differences in treatment outcomes, supporting Aicmod's application in this patient population [2] - Aicmod has been included in the list of urgently needed imported drugs in the Guangdong-Hong Kong-Macao Greater Bay Area, and local production is set to begin in March 2025 to support commercialization in Greater China and other Asian markets [3] Group 3 - The market potential for Aicmod is widely regarded as promising, with industry forecasts predicting peak sales could reach 5 billion yuan, making it a key driver of the company's revenue growth [3]
云顶新耀艾曲莫德新药上市申请在中国台湾获得受理