Group 1: Drug Approval and Market Expansion - Cloud-based innovative drug company, Yunding Xinyao (1952.HK), has received acceptance for its new drug application (NDA) for Etrasimod (VELSIPITY) for treating moderate to severe active ulcerative colitis (UC) patients from the Korean Ministry of Food and Drug Safety (MFDS), marking a significant step in its Asian market entry [1] - Etrasimod has already been approved in Macau, Singapore, and Hong Kong, with its application in mainland China also accepted, indicating a comprehensive market strategy in Asia [1][5] - The acceptance of the NDA in Korea brings Yunding Xinyao closer to a full market presence in Asia [1] Group 2: Clinical Data and Unmet Needs - Ulcerative colitis is recognized as a modern refractory disease by the World Health Organization, with a significant unmet need in Asia as the number of patients continues to rise [2] - In 2022, approximately 600,000 patients in China were diagnosed with ulcerative colitis, expected to reach 1 million by 2030, while South Korea's patient count is projected to exceed 80,000 by 2030 [2] - Etrasimod is a next-generation selective S1P receptor modulator that shows superior efficacy in achieving deep mucosal healing, which is crucial for reducing disease recurrence and associated risks [2][3] Group 3: Clinical Trials and Efficacy - The NDA application for Etrasimod is based on the results of the ELEVATE UC Phase III registration studies, which included patients who had failed or were intolerant to at least one conventional treatment [3] - The studies demonstrated significant clinical remission and mucosal healing rates, with a 52-week mucosal healing rate of 52% and complete normalization of mucosa at 46% [4] - The clinical value of Etrasimod has been recognized, being included in the 2024 American Gastroenterological Association (AGA) clinical practice guidelines as a first-line treatment for ulcerative colitis [2][3] Group 4: Commercial Potential and Production - Yunding Xinyao has exclusive rights to develop, manufacture, and commercialize Etrasimod in Greater China and South Korea since 2017, with plans for local production to support market needs [5][6] - The company has initiated a production project in Jiaxing, with an investment of 70 million yuan, expected to yield an annual capacity of 50 million tablets, enhancing market potential [6] - Etrasimod is anticipated to reach peak sales of 5 billion yuan, contributing significantly to Yunding Xinyao's product line, alongside other key products [6]
云顶新耀(1952.HK)伊曲莫德韩国上市申请获受理 距离亚洲市场全面布局再近一步
Ge Long Hui·2025-06-25 00:16