Core Insights - The innovative drug Etrasimod (VELSIPITY) developed by the company for treating moderate to severe active ulcerative colitis (UC) has shown promising results in the ENLIGHT UC Phase III clinical study, published in The Lancet Gastroenterology & Hepatology [1][2] - The study demonstrated a mucosal healing rate of 51.9% and a complete normalization rate of 45.5% after 52 weeks of treatment, significantly higher than the current 24% rate among patients achieving mucosal healing [1][3] - Etrasimod is anticipated to reach peak sales of 5 billion yuan, positioning it as a key product alongside the company's existing offerings in the autoimmune disease sector [1][5] Study Details - The ENLIGHT UC study was a multicenter, randomized, double-blind, placebo-controlled trial involving 340 patients who had previously failed or were intolerant to standard treatments for UC [2][3] - Results indicated statistical significance and clinical relevance across all primary and secondary efficacy endpoints during both the 12-week induction and 40-week maintenance phases [2] Clinical and Market Implications - The increasing prevalence of UC in Asia, with an estimated 800,000 patients in China by 2024 projected to rise to nearly 1.5 million by 2031, highlights the urgent clinical need for effective treatments [3][4] - Etrasimod's mechanism as a high-selectivity oral S1P receptor modulator aligns with the core treatment needs for UC, offering advantages such as rapid onset of action and deep mucosal healing [4][5] - The drug has been recognized in clinical guidelines, being recommended as a first-line treatment for UC by the American Gastroenterological Association and the American College of Gastroenterology [4][5] Commercialization Progress - Etrasimod has received approvals in regions such as Macau, Singapore, and Hong Kong, with new drug applications (NDA) accepted in Taiwan and South Korea [5] - The company has initiated local production in Zhejiang, aiming for an annual capacity of 50 million tablets to ensure supply [5] - The NDA for Etrasimod in mainland China is expected to be approved by mid-2026, which will benefit domestic patients [5]
云顶新耀艾曲莫德登《柳叶刀》子刊：黏膜愈合率突破51.9%，商业化进程同步推进