Core Insights - CloudTop New Horizon (云顶新耀) has made significant progress in the commercialization of its innovative drug, Ecurmod (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] - Ecurmod has been recognized as a first-line oral treatment that effectively promotes mucosal healing, which is a key treatment goal for UC, and has been included in clinical practice guidelines by the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) [2][3] - The company aims to accelerate the drug's market entry in mainland China and other Asian markets to meet the growing demand for UC treatment, with an estimated 800,000 UC patients in China by 2024, projected to reach 1 million by 2030 [2][3] Company Overview - CloudTop New Horizon is a biopharmaceutical company focused on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, addressing unmet medical needs in the Asian market [5] - The management team possesses extensive expertise and experience in high-quality research and development, clinical development, regulatory affairs, and commercialization operations, having worked with leading pharmaceutical companies globally [5] - Ecurmod is a high-selectivity sphingosine-1-phosphate (S1P) receptor modulator, designed to bind with S1P receptors 1, 4, and 5, and has received marketing approval in multiple regions including the US, EU, Canada, Japan, Australia, and several Asian markets [4]
云顶新耀(01952)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