Core Insights - The core product of the innovative drug company Cloudtop New Medicine, Weishiping (Arginine Acquimod Tablets), has received approval from the National Medical Products Administration of China for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients who have insufficient response, loss of response, or intolerance to traditional therapies or biological agents [1][2] Group 1: Product Approval and Clinical Efficacy - Weishiping is administered orally once daily and is designed to achieve rapid onset and strong deep mucosal healing, providing a new first-line treatment option for adult patients with ulcerative colitis [1] - Clinical trials have shown significant efficacy for Weishiping, particularly in rapid onset, achieving steroid-free remission, and deep mucosal healing [1] - The ENLIGHT UC study, a multi-center phase III trial in Asia, reported a clinical remission rate of 48.1%, a mucosal healing rate of 51.9%, and an endoscopic normalization rate of 45.5% after 40 weeks of maintenance treatment, with good safety and tolerability [1] Group 2: Market Impact and Future Plans - The approval of Weishiping fills an important gap in the treatment of moderate to severe ulcerative colitis and offers a new option for innovative oral therapies aimed at deep mucosal healing [2] - The company plans to accelerate the commercialization process of Weishiping and actively promote its inclusion in the national medical insurance catalog to enhance the accessibility and affordability of innovative therapies in China, benefiting more patients [2]
云顶新耀：溃疡性结肠炎创新口服药物维适平获批上市