云顶新耀：维适平 用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批

Core Insights - The approval of Velsipity (Arginine Acumod Tablets) by the NMPA marks a significant milestone for the company in establishing its leading position in the autoimmune field [1][3] - Velsipity is a new generation high-selectivity S1P receptor modulator that offers a new first-line treatment option for adult patients with moderate to severe active ulcerative colitis [2] - The company aims to commercialize Velsipity quickly and push for its inclusion in the national medical insurance directory as part of its 2030 development strategy [3] Clinical Research - The approval is based on results from the ENLIGHT UC study, the largest Phase III registration clinical trial for moderate to severe active ulcerative colitis patients in Asia, involving 340 patients [2] - Velsipity demonstrated statistical significance and clinical relevance in all primary and secondary efficacy endpoints during the 12-week induction and 40-week maintenance treatment periods [2] - The ELEVATE UC Phase III studies further validated Velsipity's favorable benefit-risk profile [2] Commercialization Strategy - The company has laid out plans to establish a comprehensive commercialization system and aims to achieve revenue exceeding 10 billion RMB by 2028 and over 15 billion RMB by 2030 [4] - The revenue growth rate is projected to exceed 50% from 2025 to 2030, with a target of maintaining over 15% growth post-2030 [4] - The number of commercialized products is expected to increase to over 20, including Velsipity and other key products [4] Future Development Plans - The 2030 development strategy signifies a crucial milestone for the company in advancing towards the forefront of global biopharmaceuticals [5] - The company plans to introduce 3 to 5 late-stage blockbuster products annually and aims to contribute 6 billion RMB in revenue from over 20 high-value assets by 2030 [5] - The strategic focus will be on maintaining leadership in core therapeutic areas and innovative drug development, aiming to become a leading comprehensive biopharmaceutical company globally [5]