中国批准VELSIPITY用于中度至重度性结肠炎患者,而这些患者对其他治疗没有反应.
China approves VELSIPITY for moderate to severe ulcerative colitis patients unresponsive to other treatments.
中国的NMPA批准VELSIPITY® (胺甲类片) 用于中度至重度活跃性性结肠炎的成年人,这些成年人对其他治疗没有反应或无法耐受.
China’s NMPA has approved VELSIPITY® (etrasimod arginine tablets) for adults with moderately to severely active ulcerative colitis who haven’t responded to or can’t tolerate other treatments.
根据第三阶段全面治疗试验(美国联合医院在亚洲进行的最大一项研究)和全球ELEVATE UC数据,这项批准表明,一次口服药物的恢复率、肌肉愈合率和症状控制率都很高,并具有有利的安全特征。
The approval, based on the Phase 3 ENLIGHT UC trial—the largest UC study in Asia—and global ELEVATE UC data, shows the once-daily oral drug delivers high rates of remission, mucosal healing, and symptom control with a favorable safety profile.
这是中国第一个为此批准的有选择性的S1P受体调节器, 提供方便的长期治疗选择, 面对不断上升的UC病例和较年轻的病人,
It’s the first selective S1P receptor modulator approved in China for this indication, offering a convenient long-term treatment option amid rising UC cases and a younger patient population.
专家们说,它解决了未满足的关键需求,支持了更好的疾病管理。
Experts say it addresses key unmet needs and supports better disease management.