礼来安妥来利、安妥来在华获批 用于治疗成人中重度活动性克罗恩病及溃疡性结肠炎

Core Insights - Eli Lilly's drugs, Anjoulai and Anjoulai Li (generic name: Mirikizumab), have been approved by the National Medical Products Administration for the treatment of moderate to severe active Crohn's Disease (CD) and Ulcerative Colitis (UC) in adults [1][3] Group 1: Product Approval and Significance - The approval of Anjoulai and Anjoulai Li marks a significant step for Eli Lilly in the inflammatory bowel disease (IBD) treatment field in China, being the first innovative drug approved in this area [1][3] - Anjoulai and Anjoulai Li are IgG4 monoclonal antibodies specifically targeting the IL-23 p19 subunit, selectively inhibiting the IL-23 pathway to modulate immune inflammatory responses [1][3] Group 2: Clinical Data and Efficacy - For Crohn's Disease, the VIVID-1 global phase 3 clinical study showed that 45% of patients in the Anjoulai group achieved clinical response at week 12 and clinical remission at week 52, compared to 20% in the placebo group (p<0.0001) [3] - In the same study, 38% of patients in the Anjoulai group achieved endoscopic response at week 52, compared to 9% in the placebo group (p<0.0001) [3] - For Ulcerative Colitis, the LUCENT global phase 3 clinical study indicated that 64% of patients in the Anjoulai group achieved clinical response after 12 weeks, with 24% achieving clinical remission, significantly outperforming the placebo group [4] Group 3: Safety Profile - In the VIVID-1 study, the most common adverse events reported in the Anjoulai group included COVID-19 infection, anemia, joint pain, headache, and upper respiratory infections [5] - The incidence of serious adverse events in the Anjoulai group was 2.8% after 12 weeks, compared to 5.3% in the placebo group, and serious infection rates were 0.7% versus 0.6% [5] - The discontinuation rate due to adverse events was lower in the Anjoulai group compared to the placebo group during both the induction and maintenance phases [5]