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古塞奇尤单抗在华上市,克罗恩病和溃疡性结肠炎迎新疗法
J&JJ&J(US:JNJ) Bei Ke Cai Jing·2025-06-10 04:32

Core Viewpoint - The approval of Janssen's Guselkumab injection (Tenuat) for the treatment of moderate to severe active Crohn's disease and ulcerative colitis in adults marks a significant advancement in addressing the rising incidence of these inflammatory bowel diseases (IBD) in China [1][2]. Group 1: Disease Overview - The incidence of Crohn's disease (CD) and ulcerative colitis (UC) has been steadily increasing in China over the past few decades, with a trend of earlier onset age [1]. - Crohn's disease is a chronic inflammatory condition that can affect the entire digestive tract, with symptoms including abdominal pain, diarrhea, and weight loss, and currently has no cure [1]. - Ulcerative colitis leads to inflammation of the digestive tract and can cause significant damage to the colon's mucosa, with symptoms such as frequent diarrhea and rectal bleeding, primarily affecting younger patients aged 20 to 49 [1]. Group 2: Treatment Efficacy - Tenuat is the first and only fully human monoclonal antibody that selectively neutralizes interleukin-23, providing sustained deep remission in the treatment of Crohn's disease and ulcerative colitis [2]. - Clinical trials have shown that Guselkumab demonstrates superior efficacy compared to Ustekinumab in achieving multiple controlled endoscopic endpoints for Crohn's disease treatment [2]. - Research indicates that within one year, 45%-50% of ulcerative colitis patients achieved clinical remission, and 34%-35% attained endoscopic remission [2].