瑞利珠单抗在华上市,罕见病患者迎来长效补体抑制剂
Bei Ke Cai Jing·2025-09-14 10:35

Core Viewpoint - The long-acting C5 complement inhibitor, Riluzumab injection (Chinese brand name: Weili Rui), has been officially launched in China for the treatment of adult patients with AChR antibody-positive generalized myasthenia gravis (gMG) and AQP4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD) [1][2]. Group 1: Product Overview - Riluzumab acts by targeting and inhibiting the activation of complement C5 in the immune system, providing immediate, complete, and sustained suppression of complement activation [1]. - The drug has been approved this year in China for specific adult gMG and NMOSD patients, demonstrating safety comparable to placebo in clinical studies [1]. Group 2: Clinical Research Findings - In the CHAMPION-MG clinical study, the most common adverse reactions observed in patients treated with Riluzumab were nausea, headache, and diarrhea [1]. - The CHAMPION-NMOSD trial reported common adverse events including COVID-19 infection, headache, back pain, joint pain, and urinary tract infections [1]. - Overall, the safety and tolerability of Riluzumab align with previous clinical studies and real-world practices, with no new safety signals identified [1]. Group 3: Patient Demographics and Treatment Needs - Approximately 113,000 patients with gMG have been diagnosed in China, with 80% being AChR antibody-positive [2]. - NMOSD is a rare central nervous system disease characterized by abnormal immune activation attacking healthy tissues, with about 75% of NMOSD patients producing antibodies that bind to the specific protein AQP4 [2]. - Experts emphasize the need for early and long-term treatment for gMG to mitigate severe impacts on patients, while NMOSD treatment should focus on preventing relapses and controlling symptoms during acute phases [2]. Group 4: Treatment Administration - Riluzumab offers a convenient treatment experience for Chinese patients with a dosing frequency of once every eight weeks, potentially aiding patients in achieving a relapse-free life [2].