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].

Core Points - The National Medical Products Administration has approved Weili Rui® for the treatment of adult neuromyelitis optica spectrum disorder (NMOSD) patients who are positive for aquaporin-4 (AQP4) antibodies, based on positive results from the CHAMPION-NMOSD Phase III clinical trial [1] - The trial demonstrated that the treatment group receiving Riluzumab did not experience any relapses during a median treatment duration of 73 weeks, and the results were consistent over a longer follow-up period of 170.3 weeks [1] - NMOSD is a rare, highly disabling autoimmune disease characterized by unpredictable relapses that can lead to severe neurological damage and permanent disability [1] Group 1 - The CHAMPION-NMOSD Phase III clinical trial used the placebo group from the PREVENT pivotal trial as an external control [1] - Riluzumab achieved the primary endpoint of time to first relapse as determined by an independent adjudication committee [1] - Most patients in the Riluzumab treatment group maintained stable or improved disability assessment scores during the follow-up period [1] Group 2 - Professor Quan Chao from Huashan Hospital emphasized the importance of preventing relapses during remission and quickly controlling symptoms during acute phases to minimize disability accumulation [2] - Riluzumab is a long-acting complement inhibitor that can precisely target complement pathways, providing sustained benefits for patients [2] - AstraZeneca's global senior vice president, Dr. He Jing, noted that this is the second indication approved for Riluzumab in China within six months, highlighting the drug's innovative value [2]