Core Insights - UCB's drug, Zilucoplan (brand name: Zhuobeike), has received approval from China's National Medical Products Administration (NMPA) for the treatment of adult generalized myasthenia gravis (GMG) patients who are positive for acetylcholine receptor (AChR) antibodies [1] - Zilucoplan is the first and only subcutaneous self-administered C5 complement inhibitor, which can effectively block complement-mediated neuromuscular junction damage, allowing patients to self-administer the injection at home in just 5-8 seconds [1] - The prevalence of generalized myasthenia gravis in China is approximately 220,000 patients, with AChR antibodies detected in 80%-90% of cases [1] Drug Market Overview - Several drugs for generalized myasthenia gravis have entered the Chinese market recently, including UCB's other drug, Rozanolixizumab (brand name: Yudige), which was approved in March and covers both AChR-positive and MuSK-positive patients [1] - AstraZeneca's long-acting C5 complement inhibitor, Riluzole (brand name: WeiliRui), was approved in April for AChR-positive adult GMG patients [2] - Rongchang Biotech's Taitasip (brand name: Tai'ai) was also approved in May for AChR-positive adult GMG patients [2] - The number of subcutaneous injection options remains limited compared to intravenous formulations, with the approval of Efgartigimod (brand name: WeiliJia) in July last year, which requires a longer administration time of 30-90 seconds [2]

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 long-acting C5 complement inhibitor, Riluzole injection (trade name: Weili Rui), has been officially approved in China for the treatment of adult patients with AQP4 antibody-positive Neuromyelitis Optica Spectrum Disorder (NMOSD) [1] - The approval is based on positive results from the CHAMPION-NMOSD Phase III clinical trial, which has been published in the Annals of Neurology [1] - NMOSD is a rare, highly disabling autoimmune disease primarily affecting the central nervous system, particularly the spinal cord and optic nerves [1] - Patients with NMOSD often experience unpredictable relapses, which can lead to new or worsening neurological damage, resulting in severe and recurrent neurological deficits or even permanent disability [1] - Riluzole, as a long-acting complement inhibitor, can precisely target complement pathways, providing sustained benefits with a dosing frequency of once every eight weeks, offering a more convenient treatment experience for patients in China [1] Industry Context - Riluzole has also been approved in the United States, European Union, Japan, and other regions for the treatment of AQP4 antibody-positive adult NMOSD patients, and has received multiple indications in various countries [2]