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]

新京报讯(记者王卡拉)4月22日，国家药品监督管理局发布的药品批准文件送达信息显示，长效C5补体 抑制剂瑞利珠单抗注射液(中文商品名：伟立瑞)获批上市，与常规治疗药物联用治疗抗乙酰胆碱受体 (AChR)抗体阳性的成人全身型重症肌无力(gMG)患者。 此次批准是基于CHAMPION-MGⅢ期研究的积极结果。研究显示，瑞利珠单抗在主要疗效终点即第26 周重症肌无力日常生活活动(MG-ADL)评分较基线改善方面优于安慰剂。MG-ADL是一个患者自评量 表，用于评估患者进行日常活动能力。此外，经开放标签扩展期研究的长期随访，瑞利珠单抗的临床获 益持续至60周。该研究还观察到，与安慰剂相比，经瑞利珠单抗治疗的每百名患者每年的疾病加重发生 率减少了71.1%。 全身型重症肌无力是一种罕见的、有致残性的慢性自身免疫性神经肌肉疾病，可导致肌肉功能丧失和严 重衰弱。中国已确诊的gMG患者约有11.3万人。北京天坛医院神经免疫科主任施福东教授表示，全身型 重症肌无力严重影响患者，需要尽早启动并长期维持治疗。CHAMPION-MG研究的患者自评报告和医 生提供的报告均显示，瑞利珠单抗展现出快速且持续的改善。每八周一次的给药方式有可 ...