Core Insights - The approval of Zilucoplan (brand name Zhuobeike) by the National Medical Products Administration marks a significant advancement in the treatment of generalized myasthenia gravis (gMG) in adults, being the first and only subcutaneous self-administered C5 complement inhibitor with dual inhibition mechanisms [1][3] Industry Overview - Generalized myasthenia gravis is a rare, chronic autoimmune disease affecting approximately 1.2 million patients globally, with around 220,000 cases in China. Symptoms include diplopia, ptosis, dysphagia, and life-threatening respiratory muscle weakness [2] - The disease is characterized by fluctuating symptoms and challenges in long-term management due to limitations in existing treatments, which often have significant side effects and unstable efficacy [2] Product Impact - Zilucoplan offers a convenient administration method, allowing patients to self-inject in just 5-8 seconds, thus reducing the burden of hospital visits and enhancing patient independence in disease management [3] - Clinical studies indicate that Zilucoplan can rapidly improve symptoms within a week and maintain stable efficacy and quality of life over long-term treatment [3]

此次获批使优时比在中国同时提供泽卢克布仑钠和罗泽利昔珠单抗两款创新药物，成为全球唯一可同时 覆盖两种靶向治疗方案的生物制药公司，为全身型重症肌无力患者带来更丰富、针对不同医疗需求的疾 病管理选择。 泽卢克布仑钠是全球首个且唯一经皮下注射、可自行给药并拥有双重抑制作用的新一代C5补体抑制 剂，用于治疗抗AChR抗体阳性的全身型重症肌无力患者。作为一款具备双重抑制作用机制的创新药 物，它能够有效阻断补体介导的神经肌肉接头损伤。患者在家中仅需5–8秒即可完成皮下注射。 经济观察网10月11日，全球生物制药公司优时比(UCB)宣布，中国国家药品监督管理局(NMPA)已批准 泽卢克布仑钠(商品名：卓倍可)上市许可，与常规治疗药物联合用于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患者。 ...

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]