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]

Core Viewpoint - UCB has received approval from China's National Medical Products Administration (NMPA) for the marketing authorization of Zilucoplan (brand name: Zhuobeike), a new treatment for adult patients with generalized myasthenia gravis who are positive for anti-acetylcholine receptor (AChR) antibodies [1] Group 1 - Zilucoplan is the first and only subcutaneously administered C5 complement inhibitor that can be self-administered, featuring a dual inhibition mechanism [1] - The drug effectively blocks complement-mediated damage at the neuromuscular junction, providing a new treatment option for patients [1] - Patients can complete the subcutaneous injection at home in just 5-8 seconds, enhancing convenience and accessibility [1] Group 2 - With this approval, UCB now offers both Zilucoplan and Rozanolixizumab in China, making it the only biopharmaceutical company globally to provide two targeted treatment options for generalized myasthenia gravis [1] - This development enriches disease management choices for patients with generalized myasthenia gravis, addressing different medical needs [1]

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]