5月，中国药企荣昌生物研发的泰它西普（商品名：泰爱）也获得中国国家药品监督管理局的批准，该 药物用于治疗AChR抗体阳性的成人全身型重症肌无力患者。 10月11日，跨国药企优时比（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）的上市许可，该药物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（GMG）患者。 资料显示，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，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， 减少了往返医院的负担。 全身型重症肌无力是一种罕见、慢性且异质性的自身免疫性疾病，国内患者人数约22万，常见致病抗体 主要包括AChR抗体和肌肉特异性受体酪氨酸激酶（MuSK）抗体。其中，AChR抗体最为常见，约80% ～90%的患者可检测到该抗体。 《每日经济新闻》记者注意到，近年来多款全身型重症肌无力药物进入中国。今年3月，优时比的另一 款全身型重症肌无力药物——罗泽利昔珠单抗注射液（商品名：优迪革）在国内获批，该药物同时覆盖 AChR阳性和 ...

Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰它西普) for treating IgA nephropathy (IgAN) has achieved the primary research endpoint in the Phase III clinical trial in China [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment, with a dosage of 240mg administered subcutaneously once a week [1] - The A stage analysis showed that the Tai'aisip group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group at 39 weeks (P<0.0001), demonstrating good tolerability and safety [1] Group 2 - IgAN is a common primary glomerular disease, with diverse clinical manifestations, and is a major cause of chronic kidney disease and end-stage renal disease in China, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The academic community believes that the excessive secretion of galactose-deficient IgA1 (Gd-IgA1) is a core factor in the pathogenesis of IgAN [2] - The drug Tai'aisip is a recombinant BLyS/APRIL dual-target fusion protein that inhibits the binding of BLyS and APRIL to B cell surface receptors, effectively reducing pathological immune responses [2]