榮昌生物(09995.HK)：用於治療全身型重症肌無力藥物泰它西普獲批在中國上市
格隆匯5月27日丨榮昌生物(09995.HK)宣佈，泰它西普(商品名：泰愛®)正式獲得中國國家藥品監督管理局("NMPA")的批準在中國上市，用於治療抗乙酰膽礆受體(AChR)抗體陽性的成人全身型重症肌無力("gMG")患者。
2025年4月9日於美國神經病學學會(AAN)年會上發佈的III期數據顯示，泰它西普在gMG患者中展現了顯著的臨牀獲益和良好的安全性。數據顯示：治療24周後，泰它西普組98.1%的患者重症肌無力日常活動評分(MG-ADL)改善≥3分，遠高於安慰劑組的12.0%，泰它西普組MG-ADL評分相較於基線降低5.74分，安慰劑組降低0.91分；泰它西普組87.0%的患者定量重症肌無力評分(QMG)改善≥5分，遠高於安慰劑組的16.0%，泰它西普組QMG評分相較於基線降低8.66分，安慰劑組降低2.27分，具有顯著治療差異。安全性方面，泰它西普組總體不良事件(AE)發生率與安慰劑組相當，整體安全性良好。
在已完成全身型重症肌無力III期臨牀研究的藥物中，泰它西普的MG-ADL應答率數據最高。此次泰它西普在中國獲批，將讓更多的國內重症肌無力患者受益，在長期的疾病管理進程中，達成更爲優異的治療目標。目前，公司正在推進泰它西普治療重症肌無力患者的全球多中心III期試驗，旨在驗證泰它西普在更廣泛人羣中的療效與安全性。
重症肌無力(Myasthenia Gravis, MG)是一種由神經肌肉接頭(NMJ)傳遞障礙引發的自身免疫性疾病，以波動性肌肉無力和易疲勞性爲核心特徵，治療週期較長且易復發。約80%-85%重症肌無力患者爲AChR抗體陽性患者，超過85%的患者在發病後24個月內會發展爲全身型重症肌無力(gMG)。據弗若斯特沙利文報告，全球重症肌無力患者約120萬人，其中中國患者約22萬人，存在巨大未滿足臨牀需求。
泰它西普由人跨膜激活劑及鈣調親環素配體相互作用因子(TACI)受體的胞外域以及人免疫球蛋白G(IgG)的可結晶片段(Fc)域構成，可同時靶向B細胞激活因子(又稱BLyS)和增殖誘導配體(APRIL)，直擊致病性抗體產生的源頭——B細胞及漿細胞。
除重病肌無力外，泰它西普用於治療系統性紅斑狼瘡(SLE)和類風溼關節炎(RA)兩大適應症已在中國獲批。
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