再鼎醫藥(09688.HK):衞偉迦®(艾加莫德α注射液)被納入國家醫保藥品目錄
格隆匯12月13日丨再鼎醫藥(09688.HK)宣佈,衞偉迦®(艾加莫德α注射液)("衞偉迦")被納入中國國家醫療保障局公佈的2023年國家基本醫療保險、工傷保險和生育保險藥品目錄("國家醫保藥品目錄")。衞偉迦首次被納入國家醫保藥品目錄,用於治療乙醯膽礆受體(「AChR」)抗體陽性的成人全身型重症肌無力(「gMG」)患者。包括衞偉迦在內,公司目前共有四款產品被納入國家醫保藥品目錄。
重症肌無力是一種慢性自身免疫性疾病,常常會導致人體衰弱和可能危及生命的肌無力。中國大約有17萬gMG患者,其中約 85%患者有確認的AChR 抗體陽性;在gMG中,全身骨骼肌均可受累,進而導致虛弱和早期疲勞。對於患者及其經治醫生來説,複視、面部表情、言語、吞嚥和行走的困難經常出現且較難控制。在更危急的情況下,gMG會影響負責呼吸的肌肉,這可能是致命的。在中國,當前的主要治療方案包括乙醯膽礆酯酶抑制劑、類固醇、免疫抑制劑和IVIg,但這些藥物通常只能恢復部分肌力。
艾加莫德是一款在研的人IgG1抗體的Fc片段,可與新生兒Fc受體("FcRn")結合,旨在減少致病性免疫球蛋白G("IgG")抗體並阻斷IgG循環。FcRn在全身廣泛表達,在保護IgG抗體使其免於降解方面發揮着核心作用。2023年6月,國家藥品監督管理局批准衞偉迦與常規治療藥物聯合,用於治療AChR抗體陽性的成人gMG患者。衞偉迦是中國首個獲批的FcRn拮抗劑。公司於2023年9月將衞偉迦在中國內地商業化上市。公司從argenx處獲得獨家授權,在中國內地、香港、澳門和台灣地區開發和商業化艾加莫德。
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