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百濟神州(06160.HK):SYLVANT® (注射用司妥昔單抗)在中國上市申請獲受理
格隆匯 01-26 08:13

格隆匯 1 月 26日丨百濟神州(06160.HK)發佈公吿,百濟神州於美國東部時間2021年1月25日與EUSA Pharma共同宣佈中國國家藥品監督管理局(NMPA)已受理薩温珂®(注射用司妥昔單抗)的上市許可申請(BLA)並納入優先審評。注射用司妥昔單抗是一款單克隆抗體,已獲歐洲藥品管理局(EMA)及美國食品藥品監督管理局(FDA)批准用於治療人類免疫缺陷病毒(HIV)陰性和人類皰疹病毒8(HHV-8)陰性的成人特發性多中心卡斯特曼病(多中心Castleman病)成年患者,又稱iMCD。iMCD是一種罕見、危及生命的衰竭性淋巴組織增生的疾病。注射用司妥昔單抗是NMPA首批臨牀急需境外新藥名單中的藥品。

百濟神州中國區總經理兼公司總裁吳曉濱博士表示:“司妥昔單抗是一款用於治療特發性多中心型Castleman病的重要療法,已在40多個國家獲批。對中國患者而言,國家藥監局受理其上市許可申請是個好消息。百濟神州與EUSA Pharma的合作基礎是共同承諾為中國和全球患者帶來有影響力療法,很欣慰雙方的合作能夠不斷取得新的進展。”

EUSA Pharma首席執行官Lee Morley評論道:“司妥昔單抗在中國的上市申請獲得監管部門受理,是我們為全球有需求患者帶來有效治療方案的又一重要里程碑。我們會繼續和百濟神州緊密合作,儘早將司妥昔單抗帶給中國的iMCD患者。”

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