百济神州(06160.HK):SYLVANT® (注射用司妥昔单抗)在中国上市申请获受理
格隆汇 1 月 26日丨百济神州(06160.HK)发布公告,百济神州于美国东部时间2021年1月25日与EUSA Pharma共同宣布中国国家药品监督管理局(NMPA)已受理萨温珂®(注射用司妥昔单抗)的上市许可申请(BLA)并纳入优先审评。注射用司妥昔单抗是一款单克隆抗体,已获欧洲药品管理局(EMA)及美国食品药品监督管理局(FDA)批准用于治疗人类免疫缺陷病毒(HIV)阴性和人类疱疹病毒8(HHV-8)阴性的成人特发性多中心卡斯特曼病(多中心Castleman病)成年患者,又称iMCD。iMCD是一种罕见、危及生命的衰竭性淋巴组织增生的疾病。注射用司妥昔单抗是NMPA首批临床急需境外新药名单中的药品。
百济神州中国区总经理兼公司总裁吴晓滨博士表示:“司妥昔单抗是一款用于治疗特发性多中心型Castleman病的重要疗法,已在40多个国家获批。对中国患者而言,国家药监局受理其上市许可申请是个好消息。百济神州与EUSA Pharma的合作基础是共同承诺为中国和全球患者带来有影响力疗法,很欣慰双方的合作能够不断取得新的进展。”
EUSA Pharma首席执行官Lee Morley评论道:“司妥昔单抗在中国的上市申请获得监管部门受理,是我们为全球有需求患者带来有效治疗方案的又一重要里程碑。我们会继续和百济神州紧密合作,尽早将司妥昔单抗带给中国的iMCD患者。”
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