百濟神州(06160.HK):靶向腫瘤免疫療法迪妥昔單抗中國上市申請獲受理
格隆匯 11 月 10日丨百濟神州(06160.HK)發佈公告,EUSA Pharma與百濟神州於2020年11月9日共同宣佈中國國家藥品監督管理局(NMPA)已受理QARZIBA®▼(迪妥昔單抗)的上市許可申請(BLA)並納入優先審評。迪妥昔單抗是一款靶向腫瘤免疫療法,已獲歐洲藥品管理局(EMA)批准用於治療一歲以上先前接受過誘導化療並達到部分緩解的高危神經母細胞瘤患者,隨後進行清髓性治療和幹細胞移植,或者復發或難治性神經母細胞瘤的患者,無論是否有殘留病灶。高危神經母細胞瘤是一種具有侵襲性的贅生物,也是兒童中最常見起源於腦外的實體瘤。迪妥昔單抗位列NMPA首批臨牀急需境外新藥名單。
百濟神州中國區總經理兼公司總裁吳曉濱博士表示:“迪妥昔單抗是一款重要的生物製劑,目前在歐洲已獲批用於治療高危神經母細胞瘤。我們期待迪妥昔單抗能儘快為中國兒童高危神經母細胞瘤患者帶來一項新的治療選項。公司與EUSA的合作進展也體現了我們為有需求人羣帶來高質量療法的共同決心。”
EUSA Pharma首席執行官Lee Morley評論道:“這項里程碑使我們和百濟神州更加接近先前做出的承諾-為全球患者帶來針對腫瘤和罕見病的創新型療法。我們期待與百濟神州和NMPA協作,將迪妥昔單抗帶向中國市場。”
根據披露,EUSA Pharma成立於2015年3月,是一家專注於癌症和罕見病的世界一流生物製藥公司。公司在美國和歐洲有大型的商業化運營,在全球其他幾個市場也有一定的規模。EUSA Pharma的管理團隊經驗豐富,成功建立了多家制藥企業。公司的主要投資方EW Healthcare Partners提供了雄厚的資本。
QARZIBA®▼是一款單克隆抗體,可與神經母細胞瘤細胞上過度表達的一個GD2特定靶點結合。迪妥昔單抗於2017年獲得歐盟委員會批准,用於治療≥12月齡的高危神經母細胞瘤患者,這些患者既往接受過誘導化療且至少獲得部分緩解,並且隨後進行過清髓性治療和幹細胞移植治療;也適用於治療伴或不伴有殘留病灶的複發性或難治性神經母細胞瘤。在治療複發性神經母細胞瘤之前,應採取適當措施使活動性進展性疾病保持穩定。針對具有復發╱難治性疾病病史和一線治療後尚未達到完全緩解的患者,應使用迪妥昔單抗聯合白介素2(IL-2)治療。
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