百济神州(06160.HK)：靶向肿瘤免疫疗法迪妥昔单抗中国上市申请获受理
格隆汇 11 月 10日丨百济神州(06160.HK)发布公告，EUSA Pharma与百济神州于2020年11月9日共同宣布中国国家药品监督管理局(NMPA)已受理QARZIBA®▼(迪妥昔单抗)的上市许可申请(BLA)并纳入优先审评。迪妥昔单抗是一款靶向肿瘤免疫疗法，已获欧洲药品管理局(EMA)批准用于治疗一岁以上先前接受过诱导化疗并达到部分缓解的高危神经母细胞瘤患者，随后进行清髓性治疗和干细胞移植，或者复发或难治性神经母细胞瘤的患者，无论是否有残留病灶。高危神经母细胞瘤是一种具有侵袭性的赘生物，也是儿童中最常见起源于脑外的实体瘤。迪妥昔单抗位列NMPA首批临床急需境外新药名单。
百济神州中国区总经理兼公司总裁吴晓滨博士表示：“迪妥昔单抗是一款重要的生物制剂，目前在欧洲已获批用于治疗高危神经母细胞瘤。我们期待迪妥昔单抗能尽快为中国儿童高危神经母细胞瘤患者带来一项新的治疗选项。公司与EUSA的合作进展也体现了我们为有需求人群带来高质量疗法的共同决心。”
EUSA Pharma首席执行官Lee Morley评论道：“这项里程碑使我们和百济神州更加接近先前做出的承诺－为全球患者带来针对肿瘤和罕见病的创新型疗法。我们期待与百济神州和NMPA协作，将迪妥昔单抗带向中国市场。”
根据披露，EUSA Pharma成立于2015年3月，是一家专注于癌症和罕见病的世界一流生物制药公司。公司在美国和欧洲有大型的商业化运营，在全球其他几个市场也有一定的规模。EUSA Pharma的管理团队经验丰富，成功建立了多家制药企业。公司的主要投资方EW Healthcare Partners提供了雄厚的资本。
QARZIBA®▼是一款单克隆抗体，可与神经母细胞瘤细胞上过度表达的一个GD2特定靶点结合。迪妥昔单抗于2017年获得欧盟委员会批准，用于治疗≥12月龄的高危神经母细胞瘤患者，这些患者既往接受过诱导化疗且至少获得部分缓解，并且随后进行过清髓性治疗和干细胞移植治疗；也适用于治疗伴或不伴有残留病灶的复发性或难治性神经母细胞瘤。在治疗复发性神经母细胞瘤之前，应采取适当措施使活动性进展性疾病保持稳定。针对具有复发╱难治性疾病病史和一线治疗后尚未达到完全缓解的患者，应使用迪妥昔单抗联合白介素2(IL-2)治疗。
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