全球且**!GSK生物制剂*倍力腾(化学名:贝利尤单抗) 二度参展进博会,为系统性红斑狼疮儿童患者带来希望

2020-11-07 医谷网 医谷网

在第二届进博会上,倍力腾(化学名:贝利尤单抗)以全球首个获批用于治疗成人系统性红斑狼疮(SLE)的生物制剂身份首次亮相,备受瞩目。在刚刚开幕的第三届进博会上,贝利尤单抗有了另一个身份—&m

在第二届进博会上,倍力腾(化学名:贝利尤单抗)以全球首个获批用于治疗成人系统性红斑狼疮(SLE)的生物制剂身份首次亮相,备受瞩目。在刚刚开幕的第三届进博会上,贝利尤单抗有了另一个身份——全球首个且唯一用于治疗儿童系统性红斑狼疮的生物制剂,为饱受疾病困扰的患儿和家庭带来新的治疗选择。

贝利尤单抗已在美国、欧洲及日本等地区获批用于5岁以上儿童系统性红斑狼疮的治疗,成为全球唯一获批用于儿童系统性红斑狼疮的生物制剂。在中国,贝利尤单抗于2019年7月获批与常规治疗联合,用于在常规治疗基础上仍具有高疾病活动的活动性、自身抗体阳性的SLE成年患者。过去一年来,GSK致力于将其在中国的适应症扩展至儿童SLE患者,目前儿科适应症已被列入国家优先审评审批名单,并有望在不久的将来获得批准,以惠及更多中国儿童系统性红斑狼疮患者。

复旦大学附属儿科医院党委书记、肾脏科和风湿科学科带头人徐虹教授指出:“儿童系统性红斑狼疮可对儿童生长、发育、学习以及心理产生很多不利的影响,由于儿童患者病情通常较重,如果病情没有得到良好控制,器官受累进展会很快,严重影响患儿寿命。目前儿童系统性红斑狼疮的治疗方式主要包括激素和免疫抑制剂等,由于儿童处于生长发育的关键时期,激素及免疫抑制剂的长期应用可对其骨骼发育、身体形象及生长潜力等产生不利影响。因此临床上亟待出现疗效确切、安全性高、副作用小并且可带来患儿良好预后的新药物出现。未来贝利尤单抗适应症的扩大,不仅将帮助医生打破现有儿童SLE治疗的困境,更将助力患儿减少复发风险,实现长期、有效的疾病控制,守护他们更好地成长。”

目前,我国约有6万名儿童SLE患者,与成人SLE相比,儿童SLE标准化死亡率是成人SLE的近6倍 ,具有起病更急、病情更重、病程更迁徙、肾脏及神经系统受累更严重的特点 。儿童肾脏受累比成人多见且严重,发生率40%-90%,90%在发病第一年内出现 。因此,狼疮患儿对激素的依赖度和使用剂量都更高,由于儿童处于生长发育的关键时期,激素及免疫抑制剂的长期应用可对其骨骼发育、身体形象及生长潜力等产生不利影响,如身材矮小、骨质疏松、多方面影响患儿免疫系统等 。

GSK副总裁、中国处方药和疫苗总经理齐欣表示:“第三届进博会在疫情之下如期召开,GSK如约而至。GSK携数十款重磅创新产品和医疗解决方案亮相第三届进博会,包括‘全球首个且唯一’的儿童系统性红斑狼疮生物制剂贝利尤单抗,这也是我们‘立足中国,携手中国,服务中国’的承诺。我们期望能够帮助狼疮患儿更好的应对疾病的挑战,守护他们更好地成长,让他们不缺席人生的每一个重要时刻。未来,我们将继续引进更多创新药物,解决中国患者的未尽之需。”

*注:贝利尤单抗系统性红斑狼疮儿科适应症尚未在中国获批

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    2020-11-08 zhouqu_8
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