全球治疗系统性红斑狼疮(SLE)创新双靶生物制剂泰它西普在华率先上市!

2021-04-11 网络 网络

御“狼”有术,中国开启SLE双靶新征程。

御“狼”有术,中国开启SLE双靶新征程

全球首个SLE治疗创新双靶生物制剂泰它西普在华率先上市

2021年4月11日,主题为“新生泰·心生爱”全球首创双靶点治疗系统性红斑(SLE创新一类生物新药泰爱® (通用名:泰它西普)中国上市会在北京隆重办。300余名国系统性红斑(SLE)领域专家、学界领袖、学者、临床精英等众多业内人士聚一堂,共同见证这一60年来首款治疗系统性红斑狼疮的国产双靶点生物新药在中国的首发上市,盛况空前

上市会启动仪式

众多风湿领域大咖的参会更是奠定了系统性红斑狼疮治疗的顶级学术基础,学术专题环节就靶向B细胞治疗系统性红斑狼疮新进展、靶向BLyS/APRIL治疗系统性红斑狼疮的机制及泰它西普治疗SLE临床疗效及安全性数据专题进行了精彩报告,报告专家深度解读了最新试验数据,剖析泰爱®的临床获益与安全性,多个重磅研究结果显示靶向BLyS/APRIL抑制剂疗效更显著,创造性地开启SLE“双靶治疗”的新时代,“中国贡献”+“国智”也受到全球医生的热情关注。

此次新品发布会专家云集,到场部分重要嘉宾名单(排名不分先后)

赵岩教授曾小峰教授、张奉春教授、栗占国教授、张卓莉教授、黄慈波教授、杨程德教授、张烜教授、李梦涛教授、鲍春德教授、黄烽教授、古洁若教授、徐沪济教授、朱平教授、张志毅教授、刘毅教授王荔强教授、张缪佳教授、戴冽教授、杨念生教授、何岚教授、林进教授、叶霜教授、张晓教授、武丽君教授等全国风湿领域专家亲临发布会现场,共“划”布局全球首创的SLE双靶治疗新纪元

国贡献

靶向BLyS/APRIL抑制剂治疗已成为SLE不可或缺的治疗选择

红斑狼疮是一种典型的自身免疫性结缔组织病, SLE是红斑狼疮最常见、也是红斑狼疮各类型中最为严重的一型,多发于15~45岁生育年龄女性。病变累及多器官和系统,其75%的SLE患者会出现肾脏损伤,病情严重时会危及生命。与普通人群相比,SLE患者的全因死亡率增加了2.6倍。同时SLE容易反复复发难以治愈,让女性之色变被很多人称作是不死的癌症

北京协和医院李梦涛教授讲述靶向B细胞治疗SLE新进展

SLE发病机制复杂,治疗存在巨大挑战,药物研发难度大。《2020中国系统性红斑狼疮诊疗指南》显示,我国SLE治疗主要糖皮质激素、免疫抑制剂、抗疟药几大类SLE传统治疗药物长期应用引起的不良反应仍困扰着全球SLE领域和患者。据统计,约60%患者疾病持续活动或反复复发长期大剂量糖皮质激素的使用导致患者器官不可逆损害,甚至诱发感染、骨髓抑制等严重不良反应。降低发、减少药物不良反应,仍然是现在及将来的一个重要研究方向。

随着医学的发展,生物靶向药物也在不断尝试新的探索临床剖析SLE的发病机制发现,有多种因素参与SLE的发病,其中B细胞是SLE发病机制的核心,BLySAPRILB细胞分化成熟的关键因子。泰它西普作为全球首BLyS/APRIL抑制剂,解决了天然TACI易于降解和蛋白质表达困难的问题,“双管齐下”有效阻断BLySAPRIL与受体的结合。Ⅱb期临床研究显示,泰它西普治疗组(80 mg、160mg、240 mg)患者在48周时均具有较高的SRI-4应答率,泰它西普高剂量组的应答率可达79%,显著高于常规治疗组的32%,相比贝利木单抗疗效更加显著泰它西普研究缓解率更高,数据更好,的风湿免疫领域临床发展提供了重要的指导意义

北京协和医学院张奉春教授介绍泰它西普治疗SLE Ⅱb期临床研究

据悉,泰它西普作为“有突出疗效”的创新药已获得国家优先审评资格,并获批SLE适应症。03月12日,泰它西普获得中国国家药品监督管理局(NMPA)的批准上市,正式在中国拉开SLE双靶治疗的序幕。

质的飞跃

新双药物有效降低复发,为SLE患者安全保驾护航

近20年来,SLE的治疗治疗束手无策,到如今泰它西普上市投床使用,的双靶点作用机制切实改善患者预后,提高患者生活质量同时,患者长期使用药物产生的不良反应问题也迎来了新的解决方案。泰它西普是重组人B淋巴细胞刺激因子受体-抗体融合蛋白,是基因序列片段经过优化的融合蛋白结构,生物活性安全性更高从而为患者预防疾病复发、减少药物不良反应的诉求带来希望。

北京大学第一医院张卓莉教授介绍泰它西普安全性

研究数据显,对安慰剂组泰它西普治疗组的BILAG指数恶化比例和PGA评分恶化比例更低。基础及临床研究数据显示,在免疫学指标改善方面,泰它西普能使患者血清免疫球蛋白水平(IgG、IgA、IgM)显著下降,但能够始终维持在正常值下线以上,补体(C3、C4)显著上升,同未观察到非预期的不良反应,显示出较好的安全耐受性。融合蛋白消除半衰期相对单克隆抗体更短(t1/211.8vs19.4天),同时泰它西普下调免疫球蛋白水平成剂量依赖性,临床中如出现安全问题可根据实际情况随时改变剂量或停药,使用更加灵活。有力的声音再次惊艳全

北京协和医院赵岩教授介绍靶向BLyS/APRIL治疗SLE的机制

双靶治疗是SLE诊疗发展里程碑式的进步作为全球首创的靶向BLyS和APRIL的双靶向生物新药,此次泰它西普在中国的首发上市将开启中国双靶点治疗SLE的新时代大门,双靶点的强效机制及创新的融合蛋白结构将为中国风湿学科医生提供SLE的全新治疗利器。泰它西普向世界证明了在重大疾病领域,中国本土原研药物有能力更好地解决中国患者的临床需求,且疗效和安全性俱佳这也体现了中国创新药在风湿免疫领域的贡献,并有希望引领我国乃至全球SLE领域的治疗实践。

来可期

新原研药物步入国殿堂惠及全球

前,泰它西普在中已正式投入临床惠及多中国SLE患者,们走出疾病阴霾信回生活。据悉美国FDA已经授予了泰它西普快速审批通道的资格,正在启动治疗系统性红斑狼疮的临床III期试验,以争取尽早推动该药物在国外多个国家上市,让这一创新的双靶点生物制剂惠及全球SLE患者。

更值得期待的是,泰它西普不仅在系统性红斑狼疮的治疗上实现了重要突破,还有潜力用于其它多种拥有巨大未满足临床需求的自身免疫适应症,其治疗IgA肾炎、干燥综合、视神经脊髓炎、多发性硬化症和重症肌无力等适应症的国内Ⅱ/Ⅲ期临床试验已全面展开,其中多个适应症即将启动全球多中心临床研究,争取更多患者获益。

 参考文献:

[1] Lee YH,et al.Lupus.2016 Jun;25(7):727-34.

[2]  2020中国系统性红斑狼疮诊疗指南[J].中华内科杂志,2020(03):172-185

[3] Yang B,et al.Front Immunol.2020;11 539797.

[4] .Samotij D,Reich A.Biomed Res Int.2019;2019: 8142368.

[5] 张奉春.RC18治疗系统性红斑狼疮的关键临床试验结果.

[6] Wu et al,2000,The Journal of Biological Chemistry, 275: 35478-35485

[7] Hymowitz SG,et al. J Biol Chem,2005,280(8) :72187227.

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createdTime=Mon Apr 12 23:49:57 CST 2021, time=2021-04-12, status=1, ipAttribution=)]
    2021-09-29 13f0c37dm61暂无昵称

    治疗新希望。

    0

  5. 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  7. 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createdTime=Mon Apr 12 23:49:57 CST 2021, time=2021-04-12, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1218232, encodeId=13ff121823291, content=<a href='/topic/show?id=e48b650540c' target=_blank style='color:#2F92EE;'>#泰它西普#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65054, encryptionId=e48b650540c, topicName=泰它西普)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Mon May 09 17:08:12 CST 2022, time=2022-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826026, encodeId=de8c18260267f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, 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createdTime=Mon Apr 12 23:49:57 CST 2021, time=2021-04-12, status=1, ipAttribution=)]
    2021-04-13 zhouqu_8
  9. 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createdTime=Mon Apr 12 23:49:57 CST 2021, time=2021-04-12, status=1, ipAttribution=)]
    2021-04-12 gqylhd

    未来可期

    0

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2021年03月12日,荣昌生物制药(烟台)股份有限公司宣布,其自主研发的泰爱® (通用名:泰它西普)获国家药品监督管理局(NMPA)批准上市。

“中国狼疮之父”,我国风湿病学奠基人之一陈顺乐教授逝世

“中国狼疮之父”,我国风湿病学奠基人之一陈顺乐教授逝世

荣昌生物创新药泰它西普在中国正式获批

荣昌生物创新药泰它西普在中国正式获批

Nat Commun:系统性红斑狼疮相关新基因座的鉴定及祖先群体遗传异质性分析

系统性红斑狼疮(SLE)是一种全球性的具有高度遗传性的自身免疫性疾病,其特征在于自身抗体的产生和多器官损伤。

Nat Commun:系统性红斑狼疮遗传风险突变体的等位基因增强子活性研究

系统性红斑狼疮(SLE)是一种自身免疫性疾病,其可以影响多个器官并最终导致衰弱性炎症反应和死亡。

Nat Commun:I型干扰素促进系统性红斑狼疮患者的发生发展

系统性红斑狼疮(SLE)是一种复发性自身免疫疾病,目前对于该疾病缺乏针对其监测和预测疾病发生的生物学指标。

拓展阅读

J Rheumatol:揭示系统性红斑狼疮中加速动脉粥样硬化的机制:免疫细胞代谢失调与心血管风险

SLE患者中加速动脉粥样硬化背后的复杂机制,特别强调了免疫细胞代谢失调与血管损伤之间的联系。

EULAR关于系统性红斑狼疮管理的建议:2023年更新

2023年EULAR基于新出现的证据和专家意见,对系统性红斑狼疮的治疗建议进行了更新,具体意见如下。

系统性红斑狼疮疾病活动度评分(SLE-DAS)

系统性红斑狼疮疾病活动度评分(SLE-DAS)点击立即使用。

Science:沈南教授发现ZEB2对狼疮致病性B细胞新亚群ABC细胞谱系特化起关键作用

近日,上海交通大学医学院附属仁济医院风湿科沈南教授和中-澳个体化免疫学联合研究中心卡罗拉·维努埃萨(Carola Vinuesa)教授团队在国际顶级期刊《Science》(影

Clin Case Rep:系统性红斑狼疮发病前与FGF23相关的低磷血症佝偻病:一例青少年病例

本文报告一例在系统性红斑狼疮(SLE)发病前发生的与FGF23相关的低磷血症性佝偻病的青少年病例。

Arthritis Res Ther:系统性红斑狼疮患者妊娠期使用他克莫司的安全性及其最佳停药浓度的回顾性分析

他克莫司是系统性红斑狼疮(SLE)的主要治疗方案之一,被认为是一种可以在妊娠的药物。由于对他克莫司在妊娠合并SLE期间的安全性知之甚少,因此设计了本研究。