中国类风湿关节炎患者的福音!阿达木单抗生物类似物SULINNO在中国获准上市

2020-09-03 Allan MedSci原创

信达生物(Innovent Biologics)今日宣布,SULINNO(重组人抗TNF-α单克隆抗体注射剂,阿达木单抗生物类似物)已获得NMPA的正式批准。

信达生物(Innovent Biologics)今日宣布,SULINNO®(重组人抗TNF-α单克隆抗体注射剂,阿达木单抗生物类似物)已获得中国国家药品监督管理局(NMPA)的正式批准,可用于治疗风湿性关节炎、强直性脊柱炎和牛皮癣。SULINNO®是信达生物的第三种获得NMPA批准的单克隆抗体药物,先前,TYVYT®(信迪利单抗注射液)和BYVASDA®(贝伐单抗注射液)已获得了NMPA的批准。SULINNO®的获批标志着信达生物向非肿瘤领域的扩展。

在中国,有近2000万人患有类风湿关节炎、强直性脊柱炎或牛皮癣。这种疾病不仅导致患者身体机能的下降,患者生活质量和社会参与度也下降,给患者家庭和社会带来了沉重的经济负担。自阿达木单抗上市以来,它已在世界范围内被批准用于治疗十七种疾病,包括类风湿性关节炎、强直性脊柱炎、牛皮癣、牛皮癣关节炎、幼年特发性关节炎、克罗恩病(包括小儿克罗恩病)、溃疡性结肠炎和尿道炎,阿达木单抗的疗效和安全性已为全球所公认。

阿达木单抗注射液在北美和欧洲广泛使用,其显著疗效已得到普遍认可。但是,由于阿达木单抗注射液原研药的价格仍然超出了许多普通患者的承受能力,因此阿达木单抗在中国的使用仍然受到限制。阿达木单抗生物仿制药SULINNO®与阿达木单抗具有相似的临床疗效和安全性,其临床结果发表在2019年的《柳叶刀风湿病学》之上。SULINNO®的上市将为更多中国患者提供高质量且相对负担得起的阿达木单抗注射,为更多患者带来希望。

 

原始出处:

https://www.firstwordpharma.com/node/1754577?tsid=4

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    2021-06-08 ms1000001565165616

    谢谢!

    0

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    2020-09-06 hff2020

    不知道是否可用于幼年特发性关节炎

    0

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    2020-09-05 lmm397
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