信达生物(01801.HK)：苏立信获国家药品监督管理局批准新适应症
格隆汇11月23日丨信达生物(01801.HK)发布公告，公司自主研发的重组人抗肿瘤坏死因子－α单克隆抗体药物苏立信®（阿达木单抗注射液，英文商标：SULINNO®）正式获得国家药品监督管理局( NMPA)批准，用于治疗多关节型幼年特发性关节炎（polyarticular juvenile idiopathic arthritis，pJIA），成为苏立信®在中国获批的第4个适应症。此前，苏立信®于2020年9月2日获得NMPA上市批准，获批适应症为类风湿关节炎、强直性脊柱炎、银屑病。
幼年特发性关节炎（juvenile idiopathic arthritis，JIA）是指16岁或16岁以下不明原因的、病程6周或6周以上的关节炎。关节炎分为少关节炎（＜5个关节）和多关节炎。多关节炎又可分为两个亚型：类风湿因子（rheumatoid factor，RF）阴性多关节型JIA和RF阳性多关节型JIA。据估计，RF阴性多关节型JIA每年影响1-4/100,000例儿童。较少见的RF阳性多关节型JIA的发生率估计为每年0.3-0.7/100,000例儿童。JIA发生于儿童阶段，且伴发症状较多，若不予治疗，则会导致较高的畸型、残疾、死亡率，严重影响儿童的生活质量。早期积极治疗可改善结果，并预防潜在的并发症。
苏立信®为阿达木单抗注射液的生物类似药，是公司自主研发的重组人抗TNF-α单克隆抗体。原研药阿达木单抗注射液自上市以来，全球已批准其用于治疗包括类风湿关节炎、强直性脊柱炎、银屑病、银屑病关节炎、幼年特发性关节炎、克罗恩病（包括儿童克罗恩病）、溃疡性结肠炎、化脓性汗腺炎、葡萄膜炎等十七种疾病，其显着的疗效和安全性已得到全球认可。其中，该药在北美和欧洲已被广泛使用，多个诊疗指南一致推荐使用阿达木单抗治疗该等疾病，包括JIA，其显著的疗效已得到普遍认可。
公司相信，苏立信®新适应症的成功获批，将为国内多关节型幼年特发性关节炎患儿提供一个高质量及高可及性的治疗选择。
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