信達生物(01801.HK)：蘇立信獲國家藥品監督管理局批准新適應症
格隆匯11月23日丨信達生物(01801.HK)發佈公告，公司自主研發的重組人抗腫瘤壞死因子－α單克隆抗體藥物蘇立信®（阿達木單抗注射液，英文商標：SULINNO®）正式獲得國家藥品監督管理局( NMPA)批准，用於治療多關節型幼年特發性關節炎（polyarticular juvenile idiopathic arthritis，pJIA），成為蘇立信®在中國獲批的第4個適應症。此前，蘇立信®於2020年9月2日獲得NMPA上市批准，獲批適應症為類風濕關節炎、強直性脊柱炎、銀屑病。
幼年特發性關節炎（juvenile idiopathic arthritis，JIA）是指16歲或16歲以下不明原因的、病程6周或6周以上的關節炎。關節炎分為少關節炎（＜5個關節）和多關節炎。多關節炎又可分為兩個亞型：類風濕因子（rheumatoid factor，RF）陰性多關節型JIA和RF陽性多關節型JIA。據估計，RF陰性多關節型JIA每年影響1-4/100,000例兒童。較少見的RF陽性多關節型JIA的發生率估計為每年0.3-0.7/100,000例兒童。JIA發生於兒童階段，且伴發症狀較多，若不予治療，則會導致較高的畸型、殘疾、死亡率，嚴重影響兒童的生活質量。早期積極治療可改善結果，並預防潛在的併發症。
蘇立信®為阿達木單抗注射液的生物類似藥，是公司自主研發的重組人抗TNF-α單克隆抗體。原研藥阿達木單抗注射液自上市以來，全球已批准其用於治療包括類風濕關節炎、強直性脊柱炎、銀屑病、銀屑病關節炎、幼年特發性關節炎、克羅恩病（包括兒童克羅恩病）、潰瘍性結腸炎、化膿性汗腺炎、葡萄膜炎等十七種疾病，其顯着的療效和安全性已得到全球認可。其中，該藥在北美和歐洲已被廣泛使用，多個診療指南一致推薦使用阿達木單抗治療該等疾病，包括JIA，其顯著的療效已得到普遍認可。
公司相信，蘇立信®新適應症的成功獲批，將為國內多關節型幼年特發性關節炎患兒提供一個高質量及高可及性的治療選擇。
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