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信達生物(01801.HK):蘇立信®兩項新適應症在中國獲批
格隆匯 12-23 12:11

格隆匯12月23日丨信達生物(01801.HK)宣佈,公司自主研發的重組人抗腫瘤壞死因子-α(“TNF-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”)批准兩項新適應症,用於治療:1)兒童斑塊狀銀屑病;及2)對糖皮質激素應答不充分、需要節制使用糖皮質激素、或不適合進行糖皮質激素治療的成年非感染性中間葡萄膜炎、後葡萄膜炎和全葡萄膜炎。

蘇立信®於2020年9月2日首次獲得NMPA上市批准。此前蘇立信®已獲批的適應症包括類風濕關節炎、強直性脊柱炎、銀屑病、多關節型幼年特發性關節炎。

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,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銀屑病和葡萄膜炎患者提供一個高質量、高可及性的治療選擇。

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