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信達生物(01801.HK):蘇立信®(阿達木單抗生物類似藥)獲批上市
格隆匯 09-03 17:30

格隆匯 9 月 3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®(阿達木單抗生物類似藥,英文商標:SULINNO®)正式獲得國家藥品監督管理局( "NMPA")在中國上市的批准,用於治療類風濕關節炎、強直性脊柱炎和銀屑病。這是繼達伯舒®(信迪利單抗注射液)和達攸同®(貝伐珠單抗生物類似藥)之後,公司第三個獲得NMPA上市批准的單克隆抗體藥物。蘇立信®的上市獲批標誌着公司的上市產品拓展到了非腫瘤領域。

中國有近二千萬類風濕關節炎、強直性脊柱炎或銀屑病患者。該類疾病不僅造成患者身體機能、生活質素和社會參與度下降,也給患者家庭和社會帶來了巨大的經濟負擔。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。阿達木單抗注射液在北美和歐洲廣泛使用,多個診療指南一致推薦使用該藥治療上述疾病,其顯著的療效已得到普遍認可。當前,阿達木單抗注射液的治療費用仍然超出了很多中國普通患者的承受能力,導致中國內的阿達木單抗使用率較低。公司自主研發的蘇立信®是阿達木單抗生物類似藥,與阿達木單抗具有相似的臨牀療效和安全性,其臨牀研究結果於2019年被刊登在國際知名期刊《柳葉刀·風濕病學》創刊號上。蘇立信?的上市將為更多中國患者提供高品質且相對可負擔的阿達木單抗注射液,給更多患者帶來希望與機會。

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