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恆瑞醫藥(600276.SH):SHR-1314注射液獲批臨牀試驗
格隆匯 04-20 18:16

格隆匯 4 月 20日丨恆瑞醫藥(600276.SH)公佈,公司子公司蘇州盛迪亞生物醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發關於SHR-1314注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,202122日受理的SHR-1314注射液符合藥品註冊的有關要求,同意本品進行成人狼瘡腎炎適應症臨牀試驗。

SHR-1314注射液是公司自主研發的一種靶向人IL-17A的重組人源化單克隆抗體,擬用於治療與IL-17通路相關的自身免疫疾病。目前全球已2IL-17A抗體獲批上市。諾華公司的secukinumab (商品名Cosentyx)2015以來美國、歐洲和日本等多個國家和地區獲批上市禮來公司的ixekizumab (商品Taltz)2016以來在美國、歐洲和日本等多個國家和地區獲批上市。Secukinumabixekizumab分別於20194月和9月作為第一批臨牀急需境外新藥在中國獲批上市。經查詢EvaluatePharma數據庫,2020secukinumab銷售額為39.95億美元,ixekizumab17.89億美元。

截至目前,SHR-1314相關研發項目累計已投入研發費用約21125萬元

根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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