三生國健(688336.SH):重組抗 IL-1β人源化單克隆抗體注射液臨牀試驗獲批
格隆匯7月8日丨三生國健(688336.SH)公吿,近日,公司重組抗IL-1β人源化單克隆抗體注射液(研發代號:SSGJ-613)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。
重組抗IL-1β人源化單克隆抗體注射液是一個全新的抗IL-1β抗體,該抗體具有全新的可變區序列。實驗結果表明613與目前已上市的同靶點產品Canakinumab具有完全不同的結合表位。
根據國家藥品註冊相關的法律法規要求,藥品在獲得《臨牀試驗通知書》後,尚需開展一系列臨牀試驗,並經國家藥監局批准後方可生產上市,短期內對公司經營業務不會產生較大的影響。
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