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三生國健(688336.SH):重組抗IL-1β人源化單克隆抗體注射液獲批開展急性痛風性關節炎臨牀試驗
格隆匯 03-11 17:11

格隆匯3月11日丨三生國健(688336.SH)公佈,近日,公司重組抗IL-1β人源化單克隆抗體注射液收到國家藥監局核准簽發的急性痛風性關節炎臨牀試驗《藥物臨牀試驗批准通知書》,SSGJ-613已完成Ia期臨牀試驗所有受試者入組,並將於近期開展急性痛風性關節炎適應症的Ib/II期臨牀試驗。經審查,2021年12月20日受理的重組抗IL-1β人源化單克隆抗體注射液符合藥品註冊的有關要求,同意本品開展急性痛風性關節炎臨牀試驗。

重組抗IL-1β人源化單克隆抗體注射液(SSGJ-613)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SSGJ-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。

目前國外已上市3種抗IL-1抑制劑產品:Anakinra(Sobi公司,IL-1受體拮抗劑,可阻斷IL-1β和IL-1α)、Rilonacept(再生元,可溶性IL-1受體融合蛋白,可中和IL-1β和IL-1α)和Canakinumab(諾華,靶向抑制IL-1β的唯一的全人源化單克隆抗體)。其中,Canakinumab(商品名Ilaris)是與上述兩個產品相比具有半衰期長、靶向IL-1β、特異性強等優勢。2021年諾華的Canakinumab銷售金額達到10.59億美金。以上三種抑制劑均未在國內上市。

目前國內尚無自主研發的針對IL-1β的單克隆抗體上市,考慮到我國急性痛風性關節炎人羣基數大,臨牀上存在巨大的未被滿足的治療需求。因此,新型的、自主研發的、針對IL-1β的單克隆抗體,可以為急性痛風性關節炎患者提供更多的治療選擇。

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