信達生物(01801.HK)擬就治療甲狀腺眼病藥物向藥監局遞交新藥上市申請
信達生物(01801.HK)公布,其研發的重組抗胰島素樣生長因子1受體(IGF-1R)抗體注射液(研發代號:IBI311)在中國甲狀腺眼病(TED)受試者中開展的III期註冊臨床研究(RESTORE-1)達成主要終點。公司計劃將向國家藥監局藥品審評中心(CDE)遞交IBI311治療TED的新藥上市申請(NDA)。
公司指出,RESTORE-1(CTR20223393)是一項在TED受試者中評估IBI311有效性和安全性的多中心、隨機、雙盲安慰劑對照的II/III期臨床研究。整個研究期間IBI311整體安全性良好,未發生嚴重不良事件。RESTORE-1研究III期階段的療效趨勢和安全性特徵與II期階段結果高度一致。
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