長春高新(000661.SZ):伏欣奇拜單抗注射液上市申請獲得受理
格隆匯1月24日丨長春高新(000661.SZ)公佈,近日,長春高新技術產業(集團)股份有限公司控股子公司長春金賽藥業有限責任公司(簡稱“金賽藥業”)收到國家藥品監督管理局核准簽發的《受理通知書》。
伏欣奇拜單抗是金賽藥業研發的一款抗白介素1β(IL-1β)單抗,通過阻斷IL-1β與IL-1受體I(IL-1RI)和IL-1受體II(IL-1RII)結合起到調節炎症的作用,屬於治療用生物製品1類,擬用於成年痛風性關節炎急性發作患者。
注射用伏欣奇拜單抗(曾用名注射用金納單抗)是金賽藥業研發的一款IL1β單抗凍乾製劑,已經針對GA適應症開展了一系列研究並遞交了新藥上市申請(NDA)。為方便臨牀使用,免去注射前需要復溶與配置的步驟,在注射用伏欣奇拜單抗的基礎上,金賽藥業研製了伏欣奇拜單抗注射液(曾用名金納單抗注射液)。近期完成的一項伏欣奇拜單抗在中國健康成年男性受試者中的隨機、雙盲、單次給藥的生物等效性臨牀試驗結果顯示,伏欣奇拜單抗注射液和注射用伏欣奇拜單抗具有生物等效性且安全性良好。本品的申報上市將提高伏欣奇拜單抗的使用便捷性,更好的滿足臨牀需求。
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