康諾亞-B(02162.HK):司普奇拜單抗注射液治療慢性鼻竇炎伴鼻息肉的藥品上市許可申請獲國家藥監局受理
格隆匯6月7日丨康諾亞-B(02162.HK)發佈公吿,司普奇拜單抗注射液治療慢性鼻竇炎伴鼻息肉的藥品上市許可申請,已於近期獲國家藥品監督管理局(“國家藥監局”)受理,並納入優先審評審批程序。
此次申報是基於一項多中心、隨機、雙盲、安慰劑對照的III期臨牀研究,主要用於確證司普奇拜單抗注射液在治療慢性鼻竇炎伴鼻息肉患者中的有效性及安全性。研究結果顯示本項III期臨牀試驗數據結果積極,共同主要終點均達到,並具備高度顯着的統計學差異,且安全性良好。
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