康諾亞－Ｂ(02162.HK)治療慢性鼻竇炎伴鼻息肉新藥臨床試驗數據結果積極

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康諾亞－Ｂ(02162.HK)治療慢性鼻竇炎伴鼻息肉新藥臨床試驗數據結果積極

阿思達克 12-27 09:00

康諾亞－Ｂ(02162.HK)公布，其1類新藥CM310重組人源化單克隆抗體(司普奇拜單抗)注射液治療慢性鼻竇炎伴鼻息肉的III期臨床研究(CM310-102208，登記號：CTR20221480)已完成雙盲治療期數據揭盲及初步統計分析，臨床數據達到主要終點。研究結果顯示III期臨床試驗數據結果積極，共同主要終點均完全達標，CM310組皆優於安慰劑組，具備高度顯著的統計學差異(P值均<0.0001)，且安全性良好。公司計劃將於2024年內向國家藥監局(NMPA)藥品評審中心(CDE)遞交CM310治療慢性鼻竇炎伴鼻息肉的上市許可申請。

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康諾亞－Ｂ(02162.HK)治療慢性鼻竇炎伴鼻息肉新藥臨床試驗數據結果積極

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