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嘉和生物-B(06998.HK):GB242(英夫利西單抗)新藥上市申請獲國家藥監局批准
格隆匯 03-01 12:10

格隆匯3月1日丨嘉和生物-B(06998.HK)宣佈,旗下GB242英夫利西單抗已獲中國國家藥品監督管理局(“NMPA”)批准,用治療類風濕性關節炎、強直性脊柱炎、銀屑病、成人潰瘍性結腸炎、成人及6歲以上兒童克羅恩病、瘻管性克羅恩病。

GB242的新藥上市申請是基於一項在中國類風濕性關節炎患者中開展的與類克®(英夫利西單抗)比較的三期臨牀試驗。

作為公司第一個商業化藥品,GB242獲NMPA批准為中國患者帶來更多治療選擇。其亦為公司發展歷程中的重要里程碑,及各部門緊密合作和出色執行力的成功例證。董事會謹此感謝所有為GB242成功臨牀開發作出貢獻的患者及研究人員,同時亦感謝監管部門為產品上市而開展的專業及高效的審評工作,旨在解決廣大中國患者迫切及尚未滿足的醫療需求。

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