君實生物(01877.HK)：特瑞普利單抗聯合化療一線治療鼻咽癌獲得FDA突破性療法認定
格隆匯8月11日丨君實生物(01877.HK)發佈公吿，近日，公司產品特瑞普利單抗（商品名：拓益，產品代號：JS001）聯合吉西他濱/順鉑作為晚期復發或轉移性鼻咽癌患者的一線治療獲得美國食品藥品監督管理局（以下簡稱“FDA”）突破性療法認定（Breakthrough Therapy Designation）。2020年9月，特瑞普利單抗單藥用於復發或轉移性鼻咽癌含鉑治療後的二線及以上治療已獲得FDA突破性療法認定，成為首個獲得FDA突破性療法認定的國產抗PD-1單抗。2021年3月，基於此認定，公司向FDA滾動提交了特瑞普利單抗二線及以上治療復發或轉移性鼻咽癌的生物製品許可申請（Biologics License Application，以下簡稱“BLA”），並獲得滾動審評（Rolling review），目前已完成申報材料遞交。
此次獲得的第二項突破性療法認定拓寬了FDA對特瑞普利單抗治療鼻咽癌適應症的認定範圍，將加快相關適應症在FDA的審批速度，公司預計將在2021年第三季度內完成特瑞普利單抗聯合化療一線治療復發或轉移性鼻咽癌適應症的BLA提交。
突破性療法源於《美國食品和藥物管理局安全及創新法案》（FDASIA）的規定，適用於治療嚴重或危及生命的疾病且初步臨牀證據顯示出顯着優於現有療法的藥品，旨在加速該藥品的開發和審評程序，是繼快速通道、加速批准、優先審評之後，FDA又一重要的新藥評審通道。根據規定，獲得突破性藥物療法認定的藥物開發過程將獲得FDA高層官員更加密切的指導及多種形式的支持，保障在最短時間內為患者提供新的治療選擇。
此次獲得的第二項突破性療法認定拓寬了FDA對特瑞普利單抗治療鼻咽癌適應症的認定範圍，將加快相關適應症在FDA的審批速度，並進一步推進特瑞普利單抗在美國的商業化開發計劃。公司將與FDA密切協作，保障藥品開發計劃高效實施。公司預計將在2021年第三季度內完成特瑞普利單抗聯合化療一線治療復發或轉移性鼻咽癌適應症的BLA提交，惠及更多患者，滿足全球鼻咽癌患者未被滿足的治療需求。
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