君實生物(01877.HK)：特瑞普利單抗聯合化療一線治療鼻咽癌新適應症上市申請獲受理
格隆匯 2 月 19日丨君實生物(01877.HK)發佈公吿，公司收到國家藥品監督管理局核准簽發的《受理通知書》，特瑞普利單抗(商品名：拓益®，產品代號：JS001)聯合化療用於晚期一線未接受過系統性治療的復發轉移性鼻咽癌的新適應症上市申請獲得受理。
本次新適應症上市申請基於JUPITER-02研究(NCT03581786)，該研究是一項隨機、雙盲、安慰劑對照、國際多中心的III期臨牀研究，由中山大學附屬腫瘤醫院徐瑞華教授擔任主要研究者。研究結果表明，特瑞普利單抗聯合吉西他濱╱順鉑一線治療復發或轉移性鼻咽癌患者，較吉西他濱╱順鉑的標準一線治療，可顯著延長患者的無進展生存期。截至本公吿日，該研究是全球範圍內規模最大的免疫檢查點抑制劑聯合化療一線治療復發或轉移性鼻咽癌的III期臨牀研究。
特瑞普利單抗是中國首個批准上市的以PD-1為靶點的國產單抗藥物，且至今已在中、美等多國開展了覆蓋超過15個適應症的30多項臨牀研究。2018年12月17日，特瑞普利單抗獲得國家藥監局有條件批准上市，用於既往接受全身系統治療失敗的不可切除或轉移性黑色素瘤的治療，並獲得2019年和2020年《中國臨牀腫瘤學會(CSCO)黑色素瘤診療指南》推薦。特瑞普利單抗用於三線治療復發 ╱ 轉移性鼻咽癌，以及特瑞普利單抗用於二線治療轉移性尿路上皮癌的新適應症上市申請分別於2020年4月和2020年5月獲得國家藥監局受理。2020年7月，上述兩項新適應症上市申請已被國家藥監局納入優先審評程序。2020年9月，特瑞普利單抗用於治療復發 ╱ 轉移性鼻咽癌獲得美國食品藥品監督管理局(“FDA”)突破性療法認定。2020年12月，特瑞普利單抗注射液成功通過國家醫保談判，被納入新版醫保目錄。目前，特瑞普利單抗已在黏膜黑色素瘤、鼻咽癌、軟組織肉瘤領域獲得 FDA授予1項突破性療法認定、1項快速通道認定和3項孤兒藥資格認定。
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