君實生物(688180.SH):特瑞普利單抗注射液擬納入優先審評程序
格隆匯 7 月 20日丨君實生物(688180.SH)公佈,公司產品於特瑞普利單抗注射液近日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,公示期7日。
藥品名稱:特瑞普利單抗注射液;劑型:注射劑;申報階段:生產;申請人:上海君實生物醫藥科技股份有限公司。

特瑞普利單抗注射液作為中國首個批准上市的以PD-1為靶點的國產單抗藥物,獲得國家科技重大專項項目支持。特瑞普利單抗注射液自2016年初開始臨牀研發,至今已在中、美等多國開展了覆蓋十餘個瘤種的30多項臨牀研究。2018年12月,特瑞普利單抗注射液獲得國家藥品監督管理局(“國家藥監局”)有條件批准上市,用於治療既往標準治療失敗後的局部進展或轉移性黑色素瘤。2020年4月,特瑞普利單抗注射液用於治療既往接受過二線及以上系統治療失敗的復發╱轉移鼻咽癌的新適應症上市申請獲得國家藥監局受理。2020年5月,特瑞普利單抗注射液用於治療既往接受過系統治療的局部進展或轉移性尿路上皮癌的新適應症上市申請獲得國家藥監局受理。
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