君實生物(688180.SH)：特瑞普利單抗成為首個獲得FDA突破性療法認定的國產抗PD-1單抗
格隆匯 9 月 10日丨君實生物(688180.SH)公佈，近日，公司產品特瑞普利單抗注射液用於鼻咽癌的治療獲得美國食品藥品監督管理局(“FDA”)突破性療法認定(Breakthrough Therapy Designation)，特瑞普利單抗成為首個獲得FDA突破性療法認定的國產抗PD-1單抗，這是繼2020年5月特瑞普利單抗治療鼻咽癌獲得FDA孤兒藥認定後又一重要註冊進展。
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。該適應症的上市申請是全球首個抗PD-1單抗治療復發/轉移鼻咽癌的新藥上市申請。除此之外，特瑞普利單抗注射液聯合化療作為復發或轉移性鼻咽癌患者一線治療方案的III期臨牀研究JUPITER-02研究(NCT03581786)已完成入組。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。
2020年3月，特瑞普利單抗聯合阿昔替尼治療黏膜黑色素瘤獲得FDA孤兒藥資格認定。2020年5月，特瑞普利單抗治療鼻咽癌獲得FDA孤兒藥資格認定。
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著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包括FDA高層官員在內的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。
此次特瑞普利單抗治療鼻咽癌獲得FDA突破性療法認定能夠顯著地支持並加速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。
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