君實生物(688180.SH)：向FDA滾動提交特瑞普利單抗治療鼻咽癌的生物製品許可申請
格隆匯 3 月 3日丨君實生物(688180.SH)公佈，近日，公司子公司TopAlliance Biosciences, Inc.向美國食品藥品監督管理局(“FDA”)滾動提交了特瑞普利單抗(項目代號“TAB001/JS001”)用於治療復發或轉移性鼻咽癌的生物製品許可申請(BiologicsLicense Application，“BLA”)。由於藥品的研發週期長、審批環節多，容易受到一些不確定性因素的影響，敬請廣大投資者謹慎決策，注意防範投資風險。
2020年9月，特瑞普利單抗用於治療復發或轉移性鼻咽癌獲得FDA突破性療法認定。由於獲得該突破性療法認定，特瑞普利單抗治療鼻咽癌的BLA可向FDA滾動提交併獲得滾動審評(Rolling Review)。滾動審評是指藥企在申請新藥上市許可時，可以將申報文件分批次提交FDA進行審評，而無需等待申報文件全部完成後才向FDA提交申請，此舉可縮短新藥的審評週期。特瑞普利單抗成為首個向FDA提交BLA的國產抗PD-1單抗。
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品監督管理局(“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。2021年2月，特瑞普利單抗治療既往接受過二線及以上系統治療失敗的復發/轉移性鼻咽癌患者的新適應症上市申請獲得國家藥監局有條件批准。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已於2020年5月獲得國家藥監局受理，並於2020年7月被國家藥監局納入優先審評程序。2020年12月，特瑞普利單抗注射液成功通過國家醫保談判，被納入新版國家醫保目錄。2021年2月，特瑞普利單抗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國家藥監局受理。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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