君实生物(688180.SH)：特瑞普利单抗成为首个获得FDA突破性疗法认定的国产抗PD-1单抗
格隆汇 9 月 10日丨君实生物(688180.SH)公布，近日，公司产品特瑞普利单抗注射液用于鼻咽癌的治疗获得美国食品药品监督管理局(“FDA”)突破性疗法认定(Breakthrough Therapy Designation)，特瑞普利单抗成为首个获得FDA突破性疗法认定的国产抗PD-1单抗，这是继2020年5月特瑞普利单抗治疗鼻咽癌获得FDA孤儿药认定后又一重要注册进展。
特瑞普利单抗注射液作为中国首个批准上市的以PD-1为靶点的国产单抗药物，获得国家科技重大专项项目支持。特瑞普利单抗注射液自2016年初开始临床研发，至今已在中、美等多国开展了覆盖十余个瘤种的30多项临床研究。
2018年12月，特瑞普利单抗注射液获得国家药品监督管理局(“国家药监局”)有条件批准上市，用于治疗既往标准治疗失败后的局部进展或转移性黑色素瘤。2020年4月，特瑞普利单抗注射液用于治疗既往接受过二线及以上系统治疗失败的复发╱转移鼻咽癌的新适应症上市申请获得国家药监局受理。该适应症的上市申请是全球首个抗PD-1单抗治疗复发/转移鼻咽癌的新药上市申请。除此之外，特瑞普利单抗注射液联合化疗作为复发或转移性鼻咽癌患者一线治疗方案的III期临床研究JUPITER-02研究(NCT03581786)已完成入组。2020年5月，特瑞普利单抗注射液用于治疗既往接受过系统治疗的局部进展或转移性尿路上皮癌的新适应症上市申请获得国家药监局受理。
2020年3月，特瑞普利单抗联合阿昔替尼治疗黏膜黑色素瘤获得FDA孤儿药资格认定。2020年5月，特瑞普利单抗治疗鼻咽癌获得FDA孤儿药资格认定。
突破性疗法源于《美国食品和药物管理局安全及创新法案》(FDASIA)的规定，适用于治疗严重或危及生命的疾病且初步临床证据显示出显著优于现有疗法的药品，旨在加速该药品的开发和审评程序，是继快速通道、加速批准、优先审评之后，FDA又一重要的新药评审通道。根据规定，获得突破性药物疗法认定的药物开发过程将获得包括FDA高层官员在内的更加密切的指导及多种形式的支持，保障在最短时间内为患者提供新的治疗选择。
此次特瑞普利单抗治疗鼻咽癌获得FDA突破性疗法认定能够显著地支持并加速特瑞普利单抗在美国的商业化开发计划。公司将与FDA密切协作，保障药品开发计划高效实施。
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