君实生物(01877.HK)特瑞普利单抗获FDA孤儿药资格认定
君实生物(01877.HK)公布,特瑞普利单抗用於治疗软组织肉瘤已於近日获得美国食品药品监督管理局(FDA)颁发孤儿药资格认定,是特瑞普利单抗获得的第三个孤儿药资格认定。此前,特瑞普利单抗治疗黏膜黑色素瘤及鼻咽癌已分别获得FDA孤儿药资格认定。
本次获得FDA颁发的孤儿药资格认定,有助於特瑞普利单抗在美国的後续研发、注册及商业化等方面享受一定的政策支持,包括临床试验费用的税收抵免;免除新药申请费;享有七年的市场独占权且不受专利的影响。
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