港股异动 | 君实生物(1877.HK)涨超5% 公司产品获得FDA突破性疗法认定
格隆汇9月11日丨君实生物(1877.HK)高开高走,现报47.95港元,涨5.38%,暂成交385万港元,最新总市值417亿港元;君实生物(688180.SH)亦涨近3%。君实生物昨日晚间发公告称,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,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。公告称,本次获得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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