港股異動 | 君實生物(1877.HK)漲超5% 公司產品獲得FDA突破性療法認定
格隆匯9月11日丨君實生物(1877.HK)高開高走,現報47.95港元,漲5.38%,暫成交385萬港元,最新總市值417億港元;君實生物(688180.SH)亦漲近3%。君實生物昨日晚間發公告稱,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,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。公告稱,本次獲得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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