港股異動 | 君實生物(1877.HK)高開5.13%創歷史新高 單抗藥物獲FDA快速通道資格及臨試批准
格隆匯1月25日丨君實生物(1877.HK)高開5.13%,報82港元創歷史新高,最新H股市值715億港元。君實生物(688180.SH)亦高開逾3%。君實生物公佈,近日,產品特瑞普利單抗一線治療黏膜黑色素瘤獲FDA(美國食品藥品監督管理局)授予快速通道資格。同時,特瑞普利單抗聯合阿昔替尼一線治療黏膜黑色素瘤患者的臨牀試驗申請獲得批准,同意直接開展III期臨牀研究。公吿稱,本次特瑞普利單抗獲得FDA快速通道資格是其獲得FDA孤兒藥認定、突破性療法認定又一里程碑式進展。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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