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君實生物(01877.HK)鼻咽癌單抗藥物完成向FDA提交許可申請
阿思達克 09-02 05:13
君實生物(01877.HK)公布,子公司TopAlliance Biosciences, Inc.已完成向FDA(美國食品藥品監督管理局)滾動提交關於特瑞普利單抗聯合吉西他濱/順鉑作為晚期復發或轉移性鼻咽癌患者的一線治療和單藥用於復發或轉移性鼻咽癌含鉑治療後的二線及以上治療的生物製品許可申請。 特瑞普利單抗是中國首個批准上市的以PD-1為靶點的國產單抗藥物,至今已在中、美等多國開展了覆蓋超過15個適應症的30多項臨床研究。
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