君實生物(01877.HK)單抗藥物新適應症上市申請獲受理
君實生物(01877.HK)公佈,收到國家藥品監督管理局覈準簽發通知書,特瑞普利單抗(商品名:拓益)聯合含鉑化療一線治療局部晚期或轉移性食管鱗癌的新適應症上市申請獲得受理。
特瑞普利單抗是中國首個批準上市的以PD-1爲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多項臨牀研究。
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