首个国产干细胞注射液附条件批准上市,科伦博泰抗PD-L1单抗新药获批上市,礼来替尔泊肽在华上市,赛诺菲BTK抑制剂在中国申报上市

医药经济报
02 Jan

铂生卓越生物科技干细胞疗法艾米迈托赛获批上市近日,NMPA 官网显示,铂生卓越生物科技(北京)有限公司的干细胞疗法“艾米迈托赛”获批上市,用于治疗 14 岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病。这是国内首款获批上市的干细胞疗法。据悉,艾米迈托赛是一款间充质干细胞疗法(MSC)。该药早在 2013 年 3 月就在国内递交了 IND 申请,但直至 2020 年 6 月才首次公示临床试验...

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