国家支持试点落地,上海创新药“八星报喜”

动脉网
Oct 30, 2025

上海又一款国产创新药获批上市,即乐普生物的注射用维贝柯妥塔单抗,为复发/转移性鼻咽癌患者提供新治疗选择,这是上海今年第8款获批的国产1类创新药。同时,这也是上海今年第2款落地的境内生物制品分段生产试点项目。生物制品分段生产通过划分生产工序,实现灵活配置生产资源,此前中国因质量风险等因素未放开,近年随着药审改革和产业高质量发展,开放分段生产需求日益强烈,被列入“上海方案”。今年5月,上海首款分段生产...

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