【提示】国家药监局批准注射用维拉苷酶β上市

上海发布
15 May

市药监局介绍,国家药品监督管理局近日通过优先审评审批程序批准北海康成(上海)生物科技有限公司申报的注射用维拉苷酶β(商品名:戈芮宁)上市,适用于12岁及以上青少年和成人I型和Ⅲ型戈谢病患者的长期酶替代治疗。这是本市今年第4款获批上市的国产1类创新药。详见↓该药获益于上海率先推进的生物制品分段生产试点改革,北海康成(上海)生物科技有限公司作为上市许可持有人,原液委托上海药明生物技术有限公司生产,制剂...

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