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北海康成一款戈谢病新药拟纳入优先审评
新京报讯(记者张兆慧)9月20日,家药监局药品审评中心官网公示,北海康成注射用维拉苷酶β拟纳入优先审评,适用于确诊为戈谢病I型(GD1)和Ⅲ型(GD3)患者的长期酶替代治疗(ERT)。注射用维拉苷酶β是北海康成针对戈谢病开发的酶替代疗法CAN103。北海康成此前曾表示,计划于2024年第四季度提交新药申请(NDA)。大多数戈谢 ...
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