二次闯关!华海生物阿达木单抗重新申报上市,国产企业已达8家

药时空
Oct 16

2025年10月16日,据国家药品监督管理局药品审评中心(CDE)显示,浙江华海生物科技有限公司的阿达木单抗注射液(拟定商品名:闲康乐,研发代码:HOT-3010)上市申请获受理,受理号为CXSS2500115。值得注意的是,这是公司二次提交上市申请,此前上市审批未通过。一周前,华海生物的阿达木单抗注射液出现在中国国家药品监督管理局(NMPA)药品通知件送达信息中(受理号CXSS2400138,...

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