这一药品 全面停产、停售

2019-02-12 小婉 赛柏蓝

中国医药作出回应:上海新兴医药已全面停产、停售,对上市公司影响较小该产品,全面停产、停售前日(2月10日),中国医药发布公告,对其下属控股子公司上海新兴静注人免疫球蛋白事件作出说明。公告显示,在得知消息后, 上海新兴全面停产 ,全面排查问题批次产品的原料来源、生产及质量控制全流程等各重要环节中可能存在的问题。此外, 上海新兴通知相关单位全面停止销售、使用、封存并召回问题批次产品,同时对问题批次产品

中国医药作出回应:上海新兴医药已全面停产、停售,对上市公司影响较小

该产品,全面停产、停售

前日(2月10日),中国医药发布公告,对其下属控股子公司上海新兴静注人免疫球蛋白事件作出说明。

公告显示,在得知消息后, 上海新兴全面停产 ,全面排查问题批次产品的原料来源、生产及质量控制全流程等各重要环节中可能存在的问题。

此外, 上海新兴通知相关单位全面停止销售、使用、封存并召回问题批次产品,同时对问题批次产品的使用情况进行全面清查 。上海新兴立即开展自查,配合相关部门的核查工作,确保生产和质量控制原始记录的真实性和完整性。

这意味着,这个新年里引起人们高度关注的产品,全面停产、停售。

经营规模和利润占比不大,对母公司影响较小

据了解,人免疫球蛋白是一种由人的血浆制备的血液制品,主要用于危重感染和免疫缺陷患者的治疗。

本批次静注人免疫球蛋白(批号 :20180610Z )于 2018 年 10 月 12 日由上海市食品药品检验所批签, 共计 12226 瓶,规格为 5% , 2.5g/50ml/ 瓶。保质期到 2021 年 6 月 8 日。

与此同时,中国医药称: 上海新兴医药经营规模及利润在公司中占比不大,对公司影响较小。

据中国医药披露的数据显示,截至 2018 年 9 月底,上海新兴合并口径资产总计 3.84 亿元,占公司资产总额的 1.5% ,净资产总计 3.61 亿元,占公司净资产总额的 3.6% 。

2018 年 1-9 月,上海新兴合并口径累计实现营业收入 1.53 亿元,占公司营业收入总额的 0.69% 。实现净利润 7183 万元,归属于其母公司的净利润为 3663 万元,占公司归属于上市公司股东的净利润总额的 2.95% 。

然而,需要注意的是,就上海新兴而言,静注人免疫球蛋白这个品种,在上海新兴的主要产品收入构成中占据相对较大的份额。

暂停采购,各地开始了

2月11日,浙江省药械采购中心发布通知:暂停采购和使用上海新兴医药股份有限公司部分产品。

通知显示,为及时控制风险,保护群众健康,请各医疗机构和药品配送企业立即暂停采购和使用相关产品,并按规定立即采取封存等控制措施。

其中,暂停采购及使用的上海新兴医药股份有限公司产品信息如下:

静注人免疫球蛋白(批号20180610Z); 人血白蛋白(批号20180411A、20180412A);人凝血酶原复合物(批号20180411P、20180412P)。

此外, 2 月 5 日,陕西省卫健委发布紧急通知:要求暂停使用上海新兴医药股份有限公司相关批号的静注人免疫球蛋白,并对产品进行封存。

实际上,最早是江西省疾控中心发现了上海新兴医药公司生产的静注人免疫球蛋白(批号: 20180610Z )艾滋病毒抗体呈阳性,并停用相关批号的产品。

第二天,三部门连发公告作出回应:已第一时间派出工作组赴地方指导工作,并召集专家对有关问题进行分析研判。

上海方面对涉事批次静注人免疫球蛋白进行的艾滋病、乙肝、丙肝三种病毒核酸检测,结果均为阴性;江西方面对患者的艾滋病病毒核酸检测,结果为阴性。对企业现场核查等有关工作正在进一步进行中。

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    2019-02-12 Y—xianghai

    学习了新知识

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    2019-02-12 Y—xianghai

    学习了长知识

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    2019-02-12 Y—xianghai

    学习了新知识

    0

  4. 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    2019-02-12 Y—xianghai

    学习了长知识

    0

  5. 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    2019-02-12 Y—xianghai

    学习了新知识

    0

  6. 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    2019-02-12 Y—xianghai

    学习了长知识

    0

  7. 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    2019-02-12 Y—xianghai

    学习了新知识

    0

  8. 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    2019-02-12 Y—xianghai

    学习了长知识

    0

  9. 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    2019-02-12 Y—xianghai

    学习了新知识

    0

  10. 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    2019-02-12 Y—xianghai

    学习了长知识

    0

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