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                                                                                                                                                                          银河平台娱乐网址:上海新兴公司血液制品艾滋病抗体检测阳性 为药监局重点监管企业

                                                                                                                                                                          2019年02月06日 12:55 来源:安驰美术网

                                                                                                                                                                            经济日报-中国经济网2月6日讯(记者 朱国旺) 2月5日,有媒体报道称,部分省市医疗机构接到名为《关于暂停使用上海新兴医药股份有限公司相关批号静注人免疫球蛋白的通知》文件,其中提到,上海新兴医药股份公司生产的20180610Z批号静注人免疫球蛋白被检测出艾滋抗体阳性,要求立即停用。据了解,该批静注人免疫球蛋白共有12226瓶,签发日期为2018年10月12日。

                                                                                                                                                                            人免疫球蛋白主要由人血浆提取,用于免疫低下的人群提高免疫力,也可用于治疗自身免疫病。如先天性丙种球蛋白缺乏症、易变型免疫缺陷症、免疫球蛋白合成异常的细胞缺陷症;治疗大面积烧伤、严重创伤感染,以及败血症或内毒素血症。

                                                                                                                                                                            北京大学医学部免疫学系副主任王月丹接受新京报记者采访时表示:“血液制品检出艾滋病抗体,应该就是意味着被来自HIV感染者的血液或者其成分污染了。理论上,其传播HIV的风险是存在的。”

                                                                                                                                                                            上海新兴医药公司系国家血液制品定点生产企业,主要从事血液制品的生产和销售,是一家集科研、生产、销售为一体的高科技外向型生物医药企业。公司成立于2000年8月,由中国新兴(集团)总公司等单位共同发起,在原解放军总后卫生部上海新兴血液制品研究所基础上改制而成,注册资本1.64亿元,于2009年随新兴集团整体重组并入中国通用技术集团。现由中国医药(600056)健康产业股份有限公司(中国医药600056)控股管理。

                                                                                                                                                                            据国家药监局官网信息,早在2005年,原国家食品药品监管局开始对特殊药品和血液制品生产企业实施重点监管,上海新兴医药股份公司系重点监管的血液制品生产企业。原国家食品药品监管局要求,各省级食品药品监督管理局应确定一名局领导和一名负责特殊药品和血液制品监管的工作人员联系企业,并组织企业所在地设区的市级食品药品监督管理局共同参与,对企业执行有关法律、法规情况及特殊药品和血液制品生产、销售等情况定期进行检查,发现问题及时予以纠正,确保特殊药品合法需求,杜绝流入非法渠道。加强对原料血浆来源和质量的监管,防止血液制品生产的交叉污染。并对企业的投料、纯化和制剂生产实行月报表制度。