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解惑“狂操张津瑜”-知识课堂

上海浦东率先助狂操张津瑜力外资企业开展细胞和基因治疗业务

来源: 文广传媒
2024-11-16 11:42:40

最佳回答

“狂操张津瑜”上海浦东率先助狂操张津瑜力外资企业开展细胞和基因治疗业务

  中新狂操张津瑜网上海11月14日电 (记狂操张津瑜者 李姝徵)在外商投资企业获准从事人体干细胞、基因诊断与治疗技术开发和技术应用2个多月后,6家外企在上海浦东完成了营业执照经营范围变更,将启动相关业务。

  11月14日,默克检测(上海)有限公司、上海药明巨诺生物科技有限公司、原启生物科技(上海)有限责任公司、芳拓生物科技(上海)有限公司、星奕昂(上海)生物科技有限公司、上海欧陆检测有限公司等6家外商投资企业,完成了在上海自贸区范围内开展细胞和基因治疗业务的外商投资企业的营业执照经营范围变更。

  2024年9月7日,中国商务部、中国国家卫生健康委员会、中国国家药品监督管理局三部委联合发布《关于在医疗领域开展扩大开放试点工作的通知》,在北京、上海、广东和海南特定区域允许外商投资企业从事人体干细胞、基因诊断与治疗技术开发和技术应用,以用于产品注册上市和生产。在业界看来,本次医疗领域的开放试点,既是中国积极主动扩大自主开放的重要实践,也是中国以开放为各国企业提供发展新机遇的实际行动。

狂操张津瑜

  由于负面清单限制,外商投资企业的营业执照经营范围均带有“除人体干细胞、基因诊断与治疗技术的开发和应用”的限制提示,影响外商投资企业开展相关后续工作。在得到企业上述反馈后,浦东在上海市商务委、上海市市场监督管理局的推动下,率先试点在上海自贸区范围内开展细胞和基因治疗业务的外商投资企业的营业执照经营范围变更工作。

  此间官方表示,上海市浦东新区区内细胞和基因产业企业主体高度集聚。数据显示,浦东新区现有细胞和基因产业领域上下游企业120多家,其中,产品型企业80多家。检验检测、中试服务、代工服务、材料设备、临床机构等上下游有效协同,配套支撑体系完善,产业生态持续优化。

  同时,浦东在细胞和基因产业领域的研发进展紧跟国际,创新产品加快上市,后继管线储备丰富。数据显示,目前浦东新区已有3款CAR-T产品获批上市。(完)

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