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中国同辐(01763):中核海得威新型尿素13C呼气试验药盒取得临床试验批准通知书

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中国同辐(01763)发布公告,近日,经国家药品监督管理局正式批准,深圳市中核海得威生物科技有限公司新型尿素13C呼气试验药盒顺利取得了药物临床试验批准通知书。

自2017年中共中央办公厅、国务院办公厅发佈的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》药品管理新规实施以来,中核海得威研制的新型尿素13C呼气试验药盒是国内首家申报并取得临床试验批准通知书的同类药品。中核海得威以研发驱动创新的发展新路径,通过不断开发新药品,进一步提升核心竞争力。

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