健康元(600380.SH)获得药物临床试验批准通知书

智通财经05-06

智通财经APP讯，健康元(600380.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意公司申报的新型β-内酰胺酶抑制剂开展临床试验。

根据《中华人民共和国药品管理法》及有关规定，经审查，2026年2月12日受理的注射用JKN2501临床试验申请符合药品注册的有关要求，同意本品开展拟与美罗培南联用，用于治疗革兰氏阴性菌或革兰氏阳性菌引起的医院获得性肺炎和呼吸机相关性肺炎(HAP/VAP)的临床试验。

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