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Aprogen退行性关节炎新药AP209拟8月初启动患者给药
发布: · 来源: mk.co.kr
一句$话总结: Aprogen表示，已于3月向韩国食品医药品安全处提交退行性关节炎新药AP209临床试验批准申请，预计最快5月底或6月初获批。
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Aprogen表示，公司正在推进其开发中的退行性关节炎新药AP209临床试验批准程序，患者给药计划于8月初进行。公司已于3月向韩国食品医药品安全处提交AP209临床试验批准申请，目前正处于协商和补充资料阶段。Aprogen预计，临床批准最快可能在5月底、最迟在6月初取得。若获批后患者给药按计划启动，AP209的开发将进入临床阶段。不过，公司所披露的时间表仍可能因与监管机构的协商及补充程序进展而发生变化。来源: mk.co.kr
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