普肾公司（NASDAQ：PROK）于7月15日宣布与美国食品药品监督管理局（FDA）达成重要监管共识，其自主研发的肾安细胞疗法（rilparencel）获得加速审批路径确认。该自体细胞疗法旨在延缓晚期慢性肾脏病（CKD）合并2型糖尿病患者的肾功能衰退。
此次加速审批将以正在进行的III期PROACT 1研究作为主要依据，该试验已招募近半计划受试者。关键审批分析将采用估算肾小球滤过率（eGFR）斜率作为替代终点。支持加速审批申请的顶线数据预计于2027年第二季度公布。
这款突破性疗法针对存在高度未满足临床需求的疾病领域，加速审批路径的确立标志着普肾公司在解决晚期慢性肾病治疗难题方面取得标志性进展。肾安细胞疗法通过患者自身肾祖细胞进行自体移植，有望改变当前依赖透析和肾移植的传统治疗格局。
根据监管协议，若III期研究证实该疗法能显著延缓肾功能下降，普肾公司将有望通过加速通道提前实现产品商业化。目前全球约有8.5亿慢性肾病患者，其中糖尿病肾病占比超30%，该疗法若获批将覆盖庞大患者群体。
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