ProKidney Corp.披露重大进展：公司已与美国食品药品监督管理局（FDA）就加速审批路径达成一致，针对其候选药物Rilparencel。FDA明确接受eGFR斜率作为替代终点，适用于慢性肾病（CKD）和2型糖尿病患者群体，这将显著提速监管审查流程。激动人心的是，加速审批的顶线数据预计将于2027年第二季度发布。此外，FDA证实，第3阶段PROACT 1研究将同时支持加速审批和完全审批的双轨机制，为药物上市铺平道路。
ProKidney Corp.披露重大进展：公司已与美国食品药品监督管理局（FDA）就加速审批路径达成一致，针对其候选药物Rilparencel。FDA明确接受eGFR斜率作为替代终点，适用于慢性肾病（CKD）和2型糖尿病患者群体，这将显著提速监管审查流程。激动人心的是，加速审批的顶线数据预计将于2027年第二季度发布。此外，FDA证实，第3阶段PROACT 1研究将同时支持加速审批和完全审批的双轨机制，为药物上市铺平道路。
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