4月6日，再生医学领域迎来重要进展——Organogenesis Holdings Inc宣布已成功完成与美国食品药品监督管理局（FDA）的专题会议，并就其创新产品Renu®用于膝骨关节炎疼痛治疗达成关键共识。此次突破性会议为后续申报流程扫清了道路。
根据会议结果，该公司计划启动滚动式生物制品许可申请（BLA）程序，这一战略性安排将分阶段提交申报资料，有望加速审评进程。目前企业目标明确：在2025年底前完成Renu®的BLA全部提交工作，其中首次申报环节预计将于今年12月底前启动。
Renu®作为针对膝骨关节炎疼痛的先进疗法，若最终获批，将填补该领域长期存在的治疗空白。此次FDA会议的积极成果，不仅印证了产品的临床价值，也为后续商业化布局奠定了监管基础。
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