Scholar Rock控股公司迎来重大利好——日本药品和医疗器械管理局(PMDA)已明确表态,认为无需再进行额外的临床研究。这一进展为该公司旗下在研药物Apitegromab的日本上市之路扫清了关键障碍。据此,Scholar Rock计划于2026年底前正式向PMDA提交该药物的上市许可申请(JNDA)。此举标志着公司在全球战略布局中迈出了坚实一步,尤其在亚太核心市场的推进节奏上,展现出明确的执行力与前瞻性。
Scholar Rock控股公司迎来重大利好——日本药品和医疗器械管理局(PMDA)已明确表态,认为无需再进行额外的临床研究。这一进展为该公司旗下在研药物Apitegromab的日本上市之路扫清了关键障碍。据此,Scholar Rock计划于2026年底前正式向PMDA提交该药物的上市许可申请(JNDA)。此举标志着公司在全球战略布局中迈出了坚实一步,尤其在亚太核心市场的推进节奏上,展现出明确的执行力与前瞻性。
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