Scholar Rock Holding Corp 与欧洲药品管理局沟通,计划将第二家灌装-封装设施纳入Apitegromab上市申请

美股速递
Aug 08

Scholar Rock Holding Corp 正积极与欧洲药品管理局(EMA)展开沟通。该公司旨在将第二处灌装-封装生产设施,纳入其实验性药物Apitegromab的上市许可申请(MAA)中。这一举措,凸显了其对于扩大生产能力的战略布局。通过此举,公司期望能优化供应链韧性,并确保未来药物获批后的稳定供应。此举不仅关乎生产规模,更体现了对监管流程的深度参与与前瞻性规划。

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