生物技术公司Solid Biosciences近日宣布，其针对杜氏肌营养不良症研发的基因治疗候选药物SGT-003，已正式获得欧盟委员会颁发的孤儿药资格认定。这一认定标志着该疗法在欧盟地区药物开发进程中的重要监管进展。
孤儿药资格认定旨在鼓励针对罕见病创新疗法的开发。获得该认定后，Solid Biosciences将在药物后续临床开发、注册审批及上市后阶段享受欧盟多项政策支持，包括协议协助、费用减免以及上市后十年的市场独占权。
SGT-003作为该公司基因治疗管线的重要候选药物，此次获得欧盟监管机构的认可，为其在欧洲市场的战略布局奠定了坚实基础。该认定将加速推进SGT-003在全球范围内的临床开发计划，为杜氏肌营养不良症患者提供新的治疗希望。
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