迈博药业-B(02181.HK):CMAB807X类舒®(地舒单抗注射液)的上市注册申请获批

智通财经
Jun 24
【迈博药业-B(02181.HK):CMAB807X类舒®(地舒单抗注射液)的上市注册申请获批】智通财经APP讯,迈博药业-B(02181.HK)公布,近日,公司管线产品CMAB807X类舒®(地舒单抗注射液)的上市注册申请(NDA)已获中华人民共和国国家药品监督管理局批准,用于(i)实体肿瘤骨转移患者或多发性骨髓瘤患者的治疗,以延迟或降低骨相关事件(病理性骨折、嵴髓压迫、骨放疗或骨手术)的发生风险及(ii)治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤,包括成人和骨骼发育成熟(定义为至少1处成熟长骨且体重≥45kg)的青少年患者。

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