智通财经APP讯，迈博药业-B(02181)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。
CMAB807X类舒®(地舒单抗注射液)为迈博药业获批上市的第四款产品CMAB807普博力®(地舒单抗注射液)的另一规格药品。公司将与合作伙伴密切配合，迅速推动CMAB807X类舒®(地舒单抗注射液)的中华人民共和国国家医保计划准入和市场渠道拓展，快速实现该产品的市场覆盖和放量，预计该产品将为公司药品销售和利润增长提供很大的助力。公司亦已经启动CMAB807X类舒®(地舒单抗注射液)海外市场推广和注册活动，并预期CMAB807X类舒®(地舒单抗注射液)在海外市场亦将取得不俗的销售业绩。
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