智通财经APP获悉，博安生物(06955)午后涨超4%，截至发稿，涨4.13%，报10.34港元，成交额3168.6万港元。
消息面上，博安生物宣布，公司自主研制的骨科领域的地舒单抗注射液60mg(BA6101)和肿瘤领域的地舒单抗注射液120mg(BA1102)的英国上市许可申请已获得英国药品和医疗健康产品管理局(MHRA)受理。博安生物将BA6101与BA1102视为全球开发战略中的核心产品，公司将向欧洲药品管理局(EMA)、美国食品药品监督管理局(FDA)、日本医药品医疗器械综合机构(PMDA)等国际药品监管机构提交该两款产品的上市申请。
基于广泛的临床需求及良好的临床价值等多种因素，地舒单抗在全球范围内呈现广阔的市场前景。公开数据显示，2024年Prolia与Xgeva全球销售额合计约66亿美元。为支撑全球商业化目标，公司已建立起一整套符合中国及欧美日国际相关标准的质量管理体系，为地舒单抗以及后续更多生物药的成功出海提供品质保障。
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