复星医药(600196.SH):汉利康获批新增500mg/50mL/瓶规格等
格隆汇4月24日丨复星医药(600196.SH)公布,近日,公司控股子公司上海复宏汉霖生物制药有限公司(“汉霖制药”)收到国家药品监督管理局颁发的关于利妥昔单抗注射液(即重组人鼠嵌合抗CD20单克隆抗体注射液,商品名称:汉利康®)的《药品补充申请批件》(批件号:2020B02885),获批新增500mg/50mL/瓶规格等。
该新药为集团自主研发的单克隆抗体药物,主要适用于非霍奇金淋巴瘤、类风湿关节炎的治疗。2019年度,集团汉利康®于中国境内(不包括港澳台地区,下同)的销售额约人民币1.5亿元。
截至公告日,于中国境内上市的利妥昔单抗注射液包括上海罗氏制药有限公司的美罗华®、汉霖制药的汉利康®。根据IQVIACHPA最新数据(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商;IQVIACHPA数据代表中国境内100张床位以上的医院药品销售市场,不同的药品因其各自销售渠道布局的不同,实际销售情况可能与IQVIACHPA数据存在不同程度的差异),2019年度,利妥昔单抗注射液于中国境内销售额约人民币25.05亿元。
截至2020年3月,集团现阶段针对该新药(包括非霍奇金淋巴瘤适应症及类风湿关节炎适应症)已投入研发费用人民币约59547万元(未经审计)。
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