复星医药(02196.HK)：类风湿关节炎(RA)治疗药品利妥昔单抗注射液获药品注册申请受理
格隆汇 12 月 17日丨复星医药(02196.HK)发布公告，近日，公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司研制的利妥昔单抗注射液(即重组人鼠嵌合抗CD20单克隆抗体注射液，以下简称“该新药”)用于类风湿关节炎(RA)治疗获国家药品监督管理局药品注册申请受理。
该新药为集团自主研发的单克隆抗体药物，于中国大陆(不包括港澳台地区，下同)已获批上市的适应症为：(1)复发或耐药的滤泡性中央型淋巴瘤、(2)先前未经治疗的CD20阳性III-IV期滤泡性非霍奇金淋巴瘤、(3)CD20阳性弥漫大B细胞性非霍奇金淋巴瘤(DLBCL)、(4)初治滤泡性淋巴癌患者经利妥昔单抗联合化疗后达完全或部分缓解后的单药维持治疗、(5)与氟达拉滨和环磷酰胺(FC)联合治疗先前未经治疗或复发性/难治性慢性淋巴细胞白血病(CLL)患者。2019年度，该新药于中国大陆的销售额约为人民币1.5亿元。截至概公告日，该新药用于类风湿关节炎(RA)治疗已完成III期临床研究，且已达到预设的主要研究终点。
截至概公告日，于中国大陆获批上市的利妥昔单抗注射液主要包括上海罗氏制药有限公司的美罗华®、上海复宏汉霖生物制药有限公司的汉利康®、信达生物制药(苏州)有限公司的达伯华®；于中国大陆获批上市的利妥昔单抗注射液尚无获批类风湿关节炎适应症。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数据代表中国大陆100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大陆销售额约为人民币25.07亿元。截至2020年11月，集团现阶段针对该新药(包括已获批上市的适应症及类风湿关节炎适应症)累计研发投入约为人民币65,815万元(未经审计)。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
