復星醫藥：漢利康®與甲氨蝶呤聯合用於對一種及以上TNF-α抑制劑療效不佳的中重度活動性類風濕關節炎(RA)成人患者的上市註冊申請獲批
格隆匯3月1日丨復星醫藥(600196.SH)公佈，近日，公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司研製的利妥昔單抗注射液(即重組人鼠嵌合抗CD20單克隆抗體注射液，商品名：漢利康®；“該藥品”)與甲氨蝶呤聯合用於對一種及以上TNF-α抑制劑療效不佳的中重度活動性類風濕關節炎(RA)成人患者的上市註冊申請獲國家藥品監督管理局批准。
該藥品為集團自主研發的單克隆抗體藥物，除本次獲批註冊的適應症外，已於中國境內(不包括港澳台地區，下同)獲批上市的適應症還包括：(1)先前未經治療的CD20陽性III-IV期濾泡性非霍奇金淋巴瘤(應與化療聯合使用)、(2)初治濾泡性淋巴瘤經利妥昔單抗聯合化療後達完全或部分緩解後的單藥維持治療、(3)復發或化療耐藥的濾泡性淋巴瘤、(4)CD20陽性瀰漫大B細胞性非霍奇金淋巴瘤(DLBCL)(應與標準CHOP化療(環磷酰胺、阿黴素、長春新鹼、強的松)8個週期聯合治療)、(5)與氟達拉濱和環磷酰胺(FC)聯合治療先前未經治療或複發性/難治性慢性淋巴細胞白血病(CLL)。2020年度及2021年上半年，集團利妥昔單抗注射液於中國境內的銷售額分別約人民幣7.5億元、7.24億元。
截至公吿日，除本集團的該藥品外，於中國境內獲批上市的利妥昔單抗注射液還主要包括上海羅氏製藥有限公司的美羅華®、信達生物製藥(蘇州)有限公司的達伯華®，美羅華®及達伯華®尚未於中國境內獲批類風濕關節炎(RA)適應症。根據IQVIACHPA最新數據(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商；IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場，不同的藥品因其各自銷售渠道佈局的不同，實際銷售情況可能與IQVIACHPA數據存在不同程度的差異)，2021年度，利妥昔單抗注射液於中國境內的銷售額約人民幣31.51億元。
截至2022年1月，集團現階段針對該藥品(包括前述已獲批上市的適應症及本次獲批適應症)累計研發投入約人民幣68642萬元(未經審計)。
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.
