恆瑞醫藥(600276.SH):注射用卡瑞利珠單抗新增適應症獲批
格隆匯6月10日丨恆瑞醫藥(600276.SH)宣佈,公司子公司蘇州盛迪亞生物醫藥有限公司近日收到國家藥監局核准簽發的關於注射用卡瑞利珠單抗的《藥品註冊證書》。注射用卡瑞利珠單抗是人源化抗PD-1單克隆抗體,可與人PD-1受體結合並阻斷PD-1/PD-L1通路,恢復機體的抗腫瘤免疫力,從而形成癌症免疫治療基礎。
根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准本品增加以下適應症,具體為“聯合順鉑和吉西他濱用於局部復發或轉移性鼻咽癌患者的一線治療”。本次新增適應症的Ⅲ期臨牀試驗同時作為本品三線鼻咽癌適應症的確證性臨牀試驗,支持本品三線鼻咽癌適應症已達到附條件批准時的所附條件要求。
經查詢,目前國外有4款PD-1單克隆抗體獲批上市,分別為帕博利珠單抗(默沙東,商品名可瑞達),納武利尤單抗(百時美施貴寶,商品名歐狄沃),cemiplimab(再生元製藥,商品名Libtayo)和dostarlimab(葛蘭素史克,商品名Jemperli),帕博利珠單抗和納武利尤單抗均已在國內獲批上市。除恆瑞醫藥外,國內另有3款PD-1單克隆抗體獲批上市,分別為特瑞普利單抗(上海君實,商品名拓益,2018年獲批),信迪利單抗(信達生物,商品名達伯舒,2018年獲批)和替雷利珠單抗(百濟神州,商品名百澤安,2019年獲批)。
經查詢EvaluatePharma數據庫,2020年抗PD-1抗體全球銷售額約為237.6億美元。截至目前,注射用卡瑞利珠單抗相關項目累計已投入研發費用約為14.90億元。
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.