基石藥業-B(02616.HK):合作伙伴胃腸道間質瘤靶向藥AYVAKIT™獲美國FDA批准上市
格隆匯1月15日丨基石藥業-B(02616.HK)公佈,公司的合作伙伴Blueprint Medicine Corporation(納斯達克股票代碼:BPMC)(“Blueprint Medicine”),一家專注於探索具有特定基因特徵的癌症、罕見病及癌症免疫療法的精準治療的公司,宣佈其研發產品AYVAKIT™(avapritinib)已於2020年1月9日獲美國食品藥品監督管理局(“美國FDA”)批准上市,用於治療攜帶PDGFRA外顯子18突變(包括PDGFRA D842V突變)的不可手術切除或轉移性胃腸道間質瘤(“GIST”)成人患者。avapritinib由Blueprint Medicine研發。
基石藥業董事長、執行董事兼首席執行官江寧軍博士表示:“很高興看到我們在中國與Blueprint Medicine的合作產品avapritinib在美國獲批,這也是基石藥業產品管線內第二款獲美國FDA批准上市的產品。公司計劃在2020年針對同一適應症向國家藥品監督管理局(“NMPA”)遞交新藥上市申請,以滿足國內具有特定基因特徵的GIST患者的治療需求。”
基石藥業與Blueprint Medicine達成獨家合作和授權,獲得了包括avapritinib在內的三款藥物在中國大陸、香港、澳門和台灣的獨家開發和商業化授權。Blueprint Medicine保留在世界其他地區開發及商業化該三款藥物的權利。
目前,avapritinib共有兩項針對GIST的註冊性試驗正在中國開展,其中一項針對avapritinib用於GIST三線治療方案的名為“VOYAGER”的III期臨牀研究在四個月內即完成了中國患者入組。基石藥業也將於2020年下半年向NMPA就avapritinib用於GIST三線治療方案遞交新藥上市申請。
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.