復星醫藥(02196.HK)子公司Balixafortide用於與艾立布林聯合治療HER2陰性、局部復發或轉移性乳腺癌獲藥品臨牀試驗批准
格隆匯6月10日丨復星醫藥(02196.HK)發佈公吿,近日,公司控股子公司上海復星醫藥產業發展有限公司收到國家藥品監督管理局關於同意集團獲許可的Balixafortide用於與艾立布林聯合治療HER2陰性、局部復發或轉移性乳腺癌開展臨牀試驗的批准。復星醫藥產業擬於條件具備後於中國境內(不包括港澳台,下同)開展該新藥的臨牀試驗。
公司控股子公司Fosun Pharmaceutical AG於2020年8月獲Polyphor Ltd關於CXCR4拮抗劑Balixafortide及其相關產品/組合在中國大陸及港澳台的獨家臨牀開發、商業化許可,且FosunPharma AG有權將其被授予的權利再許可給其關聯方及經Polyphor書面同意的其他第三方。
截至本公吿日,Balixafortide聯用艾立布林針對HER2陰性轉移性乳腺癌適應症已於美國等地完成Ib期臨牀研究,並正在開展針對該適應症的全球多中心III期臨牀研究。Balixafortide聯用艾立布林用於治療HER2陰性轉移性乳腺癌已獲得美國食品藥品監督管理局(即美國FDA)的快速通道(FastTrack)資格。
截至本公吿日,於中國境內尚無用於乳腺癌適應症的CXCR4拮抗劑獲批上市。截至2021年5月,集團現階段針對該新藥累計研發投入按2021年5月31日中國人民銀行公佈的匯率中間價摺合人民幣約9,646萬元。
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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.