復星醫藥(600196.SH):用於晚期惡性實體瘤治療的FH-2001膠囊獲批開展I期臨牀試驗
格隆匯8月9日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復星醫藥產業發展有限公司(“復星醫藥產業”)收到國家藥品監督管理局關於同意其參與研製的FH-2001膠囊(“該新藥”)用於晚期惡性實體瘤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I期臨牀試驗。
該新藥為PD-L1/FGFR 雙機制小分子調節/抑制劑,擬主要用於治療晚期實體瘤;該新藥臨牀前研究主要由上海藥明康德新藥開發有限公司受託開展、臨牀研究及後續商業化擬由集團自主實施。
截至公吿日,全球範圍內尚無靶向PD-L1小分子抑制劑獲批上市;中國境內已上市的FGFR小分子抑制劑主要包括侖伐替尼、瑞戈非尼及帕唑帕尼等。根據IQVIA CHPA 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;IQVIA CHPA 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IQVIA CHPA 數據存在不同程度的差異),2020 年度,侖伐替尼、瑞戈非尼及帕唑帕尼等於中國境內的銷售額約人民幣90668萬元。
截至2021年7月,集團現階段針對該新藥累計研發投入約人民幣4253萬元人民幣(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.