前沿生物(688221.SH):FB4001特立帕肽注射液ANDA申請獲得美國FDA受理
格隆匯2月28日丨前沿生物(688221.SH)公佈,近日,公司收到美國食品藥物管理局下發的關於公司在研產品FB4001特立帕肽注射液的ANDA(美國新藥簡略申請,即美國仿製藥申請)註冊申請《受理通知書》。
FB4001為特立帕肽注射液仿製藥,特立帕肽是一種人甲狀旁腺激素重組多肽衍生物,生理學作用包括直接作用於成骨細胞刺激骨骼形成、改善骨密度與質量,間接增加腸道鈣的吸收,增加腎小管鈣的重吸收和增強磷酸鹽在腎臟的排泄。
特立帕肽注射液用於治療具有高骨折風險的絕經後婦女及男性骨質疏鬆症患者,也可用於具有高骨折風險的糖皮質激素相關的骨質疏鬆症患者。隨着全球人口老齡化的快速進展,中老年羣體骨質疏鬆症高發,預計治療骨質疏鬆類的藥物依舊存在較大的市場潛力。
公司在充分調研美國特立帕肽仿製藥的註冊獲批情況後,優化註冊路徑,向美國FDA提出FB4001的CGT認定申請並獲批,CGT是全新的、唯一針對仿製藥開通的特殊通道,旨在鼓勵競爭不充分的仿製藥的申報,獲得CGT認定可享有加速仿製藥批准,180天的市場獨佔期等優惠政策,對推進仿製藥上市進程具有重大意義。
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.