特寶生物(688278.SH):派格賓新增適應症獲得藥物臨牀試驗批准通知書
格隆匯7月7日丨特寶生物(688278.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於公司藥品派格賓(通用名稱:聚乙二醇干擾素α-2b注射液)新增適應症“原發性血小板增多症”的《藥物臨牀試驗批准通知書》。
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2024年4月28日受理的聚乙二醇干擾素α-2b注射液臨牀試驗申請符合藥品註冊的有關要求,同意本品開展原發性血小板增多症的臨牀試驗。
派格賓是公司目前的核心產品,是公司自主研發、我國首個國產上市的聚乙二醇長效干擾素α-2b注射液,是治療用生物製品1類新藥。派格賓於2016年10月獲批上市,獲批適應症為“用於治療慢性丙型肝炎成年患者”,2017年9月獲得增加適應症“適用於治療成人慢性乙型肝炎”的補充申請註冊批件,本次臨牀試驗申請新增的適應症為“原發性血小板增多症”。
根據《原發性血小板增多症診斷與治療中國專家共識》,干擾素可用於對羥基脲耐藥或不耐受的患者進行治療。派格賓為長效干擾素,採用了40kD的聚乙二醇結構,具有優良的藥代動力學優勢,維持長時間的血藥濃度平穩,保證了一週給藥一次,提高了患者用藥的便利性和依從性。
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.