You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
奧賽康(002755.SZ):多西他賽注射液通過仿製藥一致性評價
格隆匯 05-11 22:26

格隆匯5月11日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的多西他賽注射液《藥品補充申請批准通知書》,批該藥品通過仿製藥質量和療效一致性評價。

多西他賽是由法國賽諾菲公司開發的一種半合成紫杉烷類抗腫瘤藥物。多西他賽注射液1995年在墨西哥、歐洲獲批上市,於19965月在美國批准上市;至今,已在全球多個國家上市,用於乳腺癌、非小細胞肺癌、前列腺癌、胃癌和頭頸部腫瘤等多個適應症,並已成為這些癌種治療的最常用或標準療法之一。1998年原研多西他賽注射液開始在國內上市銷售。2005公司的多西他賽注射液(奧名潤)獲批上市。

多西他賽通過干擾細胞有絲分裂和分裂間期細胞功能所必需的微管網絡而起抗腫瘤作用,多西他賽比紫杉醇更容易被細胞攝取,抑制微管解聚能力是紫杉醇的2倍。多西他注射液是國內治療腫瘤的常用藥物之一,入選《國家基本醫療保險、工傷保險和生育保險藥品目錄》。公司研製的多西他賽注射液的規格1ml:20mg,具有無需二次稀釋、臨牀使用方便的優勢。PDB數據庫顯示2020年樣本醫院銷售額為11.12億元。多西他賽注射液的市場成熟且規模較大。

根據國家相關政策,通過一致性評價的藥品,質量和療效等同原研產品,在醫保支付及醫療機構採購方面將予以適當支持。在國家鼓勵優先採購和使用通過一致性評價的產品的政策背景下,多西他射液通過仿製藥一致性評價有利於進一步增強該藥品的技術優勢,提升市場競爭力,擴大市場份額。同時為公司及子公司後續一致性評價產品研究甚至仿製藥開發積累了寶貴經驗。

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.
uSMART
Wealth Growth Made Easy
Open Account