雙鷺藥業(002038.SZ):多西他賽注射液通過一致性評價
格隆匯4月26日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥監局核准簽發的關於多西他賽注射液《藥品補充申請批准通知書》,公司多西他賽注射液通過仿製藥質量和療效一致性評價。
多西他賽又名多西紫杉醇,屬於微管解聚抑制劑,是由Rhone-Poulenc Rorer公司開發的一個半合成紫杉醇衍生物,商品名泰索帝(TAXOTERE);臨牀上主要用於治療晚期乳腺癌、卵巢癌、非小細胞癌、對頭頸部癌、小細胞肺癌;對胃癌、胰腺癌、黑色素瘤等也有一定療效。多西他賽注射液由Rhone-Poulenc Rorer公司於1995年4月在墨西哥首次上市,現已在英、美、法、意、德、日等主要國家上市,1998年獲歐盟和美國FDA批准進入歐洲及美國市場。2010年在中國上市,由賽諾菲安萬特公司生產。
目前進口藥品在國內上市規格有1.0ml:20mg和0.5ml:20mg(另附1支溶劑1.5ml)兩種。目前國內上市並通過一致性評價的生產企業有江蘇恆瑞醫藥股份有限公司、正大天睛藥業集團股份有限公司、齊魯製藥有限公司、揚子江藥業集團有限公司、江蘇奧賽康藥業有限公司、四川匯宇製藥股份有限公司、上海創諾製藥有限公司、四川美大康佳樂藥業有限公司等多家企業。公司2020年、2021年該產品的銷售額分別是2508.80萬元和1358.33萬元。
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 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.