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.
科倫藥業(002422.SZ):吉非替尼片獲藥品註冊批件
格隆匯 12-12 15:42

格隆匯12月12日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“吉非替尼片”的《藥品註冊批件》。

藥品名稱:吉非替尼片;劑型:片劑;規格:0.25g;申請事項:國產藥品註冊;註冊分類:化學藥品4類;申報階段:生產;受理號:CYHS1700284;藥品批准文號:國藥準字H20193362;審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品批准文號。

吉非替尼是全球首個上市的表皮生長因子受體小分子酪氨酸激酶抑制劑(EGFR-TKI),2003年美國批准,2004年國內批准進口,用於EGFR基因敏感突變的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療。與傳統化療方案相比,吉非替尼可顯著提高EGFR突變患者的客觀緩解率、延長無進展生存期,且總體耐受性良好。

吉非替尼臨牀應用廣泛,目前已被《NCCN非小細胞肺癌臨牀實踐指南(2020.V1)》、《中國臨牀腫瘤學會(CSCO)原發性肺癌診療指南(2019)》等指南推薦作為EGFR突變非小細胞肺癌患者的一線治療藥物,且已進入2019年國家乙類醫保和2018年國家基藥目錄,2018年中國銷售額為30.6億元。

公司吉非替尼片為2015年國家藥監政策改革後,按照仿製藥必須與原研一致的要求研究、申報與獲批,質量和療效與原研(商品名:易瑞沙/IRESSA,AstraZeneca UK Limited生產)等同。

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