康哲藥業(00867.HK):亞甲藍腸溶緩釋片中國註冊上市許可申請已獲受理
格隆匯2月15日丨康哲藥業(00867.HK)公吿,集團創新專利藥亞甲藍腸溶緩釋片("亞甲藍腸溶緩釋片"或"產品")註冊上市許可申請已於2023年2月15日獲得中國國家藥品監督管理局(NMPA)受理。
亞甲藍腸溶緩釋片為一種口服的診斷藥物,適用於在接受篩查或監測結腸鏡檢查的成年患者中增強結直腸病變的可視化,可顯著提高非息肉樣結直腸病變檢出率。產品中國III期臨牀研究取得了積極結果。主要研究終點非息肉樣結直腸病變檢出率(至少發現一處組織學證實的非息肉樣結直腸病變的受試者比例)結果顯示,試驗組(施予產品)為51.0%,對照組(施予安慰劑)為41.2%,兩組差異具有統計學意義(P<0.0001),且假陽性控制良好。
亞甲藍腸溶緩釋片已於2020年8月被歐洲藥品管理局(EMA)批准以Lumeblue™的商品名在歐盟商業化。
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.