李氏大藥廠(00950.HK)引進並研發一種研究性腫瘤藥物
格隆匯 7 月 16日丨李氏大藥廠(00950.HK)發佈公告,2020年7月10日,集團的附屬公司中國腫瘤醫療有限公司(“COF”)已向國家藥品監督管理局提交申請,以認定ZKAB001(一種抗程式性死亡配體1(PD-L1)單克隆抗體)為用於治療復發及轉移性宮頸癌的突破性治療藥物。
國家市場監督管理總局(藥監局的上級機構)於2020年3月30日公佈,並於2020年7月7日起施行新修訂的《藥品註冊管理辦法》。經修訂藥品註冊管理辦法為突破性治療藥物打通優先審評審批、附條件批准及特別審批程序等監管途徑,並擴大對突破性治療藥物的優先審評。突破性治療藥物指用於防治嚴重影響生存質量或者嚴重危及生命且尚無有效防治手段的疾病,或者有足夠證據表明相比現有治療方法具有明顯臨牀優勢的藥物。
中國每年有超過100,000宗新發宮頸癌病例、近30,000名婦女死於宮頸癌。一線治療後的複發率極高。中國乃至全世界對於新的標準治療方法有迫切的醫療需要。隨着免疫檢測點抑制劑迅速發展,抗PD-L1抗體ZKAB001可望成為有需要患者的新希望。
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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.