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.
李氏大藥廠(00950.HK):SOCAZOLIMAB獲國家藥監局批准開展一項三期臨牀試驗
格隆匯 03-05 22:30

格隆匯3月5日丨李氏大藥廠(00950.HK)發佈公吿,於2021年3月1日,公司附屬公司中國腫瘤醫療有限公司(COF)獲中國國家藥品監督管理局批准臨牀試驗申請,以對結合化療一線治療擴散期小細胞肺癌的Socazolimab(抗PD-L1單克隆抗體,前稱ZKAB001)進行多中心、隨機、雙盲、並行組別的第三期臨牀試驗。該批准的依據為先前第一b期試驗的結果,當中結合卡鉑和依託泊苷的Socazolimab在擴散期小細胞肺癌患者中表現出良好的療效及安全性。此臨牀試驗將由上海市胸科醫院陸舜教授牽頭,預期將於2021年第二季度開展患者招募。

Socazolimab為獲Sorrento Therapeutics,Inc授權於中國、香港、澳門及台灣生產的引進藥品。至今,已完成三項第一期Socazolimab單藥療法臨牀試驗:(1)複發性或轉移性宮頸癌;(2)晚期泌尿上皮癌;及(3)高級別骨肉瘤患者輔助化療後維持治療。

有關複發性或轉移性宮頸癌的試驗研究已完成,並於2021年二月獲得國家藥監局突破性療法認定。公司預期於2021年第二季度提交Socazolimab治療複發性或轉移性宮頸癌的新藥申請。除單藥療法外,若干項Socazolimab結合化療的研究正在進行中,包括晚期泌尿上皮癌(第一b期)、擴散期小細胞肺癌(第三期)以及食道癌(第一b╱二期)的新輔助治療。

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.
uSMART
Wealth Growth Made Easy
Open Account