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):創新藥SKB264聯合KL-A167獲批開展臨牀試驗
格隆匯 03-31 19:41

格隆匯3月31日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司科倫博泰開發的創新藥物SKB264(TROP2-ADC)聯合KL-A167(PD-L1單抗)加或不加鉑類治療晚期或轉移性非小細胞肺癌(NSCLC)患者的II期臨牀研究獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。經審查,2022年1月17日受理的SKB264聯合治療晚期或轉移性非小細胞肺癌患者的II期臨牀研究,符合藥品註冊的有關要求,同意按照提交的方案開展臨牀試驗。

SKB264為科倫博泰擁有自主知識產權的靶向TROP2的人源化單克隆抗體、可酶促裂解的Linker連接着新型拓撲異構酶I抑制劑組合而成的抗體-偶聯藥物(TROP2-ADC),目前正在中美開展針對多個瘤種,包括非小細胞肺癌的II期臨牀試驗。

KL-A167為科倫博泰擁有自主知識產權的PD-L1單抗,於2021年11月首次遞交KLA167注射液的鼻咽癌適應症上市許可申請,當前處於審評審批中。

科倫博泰將按照國家藥品監督管理局簽發的臨牀試驗通知書的要求,組織實施注射用SKB264聯合治療的臨牀試驗。

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