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.
貝達藥業(300558.SZ):BPI-21668片用於治療晚期實體瘤獲批臨試
格隆匯 03-03 11:56

格隆匯3月3日丨貝達藥業(300558.SZ)宣佈,今日,公司收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》(通知書編號:2021LP00274、2021LP00275),公司申報的BPI-21668片用於治療晚期實體瘤的藥品臨牀試驗申請已獲得國家藥品監督管理局批准。

BPI-21668是一個由貝達藥業自主研發的擁有完全自主知識產權的新分子實體化合物,是一種新型強效、高選擇性的磷脂酰肌醇3-激酶α(Phosphatidylinositol3-kinase α, PI3Kα )口服小分子抑制劑,擬用於 PIK3CA(Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)基因突變的晚期實體瘤的治療。

截至該公吿披露日,全球僅有一款PI3Kα選擇性抑制劑Alpelisib(諾華開發)獲批用於攜帶PIK3CA突變的HR+/HER2-乳腺癌治療,中國區域內尚無PI3Kα選擇性抑制劑上市。BPI-21668屬於“境內外均未上市的創新藥”,其註冊分類為化學藥品1類。

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