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.
奧賽康(002755.SZ):哌柏西利膠囊獲得上市許可申請受理通知書
格隆匯 03-01 20:20

格隆匯 3 月 1日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)近日收到國家藥品監督管理局(“藥監局”)下發哌柏西利膠囊境內生產藥品註冊上市許可申請受理知書

哌柏西利是細胞週期蛋白依賴性激酶CDK4/6抑制劑,由輝瑞製藥公司研發。哌柏西利膠囊於2015年獲美國FDA加快審評途徑批准上市,隨後分別在歐盟、英國和日本上市。2018年,哌柏西利膠囊進口獲NMPA批准,用於激素受體(HR)陽性、人表皮生長因子受體2 (HER2)陰性的局部晚期或轉移性乳腺癌,應與化酶抑制劑聯合使用作為絕經後女性患者的初始內分泌治療。

乳腺癌是女性常見的惡性腫瘤之一,發病率位居女性惡性腫瘤首位,嚴重危害婦女的身心健康。內分泌治療因原發耐藥與繼發耐藥而使其有效性受到限制。CDK4/6抑制劑是逆轉內分泌治療耐藥的有效藥物,其與內分泌治療聯用現已納入晚期HR陽性乳腺惡性腫瘤治療指南。Cortellis數據庫顯示哌柏西利2020年全球銷售額為53.92億美元,PDB數據庫顯示2019年度中國樣本醫院銷售額達0.22億元。哌柏西利是全球首個獲准上市的CDK4/6抑制劑,可明顯延長晚期乳腺癌患者的無進展生存期,為晚期乳腺癌患者提供了新的治療選擇

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