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):注射用右蘭索拉唑新藥上市申請獲受理
格隆匯 01-11 20:31

格隆匯 1 月 11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”)下發注射用右蘭索拉唑新藥上市申請受理通知書

右蘭索拉唑屬於質子泵抑制劑,為蘭索拉唑的R-異構體。右蘭索拉唑腸溶膠囊(30mg60mg)由武田製藥(Takeda Pharma.)研究開發,於2009年首先在美國上市,用於治療各種程度的糜爛性食管炎、非糜爛性反流性食管炎及相關症狀的維持治療,目前全球尚無右蘭索拉唑注射劑上市。我公司根據其藥理作用特點,按2類新藥開發了注射用右蘭索拉唑(製劑規格:15mg),擬用於治療口服療法不適用的急性上消化道出血等疾病,20162月獲得注射用右蘭索拉唑的臨牀批件(臨牀批件號:2016L02614),現已完成藥學、非臨牀及臨牀相關研究,提交了生產註冊申請,並獲得CDE正式受理(受理號:CXHS2100001國)

右蘭索拉唑通過抑制胃壁細胞酸生成部位的H+-K+-ATP酶的活性而抑制胃酸分泌。大鼠胃酸分泌及胃潰瘍等模型的藥效研究結果顯示,右蘭索拉唑的體內活性是左蘭索拉唑的510倍,提示右蘭索拉唑是蘭索拉唑的主要活性成分。與左旋體和消旋體相比,右蘭索拉唑具有更好的藥代動力學和藥效學特性,從而發揮更強、更持久的抑酸作用。右蘭索拉唑腸溶膠囊2019年全球銷售額為6.34美元,目前國際上尚無右蘭索拉唑注射劑上市銷售;其消旋體蘭索拉唑膠囊和注射劑已經中國上市多年,PDB數據庫顯示2019年中國樣本醫院注射用蘭索拉唑的銷售8.5億元,市場潛力大。我公司開發的注射用右蘭索拉唑若成功獲批,將為臨牀醫生、患者提供更多的用藥選擇

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