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.
景峯醫藥(000908.SZ)子公司收到藥品一致性評價補充申請受理通知書
格隆匯 10-18 16:47

格隆匯 10 月 18日丨景峯醫藥(000908.SZ)發佈公告,近日,公司的子公司海南錦瑞製藥有限公司獲得國家藥品監督管理局下發的《受理通知書》,由海南錦瑞製藥有限公司提交的“注射用蘭索拉唑”一致性評價補充申請已獲正式受理。

注射用蘭索拉唑由日本武田藥品株式會社開發,1991年12月首次在歐洲上市,1992年12月在日本獲得批准上市。2004年5月,日本武田藥品工業株式會社開發的注射用蘭索拉唑獲得美國食品藥品監督管理局批准上市(該產品於2007年2月在美國退市)。目前注射用蘭索拉唑原研藥品尚未在國內上市。

注射用蘭索拉唑用於口服療法不適用的下列疾病:伴有出血的胃潰瘍、十二指腸潰瘍、急性應激性潰瘍、急性胃粘膜病變。蘭索拉唑屬於質子泵抑制劑。本藥分佈於胃粘膜壁細胞的酸性環境後,轉變為有活性的代謝物。這種代謝物與存在於酸生成部位的H+,K+-ATP酶的巰基結合,通過抑制H+,K+-ATP酶的活性而抑制酸分泌。

公告表示,注射用蘭索拉唑一致性評價補充申請的受理標誌着公司該產品的一致性評價工作已基本完成,進入了審評審批階段。公司將積極推進其後續相關工作,如順利通過一致性評價將享受國家關於通過一致性評價藥品品種的鼓勵和支持政策,提升其市場競爭力,對公司將產生積極的影響。

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