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.
健康元(600380.SH):阿地溴銨吸入粉霧劑獲批開展慢性阻塞性肺疾病的臨牀試驗
格隆匯 06-20 17:04

格隆匯6月20日丨健康元(600380.SH)公佈,近日,公司收到國家藥品監督管理局簽發的關於阿地溴銨吸入粉霧劑藥物臨牀試驗批准通知書》。

審批結論根據《中華人民共和國藥品管理法》及有關規定,經審查,阿地溴銨吸入粉霧劑符合藥品註冊的有關要求,同意本品開展慢性阻塞性肺疾病(COPD)的臨牀試驗。

阿地溴銨吸入粉霧劑為公司自主研發產品並獲得國家科技重大專項項目支持。公司首次提交本品註冊獲得受理時間為202141,受理號為CXHL2100218

阿地溴銨是一種新型的長效吸入性抗膽鹼能藥物(LAMA)本品為支氣管擴張劑,適用於慢性阻塞性肺疾病(COPD)的維持治療。本品開發劑型為吸入粉霧劑,具有穩定好,便於攜帶,使用方便等優勢,可提高患者用藥依從性。

截至公吿日,公司累計直接投入阿地溴銨吸入粉霧劑的研發費用約人民1455.64萬元

阿地溴銨吸入粉霧劑2.2類改良型新藥,國內已有的LAMA吸入製劑還包括噻託溴銨粉霧劑噻託溴銨噴霧劑及格隆溴銨粉霧劑等產品根據IQVIA抽樣統計估測數據,國內LAMA相關製劑產品2020年度終端銷售金額約為人民幣9.35億元其中噻託溴銨粉霧劑約為人民幣8.03億元,噻託溴銨噴霧劑約人民幣1.32億元,其他產品暫無銷售數據根據國家藥品監管理局藥品審評中心網站及鹹達數據庫顯示,截至目前,國內共有2(含公司)獲批臨牀試驗,暫無廠家取得生產批件。

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