健康元(600380.SH):“馬來酸茚達特羅吸入粉霧劑”獲批臨牀試驗
格隆匯 8 月 11日丨健康元(600380.SH)發佈公告,近日,公司收到國家藥品監督管理局(以下簡稱:國家藥監局)簽發的《藥物臨牀試驗批准通知書》。現將相關情況公告如下:
一、藥品基本情況
藥品通用名稱:馬來酸茚達特羅吸入粉霧劑
英文名/拉丁名:IndacaterolMaleatePowderforInhalation
劑型:吸入粉霧劑
規格:150μg(以C24H28N2O3計)
申請事項:藥品註冊(境內生產)
註冊分類:化學藥品4類
上市許可持有人:健康元藥業集團股份有限公司
生產企業:深圳市海濱製藥有限公司
批准內容:本品已完成與原研品的以PK為終點的生物等效性研究,接受本品與參比製劑具有生物等效性的結論。需按照相關指導原則要求開展臨牀試驗。
二、藥品研發及相關情況
本品為本公司自主研發產品。本公司首次提交馬來酸茚達特羅吸入粉霧劑註冊獲得受理時間為2020年01月03日,受理號為CYHS2000011。本品活性成分茚達特羅為支氣管舒張劑,屬於新一代長效吸入β2受體激動劑,主要用於成人慢性阻塞性肺疾病(COPD)患者的維持治療。
截止本公告日,馬來酸茚達特羅吸入粉霧劑公司累計直接投入的研發費用約人民幣1,784.06萬元。
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.