健康元(600380.SH):妥布黴素吸入溶液獲得藥品註冊證書
格隆匯10月14日丨健康元(600380.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》。藥品名稱:妥布黴素吸入溶液。經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。
妥布黴素吸入溶液為公司研發的改良型新藥,適用於成人伴肺部銅綠假單胞菌感染的支氣管擴張症,控制感染和改善症狀,為全球首次上市的新適應症,具有明顯臨牀優勢。本品為國內首個獲批上市的吸入抗生素,獲得國家“重大新藥創制”科技重大專項支持。
本品首次提交臨牀試驗申請獲得受理時間為2017年1月,受理號為CXHL1700026,2017年9月獲得臨牀批件;提交上市許可申請獲得受理時間為2021年8月,受理號為CXHS2101036。
支氣管擴張症是一種不可逆轉的慢性氣道疾病,其主要症狀為慢性咳嗽、咳痰、咯血。銅綠假單胞菌感染支擴患者的肺功能下降速度更快,更易發生急性加重和住院治療,病死率更高,嚴重影響患者生活質量。本品在國內30多家中心開展的Ⅲ期臨牀研究結果顯示,妥布黴素吸入溶液治療伴肺部銅綠假單胞菌感染的支擴患者,可有效清除患者氣道內銅綠假單胞菌的數量,顯著改善支擴患者的生活質量,安全性和耐受性良好。本品成功上市,將可改變肺部伴肺部銅綠假單胞菌感染的支氣管擴張患者霧化吸入治療領域在國內外均無藥可用的現狀,具有明顯臨牀價值。
截至本公吿日,公司妥布黴素吸入溶液的累計研發投入約為人民幣6967.47萬元。
根據國家藥品監督管理局相關網站及鹹達數據庫顯示,截至目前,國內只有本公司取得該品種註冊批件,國內另有1家企業於2021年11月獲得臨牀批件。
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.