麗珠醫藥(01513.HK)附屬收到注射用重組人絨促性素藥品註冊證書
格隆匯4月15日丨麗珠醫藥(01513.HK)發佈公吿,近日,公司控股附屬公司珠海市麗珠單抗生物技術有限公司收到國家藥品監督管理局簽發的《藥品註冊證書》。
該藥品通用名稱:注射用重組人絨促性素。注射用重組人絨促性素是麗珠單抗按照生物類似藥研發的治療用生物製品。首次提交注射用重組人絨促性素臨牀試驗申請獲得受理的時間為2014年12月(受理號:CXSL1400155粵),獲得臨牀批件的時間為2016年9月,申報生產的受理時間為2019年1月。
本品適用於:1、接受輔助生殖技術如體外受精(IVF)之前進行超促排卵的女性:注射本品用於刺激卵泡生長後觸發卵泡的最終成熟和黃體化。2、無排卵或稀發排卵女性:注射本品用於刺激卵泡生長後觸發排卵及黃體化。截至本公吿日,注射用重組人絨促性素累計研發投入約為人民幣11,589.20萬元。
人絨促性素根據其製備來源分為尿源人絨促性素(u-hCG)和重組人絨促性素(r-hCG)。目前,全球僅有默克雪蘭諾的重組人絨促性素藥物上市銷售,商品名:艾澤(英文Ovidrel),該產品於2005年在中國獲批進口。
根據IQVIA抽樣統計估測數據,國內人絨促性素2020年終端銷售金額(包括尿源與重組)約為人民幣13,840.99萬元,國內重組人絨促性素2020年終端銷售金額約為人民幣5,195.79萬元。根據CDE審評中心網站顯示,截至本公吿日,國內僅麗珠單抗取得該品種生產批件,未見其他廠家註冊申報臨牀及生產。
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.