健康元(600380.SH):子公司“重組人促卵泡激素注射液”獲得藥物臨牀試驗批准通知書
格隆匯9月10日丨健康元(600380.SH)公佈,近日,公司控股子公司麗珠醫藥集團股份有限公司(“麗珠集團”)控股子公司珠海市麗珠單抗生物技術有限公司(“麗珠單抗”,公司直接和間接持有的麗珠單抗權益為55.90%)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。
重組人促卵泡激素注射液(“該品”)歷經2年研發,是麗珠單抗自主開發的促性腺激素類輔助生殖藥物,首次提交臨牀試驗申請獲得受理的時間為2021年7月2日(受理號:CXSL2101170)。
該品是默克公司果納芬®(Gonal-f®)的生物類似藥,適應症為:(1)無排卵(包括多囊卵巢綜合徵[PCOS])且對枸櫞酸克羅米酚治療無反應的婦女。(2)在輔助生育技術(ART)如體外受精(IVF)、配子輸卵管內轉移(GIFT)和合子輸卵管內移植(ZIFT)中進行超排卵的婦女,使用該品可刺激多卵泡發育。(3)嚴重缺乏促黃體激素(LH)和促卵泡激素(FSH)的患者,即內源性的血清LH水平<1.2IU/L的患者。推薦LH與FSH聯合使用以刺激卵泡的發育。
該產品為每支預裝0.75mL注射液的預充注射筆,無附帶溶劑和給藥裝置,給藥途徑為皮下注射。
截至公吿日,重組人促卵泡激素注射液累計直接投入的研發費用約為人民幣2968.81萬元。
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.