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.
李氏大藥廠(00950.HK)獲國家藥監局批授開展Intrarosa多中心、隨機、雙盲、並行組別III期臨牀試驗
格隆匯 01-15 20:26

格隆匯 1 月 15日丨李氏大藥廠(00950.HK)公吿,於2021年1月5日,公司全資附屬公司兆科藥業(合肥)有限公司已獲中國國家藥品監督管理局批授開展Intrarosa的多中心、隨機、雙盲、並行組別的III期臨牀試驗的臨牀試驗批准。

Intrarosa為Endoceutics,Inc.特許授權的產品,用於治療外陰陰道萎縮。此關鍵的III期研究預期於2021年第二季開始招募患者。

Intrarosa是唯一一種獲美國食物及藥物管理局(FDA)認證供日常局部使用的不含雌激素類固醇,用於治療因更年期而出現的中等至嚴重程度的性交疼痛(性交時產生的疼痛,為一種外陰陰道萎縮徵狀)。Intrarosa的產品資料並無任何包裝(安全)警吿,有別於其他獲FDA認證用於治療外陰陰道萎縮的藥物,全部均印有包裝警吿。

Intrarosa含有普拉雄酮(又名脱氫表雄酮(DHEA))。普拉雄酮為一種非活性內源性類固醇,會內部轉化為雄激素及雌激素,幫助修復陰道纖維組織,從表層和副基底細胞的百分比以及酸礆值改善可見一斑。

Endoceutics為一間加拿大私營藥業公司,從事婦女健康及激素敏感癌症的預防及治療。於Intrarosa在2016年11月獲美國FDA認證用於治療因更年期而出現的中等至嚴重程度的性交疼痛(一種外陰陰道萎縮徵狀),以及在2018年1月及2019年11月分別獲歐盟藥物管理機構及加拿大衞生部認證用於治療更年期後女性的外陰陰道萎縮後,Endoceutics現時致力於協助合作伙伴將此項創新產品作全球商業化,推進產品管線。

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