海南海藥(000566.SZ):氟非尼酮膠囊納入突破性治療品種名單
格隆匯2月13日丨海南海藥(000566.SZ)公佈,公司全資子公司海口市製藥廠有限公司與中南大學聯合申請的治療肝纖維化的創新藥氟非尼酮膠囊近日被國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)納入突破性治療品種名單。
肝纖維化是各種慢性肝臟疾病進展至肝硬化的共同通路和主要病理基礎,爲患病率高、危害巨大、預後不良的疾病,是一個全球性的衛生健康問題。各種慢性肝臟疾病(慢性病毒肝炎、慢性酒精性肝病、血吸蟲性肝病、血色病、卟啉症、酪氨酸代謝紊亂、肝豆狀核變性等代謝性疾病所致的肝臟損害、自身免疫性肝炎、化學毒物和藥物引起的中毒性肝炎等)均可進展爲肝纖維化,目前國內外尚缺少統一的大規模流行病學調査數據。根據原發病的不同,其早期的臨牀表現多種多樣。但晚期均表現爲肝硬化的臨牀表現。
非臨牀研究發現氟非尼酮具有明確的抗肝、腎纖維化作用,其抗纖維化的作用機制涉及抗炎症反應、抗氧化應激、抗細胞凋亡、抑制細胞的增殖與活化、促進ECM降解等多個方面。公司氟非尼酮膠囊已完成的Ⅰ期臨牀研究證明瞭其在人體的安全性和耐受性良好。Ⅱ期臨牀研究已完成期中分析,據獨立數據監查委員會(IDMC)的建議表明:該研究已達到方案設定的主要研究終點,可終止Ⅱ期臨牀試驗的受試者入組,並考慮開展後續的Ⅲ期臨牀試驗。
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.