歌禮制藥-B(01672.HK): FXR激動劑ASC42治療原發性膽汁性膽管炎臨試申請獲國家藥監局受理
格隆匯9月6日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬公司甘萊製藥有限公司的ASC42治療原發性膽汁性膽管炎(PBC)患者的臨牀試驗申請已獲中國國家藥監局受理。
ASC42是一款由公司完全自主研發、有望成為同類最佳的新型高效選擇性非甾類FXR激動劑。2021年6月16日,公司宣佈甘萊的ASC42在美國I期臨牀試驗中取得良好的安全性和藥效學生物標誌物頂線數據。數據顯示,在人體有效劑量 15mg、每日一次、為期14天的治療過程中,未觀察到瘙癢症狀且FXR靶向激活的生物標誌物成纖維細胞生長因子19 (FGF19)在給藥第14天時的增幅高達1,632%。
根據《原發性膽汁性膽管炎診療規範(2021)》 ,PBC是一種慢性進展性自身免疫性膽汁淤積性疾病,常發展為肝纖維化及肝硬化,直至需進行肝移植或導致死亡。2010年PBC流行病學研究顯示,PBC的中國患病率為49.2/10萬人,在40歲以上的女性人羣中患病率高達155.8/10萬人,由此推算中國的PBC患病總人數為 656,000,其中40歲以上女性的患病人數為440,000。熊去氧膽酸(UDCA)是中國唯一批准的具有延緩疾病進展作用的藥物。然而,約40%的PBC患者對UDCA應答不足或不耐受。因此,研發用於治療PBC患者的新藥如ASC42,存在高度未被滿足的醫療需求。
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.