恆瑞醫藥(600276.SH):SHR8008膠囊的藥品上市許可申請獲受理
格隆匯1月14日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局下發的《受理通知書》,公司提交的SHR8008膠囊的藥品上市許可申請獲藥監局受理。擬定適應症(或功能主治):本品用於治療急性外陰陰道假絲酵母菌病。
藥品的臨牀試驗情況:2021年11月,SHR8008膠囊治療急性外陰陰道假絲酵母菌病的有效性與安全性的隨機、雙盲雙模擬、氟康唑平行對照、多中心Ⅲ期臨牀研究(方案編號:SHR8008-302)主要研究終點結果達到方案預設的優效標準。SHR8008-302研究由北京清華長庚醫院廖秦平教授擔任主要研究者,全國25家中心共同參與,共入組322例急性外陰陰道假絲酵母菌病受試者。主要研究終點是第28天訪視時急性外陰陰道假絲酵母菌病發作痊癒(定義為急性外陰陰道假絲酵母菌病症狀體。
SHR8008是一種新型口服唑類抗真菌藥物,可高度特異性抑制真菌CYP51酶,在國外已經完成1項針對急性外陰陰道假絲酵母菌病的臨牀Ⅱ期研究、1項針對複發性外陰陰道假絲酵母菌病的臨牀Ⅱ期研究和3項針對複發性外陰陰道假絲酵母菌病的臨牀Ⅲ期研究。國內外有氟康唑、伊曲康唑、伏立康唑、盧力康唑、艾沙康唑等多種同類產品獲批上市。
氟康唑由輝瑞公司開發,1990年在美國獲批上市;伊曲康唑由JANSSEN公司開發,1992年在美國獲批上市;伏立康唑由輝瑞公司開發,2002年在美國獲批上市;盧力康唑由Pola公司開發,2005年在日本獲批上市;艾沙康唑由ASTELLAS公司開發,2015年在美國獲批上市。以上五種藥物均已在國內獲批上市。經查詢,2020年氟康唑、伊曲康唑、伏立康唑、盧力康唑和艾沙康唑全球銷售額合計約22.31億美元。截至目前,SHR8008相關項目累計已投入研發費用約9124萬元。
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.