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.
恆瑞醫藥(600276.SH):馬來酸吡咯替尼片獲批臨牀試驗
格隆匯 12-06 16:33

格隆匯12月6日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗,藥品名稱為馬來酸吡咯替尼片。

2019912日,公司向國家藥監局遞交本品臨牀試驗申請獲受理,具體為馬來酸吡咯替尼片治療曲妥珠單抗輔助治療後的HER2陽性早期或局部晚期乳腺癌的隨機、雙盲、安慰劑對照的多中心III期臨牀研究

經查詢,目前國外已上市用於乳腺癌治療的同類產品有Tykerb®lapatinib)和Nerlynx®neratinib)。Tykerb®GlaxoSmithKline公司開發,最早於20073月獲美國食品藥品監督管理局批准,規格為250mg片,國內已進口上市。Nerlynx®Puma Biotechnology,Inc.公司開發,20177美國食品藥品監督管理局批准,規格為40mg20189國家藥監局提交上市申請,目前狀態為在審評審批經查詢IMS數據庫,2018Tykerb®全球銷售額約為1.7億美元,中國銷售額約為1078萬美元;Nerlynx®全球銷售額約為1327萬美元。

截至目前,該產品項目已投入研發費用約為70763萬元人民幣。

根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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