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.
復星醫藥(02196.HK):蘆沃美替尼片的上市註冊申請獲國家藥監局批准
格隆匯 05-29 19:12

格隆匯5月29日丨復星醫藥(02196.HK)發佈公吿,近日,公司控股子公司上海復星醫藥產業發展有限公司就蘆沃美替尼片(商品名:復邁寧;項目代號:FCN-159;以下簡稱“該新藥”)的上市註冊申請獲國家藥品監督管理局批准,本次獲批適應症包括用於治療(1)朗格漢斯細胞組織細胞增生症(LCH)和組織細胞腫瘤成人患者;(2)2歲及2歲以上伴有症狀、無法手術的叢狀神經纖維瘤(PN)的Ⅰ型神經纖維瘤病(NF1)兒童及青少年患者。

該新藥為集團自主研發的創新型小分子化學藥物,為MEK1/2選擇性抑制劑。

除本次獲批的適應症外,截至本公吿日期(即2025年5月29日),該新藥用於治療成人Ⅰ型神經纖維瘤病於中國境內(不包括港澳台地區,下同)處於Ⅲ期臨牀試驗階段,該新藥用於低級別腦膠質瘤、顱外動靜脈畸形、兒童朗格漢斯細胞組織細胞增生症的治療於中國境內均處於Ⅱ期臨牀試驗階段;其中,該新藥用於無法手術或術後殘留/復發的NF1相關的叢狀神經纖維瘤成人患者、兒童朗格漢斯組織細胞增生症兩項適應症均已被國家藥監局藥品審評中心納入突破性治療藥物程序。

截至2025年4月,集團現階段針對該新藥的累計研發投入約為人民幣5.98億元(未經審計)。根據IQVIA MIDAS?最新數據1,2024年,MEK1/2選擇性抑制劑於全球範圍的銷售額約為20.68億美元。

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.
uSMART
Wealth Growth Made Easy
Open Account