復星醫藥(02196.HK):注射用曲妥珠單抗新增“60mg/瓶”規格獲國家藥監局藥品註冊補充申請審評受理
格隆匯10月19日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復宏漢霖生物製藥有限公司(以下簡稱“漢霖製藥”)的注射用曲妥珠單抗(即注射用重組抗HER2人源化單克隆抗體,商品名:漢曲優;以下簡稱“該新藥”)新增“60mg/瓶”規格獲國家藥品監督管理局(以下簡稱“國家藥監局”)藥品註冊補充申請審評受理。
該新藥為集團(即本公司及控股子公司/單位,下同)自主研發的單克隆抗體生物類似藥,主要用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌及HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療等。
2020年8月,漢霖製藥收到國家藥監局頒發的關於注射用曲妥珠單抗(規格:150mg/瓶)用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌、HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療的《藥品註冊證書》。本次向國家藥監局提出相關補充申請,主要為新增該新藥“60mg/瓶”規格,以擴容臨牀使用的選擇。
截至公告日,於中國境內(不包括港澳台地區,下同)上市的曲妥珠單抗為上海羅氏製藥有限公司的赫賽汀、漢霖製藥的漢曲優。根據IQVIACHPA資料(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2019年,曲妥珠單抗於中國境內的銷售額約為人民幣45.77億元。
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.