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.
復宏漢霖-B(02696.HK):HLX02注射用曲妥珠單抗新增60mg規格補充申請(sNDA)獲NMPA受理
格隆匯 10-19 18:50

格隆匯 10 月 19日丨復宏漢霖-B(02696.HK)發佈公告,今日,公司全資子公司上海復宏漢霖生物製藥有限公司收到國家藥品監督管理局(“NMPA”)核准簽發的HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優®;歐盟商品名:Zercepac®)補充申請(sNDA)《受理通知書》(受理號:CYSB2000228國),HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優®;歐盟商品名:Zercepac®)就新增60mg/瓶規格遞交的補充申請(sNDA)獲NMPA受理。

公司已根據《已上市生物製品藥學變更研究技術指導原則》(徵求意見)等技術指導原則的要求對新增60mg/瓶規格進行了充分的技術研究,研究結果表明60mg/瓶規格質量與已獲批的150mg/瓶質量可比。

本次HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優®;歐盟商品名:Zercepac®)新增60mg/瓶規格的補充申請(sNDA)如順利獲批,未來患者可以通過配合使用150mg/瓶和60mg/瓶規格的HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優®;歐盟商品名:Zercepac®)來實現更經濟的用藥。

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