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.
華東醫藥(000963.SZ):1類新藥IMGN853美國關鍵性單臂臨牀試驗達到主要研究終點
格隆匯 12-01 08:14

格隆匯12月1日丨華東醫藥(000963.SZ)公佈,2021年11月30日,公司全資子公司杭州中美華東製藥有限公司美國合作方ImmunoGen對外宣佈,其組織開展的用於治療卵巢癌的生物製品1類新藥IMGN853(Mirvetuximab Soravtansine)美國關鍵性單臂臨牀試驗(簡稱“SORAYA試驗”)達到主要研究終點,確認的客觀緩解率為32.4%,中位緩解持續時間為5.9個月,臨牀試驗結果顯示其具備良好的耐受性。ImmunoGen預計2022年第一季度在美國遞交IMGN853的生物製品許可申請(BLA)。

抗腫瘤藥物為公司核心新藥研發領域,IMGN853為全球首個FRα靶點ADC藥物,也是公司腫瘤創新藥管線的重點在研產品。此次美國臨牀試驗的積極結果是該款新藥研發進程中的重要里程碑,有助於推動其美國獲批上市進程,對其在中國獲批上市也構成積極影響。公司將繼續全力開展這款產品在中國的臨牀開發及註冊工作,推動其儘早造福中國卵巢癌患者。

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