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.
康方生物(09926.HK):依達方®(依沃西注射液,PD-1/VEGF)獲得國家藥品監督管理局批准上市
格隆匯 05-24 12:29

格隆匯5月24日丨康方生物(09926.HK)宣佈,中國國家藥品監督管理局("NMPA")已批准公司自主研發的全球首創雙特異性抗體新藥依達方®( 依沃西注 射液,PD -1 / VEGF )的新藥上 市申請 ,適應症為聯合化療用於治療經表 皮生長因子受體("EGFR")酪氨酸激黴抑制劑("TKI")治療後進展的EGFR突變的局部晚期或轉移性非鱗狀非小細胞肺癌("nsq-NSCLC")。

本次依達方®獲得NMPA批准上市是基於AK112 -301 / HARMONi-A (CTR20213079),一項在中國開展的隨機、雙盲、多中心III期臨牀研究,研究的主要終點為無進展生存期(PFS),次要終點為總生存期(OS)。

肺癌是世界範圍內高發病率和高死亡率的常見惡性腫瘤。2020年世界新發肺癌病人數超220萬,中國新發病人數超過81萬,其中非小細胞肺癌(NSCLC)患者大約佔85%。EGFR突變是中國NSCLC患者最主要的突變類型,EGFR-TKI是其現行主要治療手段,而該患者人羣耐藥進展後存在着廣泛的未被滿足的治療需求。依達方®有望為EGFR-TKI治療後進展的局部晚期或轉移性nsq-NSCLC患者提供全新高效的治療方案。

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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
uSMART
Wealth Growth Made Easy
Open Account