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.
藥明巨諾-B(02126.HK):倍諾達®用於二線治療大B細胞淋巴瘤的關鍵性臨牀試驗申請獲批
格隆匯 03-31 12:25

格隆匯3月31日丨藥明巨諾-B(02126.HK)宣佈,其靶向CD19的自體嵌合抗原受體T("CAR-T")細胞免疫治療產品倍諾達®(瑞基奧侖賽注射液)用於二線治療大B細胞淋巴瘤("LBCL")的關鍵性臨牀試驗申請已獲得中國藥監局的默示許可。

B細胞淋巴瘤是惡性B細胞單克隆擴增的一組異質性腫瘤,約佔非霍奇金淋巴 瘤("NHL")的85%。LBCL是B細 胞NHL中最常見的類型,在中國約佔35%至50%。雖然標準治療("R-CHOP")方案可以使50%以上的患者治癒,但仍有30%至40%LBCL患者接受一線R-CHOP方案治療後會出現原發性難治或復發,而該部分患者很難從常規化療方案中獲益。根據既往研究資料,標準一線治療後未達完全緩解("CR")或CR不足1年的患者,採用二線標準治療後總緩解率為29%,中位無進展生存時間("PFS")僅為3個月,中位總生存時間("OS")僅為10個月。因此,臨牀上迫切需要開發出新的治療方式,使標準一線治療後復發或難治性大B細胞淋巴瘤("r/r LBCL")患者獲益。

此次獲批的研究是一項在中國開展的多中心、隨機對照、開放性III期臨牀研究,旨在已使用一綫藥物(蒽環類藥物和利妥昔單抗或其他CD20靶向藥)治療之後未達CR,或CR後12個月內復發的r/r LBCL成年受試者中,評估倍諾達®的有效性和安全性。符合條件的受試者,將按1:1的比例隨機分配至對照組或試驗組,進入對照組的受試者將接受標準二線治療,進入試驗組的受試者將接受倍諾達®100×10 CAR-T細胞治療。主要研究終點為獨立評審委員會評估的無事件生存時間,次要研究終點包括完全緩解率、PFS、OS、緩解持續時間、藥代動力學和安全性等。

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