信達生物(01801.HK)：NMPA批准達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗注射液)用於治療一線肝癌
格隆匯6月28日丨信達生物(01801.HK)發佈公吿，國家藥品監督管理局(“NMPA”)已正式批准創新PD-1抑制劑達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗注射液)用於既往未接受過系統治療的不可切除或轉移性肝細胞癌的一線治療。這是全球首個獲批用於肝癌患者一線治療的PD-1免疫聯合療法。
根據披露，這是達伯舒®(信迪利單抗注射液)獲批的第四項適應症，也是達攸同®(貝伐珠單抗注射液)獲批的第四項適應症。達伯舒®(信迪利單抗注射液)2018年12月獲得NMPA批准用於治療復發或難治性經典型霍奇金淋巴瘤、2021年2月獲得NMPA批准聯合培美曲塞和鉑類用於晚期非鱗狀非小細胞肺癌(NSCLC)的一線治療及2021年6月獲得NMPA批准聯合吉西他濱和鉑類化療用於晚期鱗狀NSCLC的一線治療。此前達攸同®(貝伐珠單抗注射液)已獲NMPA批准包括晚期非小細胞肺癌、轉移性結直腸癌和成人複發性膠質母細胞瘤在內的三個適應症。
此次適應症獲批是基於一項隨機、開放、III期對照臨牀研究(ORIENT-32)——達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗注射液)用於不可切除或轉移性肝細胞癌的一線治療。基於期中分析結果的獨立數據委員會(iDMC)審核，達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗注射液)對比索拉非尼單藥治療，顯着延長了總生存期(OS)和無進展生存期(PFS)，達到預設的優效性標準。聯合治療方案安全性數據與既往報道一致，無新的安全性信號。
肝癌是中國發病率第四位、死亡率第二位的惡性腫瘤，五年生存率僅10%左右。肝癌對化療藥物不敏感，靶向藥物單藥治療療效有限。晚期肝癌依舊存在着巨大的未滿足的臨牀需求，免疫治療的出現改寫了肝癌的治療譜。公司很高興達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗注射液)新適應症獲批，為廣大肝癌患者提供了新的治療選擇，將使得更多患者獲益。
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.
