復宏漢霖(02696.HK):斯魯利單抗注射液(重組抗PD-1人源化單克隆抗體注射液)聯合化療用於廣泛期小細胞肺癌(ES-SCLC)治療的3期臨牀研究達到主要研究終點
格隆匯12月7日丨復宏漢霖(02696.HK)公吿,近日,公司自主開發的斯魯利單抗注射液(重組抗PD-1人源化單克隆抗體注射液)或安慰劑聯合化療(卡鉑-依託泊苷)在既往未接受過治療的廣泛期小細胞肺癌患者中開展的3期 HLX 10-005-SCL C301研究在計劃的期中分析中,經獨立數據監察委員會評估達到了總生存期(OS)的主要研究終點。
HLX10-005-SCLC301研究為一項比較斯魯利單抗注射液聯合化療(卡鉑-依託泊苷)及安慰劑聯合化療(卡鉑-依託泊苷)在既往未接受過治療的ES-SCLC患者中的隨機、雙盲、國際多中心3期臨牀研究,該研究主要目的是在既往未接受過治療的ES-SCLC患者中研究斯魯利單抗聯合化療的有效性和安全性。基於IDMC進行的預設期中分析結果顯示,斯魯利單抗聯合化療對比化療顯示出明顯的總生存期(OS)改善,達到預設的優效性標準,且安全性良好,未發現新的安全性信號。
斯魯利單抗注射液為公司自主開發的創新型抗PD-1單抗,計劃用於多種實體瘤治療,目前就1項單藥及以其為核心的8項聯合療法在全球多個國家和地區同步開展臨牀試驗。
2021年4月,斯魯利單抗注射液用於經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型實體瘤治療的上市註冊申請(NDA)獲國家藥品監督管理局藥品審評中心受理並正式納入優先審評審批程序。2021年9月,斯魯利單抗注射液聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌的上市註冊申請(NDA)獲NMPA受理。
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.