中國生物製藥(01177.HK)：鹽酸安羅替尼膠囊聯合化療一線治療軟組織肉瘤適應症獲批上市
格隆匯6月30日丨中國生物製藥(01177.HK)公吿，集團開發的鹽酸安羅替尼膠囊聯合化療方案，已獲得中國國家藥品監督管理局批准，用於局部晚期或轉移性軟組織肉瘤患者的一線治療。這是安羅替尼在中國獲批的第九個適應症。此次獲批標誌着全球首個聯合化療的組合療法正式獲批用於晚期或轉移性軟組織肉瘤的一線治療。此前，安羅替尼單藥已被中國臨牀腫瘤學會(CSCO)指南推薦用於二線晚期或轉移性軟組織肉瘤治療，且為唯一I級推薦的靶向治療藥物。
2025年美國臨牀腫瘤學會(ASCO)年會上公佈了安羅替尼聯合化療用於不可切除的晚期或轉移性軟組織肉瘤一線治療的III期臨牀研究(NCT05121350)期中分析數據：截至2024年2月15日，該研究共完成272例患者隨機入組（試驗組135例，對照組137例），中位隨訪時間7.16個月，試驗組較對照組顯著延長中位無進展生存期(PFS)（8.6個月vs 3.0個月；HR=0.30, 95% CI 0.21-0.44, P<0.001），客觀緩解率(ORR)提升近6倍(17.8% vs 2.9%)，疾病控制率(DCR)顯著提高(79.3% vs 54.7%)。總生存期(OS)數據尚未成熟(HR=0.78, 95% CI 0.49-1.25)，但已顯示出獲益趨勢。預設的亞組分析（包括平滑肌肉瘤、滑膜肉瘤及其他病理亞型）均顯示試驗組獲益趨勢一致。該結果表明，安羅替尼聯合化療一線治療軟組織肉瘤展現出明確的抗腫瘤效果。
除軟組織肉瘤外，安羅替尼目前已獲批的適應症覆蓋多個癌腫領域，包括非小細胞肺癌、小細胞肺癌、甲狀腺髓樣癌、分化型甲狀腺癌、子宮內膜癌、腎細胞癌。此外，安羅替尼聯合貝莫蘇拜單抗用於治療腺泡軟組織肉瘤的適應症即將遞交上市申請。集團將大力推進創新產品的開發，充分挖掘產品潛力，力爭為更多患者提供更優的治療方案。
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 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.
