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中國生物製藥：自願公告 - KRAS G12C抑制劑「GARSORASIB（D-1553片）」II期臨床研究數據公佈

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - PRESENTATION OF THE PHASE II CLINICAL STUDY DATA ON KRAS G12C INHIBITOR "GARSORASIB TABLET (D-1553)"

香港交易所 ·  Apr 11 06:04
Summary by Futu AI
中國生物製藥有限公司宣佈，其聯合開發的KRAS G12C抑制劑「garsorasib（D-1553片）」在2024年美國癌症協會年會（AACR）公佈了II期臨床試驗的最新成果。該研究針對KRAS G12C突變的非小細胞肺癌（NSCLC）患者，顯示出garsorasib的客觀緩解率（ORR）為50%，疾病控制率（DCR）為89%，中位緩解持續時間（DOR）為12.8個月，中位無進展生存期（PFS）為7.6個月。研究為開放標籤、多中心、單臂II期研究，截至2023年11月17日，共有123例患者入組。研究結果顯示garsorasib具有良好的耐受性和可控性，對於醫療需求尚未得到滿足的患者群體，有望成為一種有效的治療選擇。D-1553是國內首個自主研發並進入臨床試驗階段的KRAS G12C抑制劑，並已被國家藥監局藥品審評中心（CDE）納入突破性治療品種。2023年12月，D-1553的新藥上市申請獲得受理，並於2024年1月被納入優先審評審批程序。
中國生物製藥有限公司宣佈，其聯合開發的KRAS G12C抑制劑「garsorasib（D-1553片）」在2024年美國癌症協會年會（AACR）公佈了II期臨床試驗的最新成果。該研究針對KRAS G12C突變的非小細胞肺癌（NSCLC）患者，顯示出garsorasib的客觀緩解率（ORR）為50%，疾病控制率（DCR）為89%，中位緩解持續時間（DOR）為12.8個月，中位無進展生存期（PFS）為7.6個月。研究為開放標籤、多中心、單臂II期研究，截至2023年11月17日，共有123例患者入組。研究結果顯示garsorasib具有良好的耐受性和可控性，對於醫療需求尚未得到滿足的患者群體，有望成為一種有效的治療選擇。D-1553是國內首個自主研發並進入臨床試驗階段的KRAS G12C抑制劑，並已被國家藥監局藥品審評中心（CDE）納入突破性治療品種。2023年12月，D-1553的新藥上市申請獲得受理，並於2024年1月被納入優先審評審批程序。
China Biopharmaceuticals Limited announced the latest results of a Phase II clinical trial of its co-developed KRAS G12C inhibitor “garsorasib (D-1553 tablets)” at the 2024 American Cancer Society Annual Meeting (AACR). The study in non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations showed that garsorasib had an objective alleviation rate (ORR) of 50%, a disease control rate (DCR) of 89%, a median duration of alleviation (DOR) of 12.8 months, and a median progression-free survival (PFS) of 7.6 months. The study was an open label, multicenter, single-arm Phase II study. 123 patients were enrolled as of 17 November 2023. Research results show that garsorasib has good tolerability and controllability and is expected to be an effective treatment option for patient populations whose medical needs have...Show More
China Biopharmaceuticals Limited announced the latest results of a Phase II clinical trial of its co-developed KRAS G12C inhibitor “garsorasib (D-1553 tablets)” at the 2024 American Cancer Society Annual Meeting (AACR). The study in non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations showed that garsorasib had an objective alleviation rate (ORR) of 50%, a disease control rate (DCR) of 89%, a median duration of alleviation (DOR) of 12.8 months, and a median progression-free survival (PFS) of 7.6 months. The study was an open label, multicenter, single-arm Phase II study. 123 patients were enrolled as of 17 November 2023. Research results show that garsorasib has good tolerability and controllability and is expected to be an effective treatment option for patient populations whose medical needs have not yet been met. D-1553 is the first KRAS G12C inhibitor to be independently developed and entered into the clinical trial phase in the country and has been included in the breakthrough therapeutic strain by the National Drug Administration's Center for Drug Review (CDE). In December 2023, D-1553's application to market a new drug was accepted and included in the priority review process in January 2024.

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