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和誉-B(02256):和誉医药的口服PD-L1抑制剂ABSK043与艾力斯的 KRAS G12C抑制剂枸橼酸戈来雷塞片联合用药治疗NSCLC的 IND申请获CDE批准
智通财经网·2025-08-20 11:31

Core Viewpoint - The approval of the IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor from Shanghai Elysium Pharmaceutical for treating KRAS G12C mutated non-small cell lung cancer (NSCLC) patients marks a significant advancement in cancer treatment [1] Group 1 - The IND application for the combination therapy has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China [1] - The collaboration agreement between the company and Elysium regarding the use of ABSK043 with the citric acid gorasetinib tablets is set to be effective from March 2025 [1] - The approved study is an open-label Phase II clinical trial assessing the safety, tolerability, and efficacy of ABSK043 in combination with citric acid gorasetinib for patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1]