Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, citric acid giredestrant, for treating KRAS G12C mutated non-small cell lung cancer (NSCLC) patients [1] Group 1 - The clinical study is an open-label Phase II trial assessing the safety, tolerability, and efficacy of ABSK043 combined with citric acid giredestrant in patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - The collaboration agreement between Heyu Biopharmaceutical and Ailis was established in March 2025 for the combined treatment of ABSK043 and citric acid giredestrant [1] - Previous disclosures indicated another collaboration exploring the combination of ABSK043 with Ailis's developed Vemurafenib for treating advanced NSCLC, with the first patient dosing expected to be completed by December 2024 [1] Group 2 - Updated Phase I study results show that ABSK043 as a monotherapy has demonstrated good safety and impressive anti-tumor activity, particularly in patients with high PD-L1 expression and those with EGFR or KRAS mutations [1]
和誉-B: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