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]

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 Technology Co., Ltd. marks a significant advancement in the treatment of KRAS G12C mutated non-small cell lung cancer (NSCLC) patients [1] Group 1 - The IND application was 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 combined use of ABSK043 and citric acid gorasetinib tablets was reached in March 2025 [1] - The study is an open-label Phase II clinical trial assessing the safety, tolerability, and efficacy of ABSK043 in combination with citric acid gorasetinib tablets for patients with locally advanced or metastatic NSCLC carrying the KRAS G12C mutation [1]