HeYu Pharmaceutical: The IND application for the oral small molecule KRAS G12D inhibitor ABSK141 has been approved by the FDA.

Hony Pharma announced that its subsidiary, Shanghai Hony Biopharmaceutical Technology Co., Ltd., has received approval from the U.S. Food and Drug Administration for the clinical trial application of the oral small molecule KRAS G12D inhibitor ABSK141. ABSK141 is an oral, highly active, and highly selective small molecule KRAS G12D inhibitor for the treatment of late-stage solid tumor patients with the KRAS G12D mutation. The approved study is an open-label phase I/II clinical trial aimed at evaluating the safety, tolerability, efficacy, and pharmacokinetics of ABSK141 in late-stage solid tumor patients carrying the KRAS G12D mutation.