LAEKNA-B (02105): The US Food and Drug Administration has accepted the clinical trial application for the new drug LAE118.

LAEKNA-B (02105) announced that the Food and Drug Administration of the United States has accepted the new drug clinical trial application for LAE118. LAE118 is a novel PI3K pan-mutant selective inhibitor used for treating solid tumor patients with PIK3CA mutations. The company will closely collaborate with regulatory agencies to complete the relevant applications. With its successful and validated track record in clinical development and out-licensing of LAE002 (afuresertib), the company is committed to providing this precision treatment for cancer patients in need of new therapy options. LAE118 is a novel PI3K pan-mutant selective inhibitor. As a new therapy for solid tumors with PIK3CA mutations, the group is actively advancing this candidate drug into clinical studies.