来凯医药-B(02105)：美国食品药品监督管理局受理LAE118新药临床试验申请

Core Viewpoint - The company, 来凯医药-B (02105), has announced that the U.S. Food and Drug Administration (FDA) has accepted the clinical trial application for LAE118, a novel PI3Kα pan-mutant selective inhibitor aimed at treating patients with PIK3CA-mutant solid tumors [1] Group 1 - LAE118 is a new type of PI3Kα pan-mutant selective inhibitor [1] - The company is committed to collaborating closely with regulatory authorities to complete the relevant application [1] - The company aims to provide this precision treatment for cancer patients in need of new therapeutic options, leveraging its successful track record in clinical development and licensing of LAE002 (afuresertib) [1] Group 2 - The candidate drug LAE118 is actively being advanced into clinical research as a novel therapy for PIK3CA-mutant solid tumors [1]