Core Viewpoint - The company 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: Drug Development - LAE118 is a new type of PI3Kα pan-mutant selective inhibitor [1] - The company is actively advancing this candidate drug into clinical research as a novel therapy for PIK3CA-mutant solid tumors [1] - The company aims to provide precision treatment options for cancer patients in need of new therapeutic solutions [1] Group 2: Regulatory Collaboration - The company will work closely with regulatory authorities to complete the relevant application [1] - The company has a proven track record in clinical development and licensing, particularly with LAE002 (afuresertib) [1]
来凯医药-B：美国食品药品监督管理局受理LAE118新药临床试验申请