Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) experienced a significant increase, rising nearly 7% in early trading, with a current price of 14.23 HKD and a trading volume of 9.34 million HKD, following the announcement of the acceptance of their new drug clinical trial application by the FDA for LAE118 [1] Group 1: Company Developments - Lai Kai Pharmaceutical announced that the FDA has accepted the Investigational New Drug (IND) application for LAE118 on January 14 [1] - LAE118 is a novel PI3Kα pan-mutant selective inhibitor developed by Lai Kai, aimed at treating patients with PIK3CA mutations in solid tumors [1] Group 2: Industry Context - PI3Kα mutations are commonly found in patients with breast cancer, colorectal cancer, lung cancer, endometrial cancer, and other cancers [1] - Currently approved PI3Kα inhibitors globally lack selectivity for mutant types, exhibiting strong activity against wild types, which leads to poor tolerability and a high likelihood of developing resistance [1]
来凯医药-B涨近7% LAE118新药临床试验申请获FDA受理