LAE Pharma Announces FDA Acceptance of IND Application for Novel PI3Kα Inhibitor LAE118, Shares Surge Nearly 9%

　　【Pharmaceutical Network Medical Stock Market】In the afternoon of January 16, Laekna Therapeutics once rose nearly 9%. According to data statistics, as of 15:12 on January 16, Laekna Therapeutics increased by 8.76%, trading at HK$14.65, with a trading volume of 71,000 shares and a turnover of HK$1.0317 million. At the close of trading today, the company rose by 7.65%, closing at HK$14.50, with a total market value of HK$6.474 billion.
 

In terms of news, Laekna Therapeutics announced on the Hong Kong Stock Exchange on the morning of January 14 that the U.S. Food and Drug Administration (FDA) has accepted the clinical trial application for the new drug LAE118.
 

Data show that LAE118 is a novel PI3Kα pan-mutant selective inhibitor for the treatment of patients with PIK3CA-mutant solid tumors. As a new therapy targeting PIK3CA-mutant solid tumors, the group is actively advancing this candidate drug into clinical research.
 

It is reported that tumor drugs are one of the core fields of Laekna Therapeutics. From 2017 to 2020, Laekna Therapeutics successively introduced LAE001, LAE002, LAE003, and LAE005 from Novartis. Among them, LAE002 and LAE001 are the fastest progressing products in the company's R&D pipeline.
 

Data shows that LAE002 is a potent AKT inhibitor capable of simultaneously inhibiting the three subtypes AKT1, AKT2, and AKT3. It is one of only two AKT inhibitors globally in late-stage clinical development for breast cancer and prostate cancer. In the HR+/HER2- breast cancer indication area, its global R&D progress ranks just behind Capivasertib from multinational pharmaceutical company AstraZeneca. Industry experts predict that the peak sales of LAE002 in the Chinese market could reach 2 billion yuan.
 

Laekna Therapeutics has laid out five indications for LAE002. Currently, the HR+/HER2- breast cancer indication is progressing rapidly, with a Phase III clinical trial (AFFIRM-205) initiated in 2024. The goal is to submit a new drug application to the Center for Drug Evaluation of the China National Medical Products Administration by the first half of 2026.
 

Notably, in November 2025, Laekna Therapeutics announced an exclusive licensing agreement with Qilu Pharmaceutical. The latter has been granted an exclusive license to research, develop, and commercialize LAE002 (afuresertib) in the China region (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan, China). The total value of the agreement can reach up to 2.045 billion yuan.
 

However, from the current perspective, Laekna Therapeutics also faces dual pressures of continuous losses and industry competition. According to data statistics, for the years 2023, 2024, and the first half of 2025, Laekna Therapeutics' net profits were -369 million yuan, -254 million yuan, and -130 million yuan respectively, with cumulative losses exceeding 700 million yuan; during the same periods, its R&D expenses were 230 million yuan, 215 million yuan, and 105 million yuan respectively.
 

Despite the重重 challenges, the pipeline potential and strategic layout of Laekna Therapeutics may still possess long-term value. The clinical advancement of LAE118 will enrich the company’s pipeline梯队, and if the commercialization process of LAE002 can be successfully implemented as scheduled, it is expected to become a turning point for the company’s performance. The collaboration with Qilu Pharmaceutical not only alleviates financial pressure but also compensates for the company's shortcomings in commercial capabilities.
 

For innovative pharmaceutical companies, R&D breakthroughs are the foundation of their existence, and successful commercialization is the key to survival. Laekna Therapeutics is navigating this path fraught with opportunities and risks. In the future, the clinical data performance and commercialization efficiency of its core products will become the critical variables determining the company's valuation and development prospects.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.