LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally.

Currently, the phase III trial AFFIRM-205, to evaluate LAE002 (afuresertib) plus fulvestrant in patients with PIK3CA/AKT1/ PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer, is progressing smoothly. Patient enrollment for this phase III study was completed. The study aims to report topline results i, with plans to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration in mid-2026. In November 2025, Laekna entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization for LAE002 (afuresertib).

In February 2026, an article titled “Afuresertib plus fulvestrant for pretreated HR positive, HER2-negative, advanced breast cancer: a phase Ib trial” was published in Nature Communications, a leading international scientific journal. The article primarily reports the results of this Phase Ib clinical trial, which evaluated afuresertib in combination with fulvestrant for the treatment of pretreated HR-positive/HER2- negative advanced breast cancer. The findings indicate that this combination regimen demonstrates promising anti-tumor activity and a well-tolerated safety profile in this patient population.

LAE102 is our internally discovered monoclonal antibody against ActRIIA, the first ActRIIA-specific antibody in clinical stage development for the treatment of obesity globally.

Blocking Activin-ActRII pathway could promote muscle regeneration and reduce fat mass, positioning LAE102 as a promising drug candidate for muscle-preserving weight control. Topline results from Phase I studies of LAE102 (ActRIIA monoclonal antibody) in the U.S. and China demonstrated encouraging, dose-dependent trends in lean mass increase and fat mass reduction, as well as a well-tolerated safety profile.

Laekna team has accumulated tremendous experience and extensive knowhow in this specific field and is developing, in addition to LAE102, more drug candidates to maximize the value of targeting ActRII receptors. LAE103 is an ActRIIB-selective antibody now in Phase I SAD Study in Australia. LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Both are our internally discovered antibodies for muscle and other disease indications.